Efficacy of a Theory-Based Cognitive Behavioral Technique App-Based Intervention for Patients With Insomnia: Randomized Controlled Trial

Background Sleep hygiene is important for maintaining good sleep and reducing insomnia. Objective This study examined the long-term efficacy of a theory-based app (including cognitive behavioral therapy [CBT], theory of planned behavior [TPB], health action process approach [HAPA], and control theory [CT]) on sleep hygiene among insomnia patients. Methods The study was a 2-arm single-blind parallel-group randomized controlled trial (RCT). Insomnia patients were randomly assigned to a treatment group that used an app for 6 weeks (ie, CBT for insomnia [CBT-I], n=156) or a control group that received only patient education (PE, n=156) through the app. Outcomes were assessed at baseline and 1 month, 3 months, and 6 months postintervention. Primary outcomes were sleep hygiene, insomnia, and sleep quality. Secondary outcomes included attitudes toward sleep hygiene behavior, perceived behavioral control, behavioral intention, action and coping planning, self-monitoring, behavioral automaticity, and anxiety and depression. Linear mixed models were used to evaluate the magnitude of changes in outcomes between the two groups and across time. Results Sleep hygiene was improved in the CBT-I group compared with the PE group (P=.02 at 1 month, P=.04 at 3 months, and P=.02 at 6 months) as were sleep quality and severity of insomnia. Mediation analyses suggested that perceived behavioral control on sleep hygiene as specified by TPB along with self-regulatory processes from HAPA and CT mediated the effect of the intervention on outcomes. Conclusions Health care providers might consider using a CBT-I app to improve sleep among insomnia patients. Trial Registration ClinicalTrials.gov NCT03605732; https://clinicaltrials.gov/ct2/show/NCT03605732

1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "E cacy of a theory-based cognitive behavioral technique app-intervention for patients with insomnia: A randomized controlled trial " subitem not at all important 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study the item is not applicable/relevant for our study 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "E cacy of a theory-based cognitive behavioral technique app-intervention for patients with insomnia: A randomized controlled trial " Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The present study examined the long-term e cacy of a theory-based app (including cognitive behavioral theory [CBT], theory of planned behavior [TPB], health action process approach [HAPA], and control theory [CT]) on sleep hygiene among insomnia patients." 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study was a two-arm single-blind parallel-group randomized controlled trial (RCT). Insomnia patients were randomly assigned to a treatment group who received access to an app for six weeks " 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional o ine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Insomnia patients were randomly assigned to a treatment group who received access to an app for six weeks (i.e., CBT on insomnia; CBT-I; n=156) or a control group receiving patient education (PE; n=156). " INTRODUCTION 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "CBT on insomnia; CBT-I; n=156) or a control group receiving patient education (PE; n=156) " 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Healthcare providers might consider using a CBT-I app to improve sleep among insomnia patients." Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Good sleep hygiene practices are often one of the rst steps in treating insomnia. Sleep hygiene refers to a variety of behaviors that promote sleep quality.
[6] Sleep promoting behaviors include among else avoiding going to bed hungry or thirsty, avoiding stress and anxiety, avoiding physical activity before going to bed, and preparing a bedroom that provides a relaxed environment limiting activities in the bedroom to sleep and sexual activities.
[7] However, behavioral modi cations to improve sleep quality can be hard to achieve; many patients with insomnia reported that they have tried to modify their poor sleep habits without any effect. Dysfunctional or unrealistic sleep expectations, and excessive worrying over sleep loss appear to contribute to poor sleep hygiene. For instance, a Japanese study found that sleep hygiene behaviors are confounded by sleep beliefs.
[8] Additionally, due to the rise of mobile technologies, many individuals now use electronic devices in bed, and this may restrict individuals with insomnia from practicing good sleep hygiene (e.g., being too excited to sleep due to the use of media).
[9] Consequently, interventions are needed to help individuals with insomnia to actually practice sleep hygiene.
However, simply providing intervention on sleep hygiene behaviors for individuals with insomnia is insu cient. A review paper of qualitative studies showed that individuals suffering from insomnia observe the ine ciency of sleep hygiene practice delivered by the healthcare providers. In particular, healthcare providers are found to have limited knowledge in sleep hygiene (i.e., they only know a few basic principles) and most providers are unable to incorporate theoretical models or techniques to deliver sleep hygiene.
[10] Therefore, interventions concerning sleep hygiene behaviors should incorporate robust and effective theoretical models. Indeed, in a systematic review and meta-analysis, Webb et al. found that using theories as a framework in designing online interventions led to a substantial effect on outcome variables. [11] Theoretical models can help to select the components of the intervention and help in the evaluation of the intervention's impact. [12][13][14][15][16][17][18][19][20][21][22]  Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The present study aimed to determine the long-term treatment e cacy of a theory-based app using CBT, TPB, HAPA, and CT on sleep hygiene among insomnia patients. The primary evaluation involved comparing sleep hygiene behaviors and sleep quality with a control group that received patient education (PE). " Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A two-arm single-blind parallel-group RCT was launched to compare CBT-I and PE groups via an App over a six-month period" subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study the item is not applicable/relevant 3b-i) Bug xes, Downtimes, Content Changes Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study the item is not applicable/relevant Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "having access to a smartphone and/or a desktop computer with internet access" 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This Iranian-based study was advertised using brochures and posters at three universities, ve colleges, and ten general physicians' o ces as well as on social media. Interested participants were asked to access an online platform speci cally designed for the study to complete a screening questionnaire assessing insomnia symptoms comprising the Insomnia Severity Index (ISI), sleep characteristics, and medical history, as well as their time spent on computers and online. If the participants meet the initial criteria and express interest, a phone appointment is scheduled to conducted additional eligibility assessments" 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study After expressing objectives, assuring the participants about con dentiality of" their data and possibility of withdrawing from the study, the written informed consent form was signed by those participants who were willing to participate in " .this research by the three research assistants Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This Iranian-based study was advertised using brochures and posters at three universities, ve colleges, and ten general physicians' o ces as well as on social media. Interested participants were asked to access an online platform speci cally designed for the study to complete a screening 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "All participants completed a socio-demographic pro le questionnaire (age, gender, educational status, occupational status) " 4b-ii) Report how institutional a liations are displayed Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 5) The interventions for each group with su cient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer 5-i) Mention names, credential, a liations of the developers, sponsors, and owners Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Partial nancial support by Research Vice Chancellor of Qazvin University of Medical Sciences for the project is appreciated."

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "the item is not applicable"

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study the item is not applicable/relevant

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer -v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Table 2 further illustrates how the BCTs work on speci c targeted outcomes "

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "the app has provided by a web-page" planning, and problem-solving. The intervention contents were designed across six weeks, with exercises and sub-tutorials automatically provided each week (Table 1). Table 2 further illustrates how the BCTs work on speci c targeted outcomes."

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study ". Participants in both groups received assistance from a trained research assistant to help them install and unlock the app. To avoid contamination, participants in the PE group could not access to the CBT-I content and this part was locked using a personal code. " subitem not at all important 1 2 3 4 5 essential 6a) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Procedure in PE Participants in the PE group received written weekly information on accurate and relevant information regarding insomnia symptoms, physiological controls of sleep, sleep hygiene practices, healthy sleep behaviors (e.g., reduce time in bed, get up at the same time every day, go to bed only if sleepy, and do not stay in bed unless asleep) and changing lifestyle to promote sleep health. The information was designed in a separate content from the CBT-I in the App. This weekly information was locked for the participants and was unlocked on weekly bases.
Participants in the PE group were informed and could access the CBT-I content of the app at the end of the study (i.e., 6 months after the completing the intervention). " subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants in the PE group received written weekly information on accurate and relevant information regarding insomnia symptoms, physiological controls of sleep, sleep hygiene practices, healthy sleep behaviors (e.g., reduce time in bed, get up at the same time every day, go to bed only if sleepy, and do not stay in bed unless asleep) and changing lifestyle to promote sleep health. The information was designed in a separate content from the CBT-I in the App. This weekly information was locked for the participants and was unlocked on weekly bases.
Participants in the PE group were informed and could access the CBT-I content of the app at the end of the study (i.e., 6 months after the completing the intervention)." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text "Measures All participants completed a socio-demographic pro le questionnaire (age, gender, educational status, occupational status) at the baseline assessment. Primary and secondary outcomes were assessed using a variety of measures outlined below.
Primary outcomes Sleep hygiene behavior. Sleep hygiene behavior was assessed using three items. The participants were asked to report how many days they had good sleep hygiene behavior over the past week ('How many days did you make your bedroom restful over the past week?') and then whether they avoided going to bed feeling hungry or thirsty, and avoided anxiety and stressprovoking activity before bed. Participants were asked to respond on an 8point scale ranging from 0 to 7. The internal consistency of the three items were found to be acceptable in a previous study (α = 0.78). [37] Insomnia Severity Index (ISI). The ISI is a seven-item self-report scale that assesses participants' level of insomnia over the past two weeks. All items are rated on a ve-point Likert-type scale ranging from 0 (no problem) to 4 (very severe problem). A total score is generated by summing up all seven items ranging from 0-28 with ve sub-scores: 0-7 (absence of insomnia),  (PBC). PBC was assessed using three items (e.g., 'I am con dent that every day I can prevent anxiety-provoking activity before bedtime'). All items were scored on a ve-point Likert scale, ranging from 1 (totally disagree) to 5 (totally agree). The scale has proved internally consistent in previous studies. [24,37] Behavioral intention. Behavioral intention was assessed using six items (e.g., 'Over the next week, I intend to make my bedroom restful'). All items were scored on a ve-point Likert scale, ranging from 1 (totally disagree) to 5 (totally agree). Internal consistency of this six-item scale has been found acceptable in previous studies. [24,37] Action planning. Action planning was assessed using four items. The participants were asked to indicate if have made a detailed plan regarding (i) when, (ii) where, (iii) how, and (iv) how often they will perform sleep hygiene behaviors over the next six months. All items were scored on a ve-point Likert scale, ranging from 1 (totally disagree) to 5 (totally agree). The internal consistency of this four-item scale has been found acceptable in previous studies. [24,37,46] Coping planning. Coping planning was assessed using ve items (e.g., 'I have made a detailed plan regarding what to do if something interferes with my plans'). All items were scored on a ve-point Likert scale, ranging from 1 (totally disagree) to 5 (totally agree). Internal consistency of this ve-item scale has been found acceptable in previous studies.[24,37,47] Self-monitoring. Self-monitoring was assessed by three items (i.e., "I keep track of how much time I spend sleeping", "I pay attention to how tired or rested I feel each day", and "I take care to note the time that I go to bed and wake each day). Responses were rated on a scale ranging from 1 (never) to 5 (always). Self-report Behavioral Automaticity Index (SRBAI). The extent to which the sleep hygiene behaviors are habitual for an individual was assessed using the SRBAI. The SRBAI contains four items that starts with the stem "Sleep hygiene behavior is something…" following by "I do automatically', 'I do without having to consciously remember', 'I do without thinking', and 'I start doing before I realize I'm doing it'. The reliability of the Persian SRBAI has been reported.
[48] Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item scale that assesses anxiety (seven items) and depression (seven items) in patients with both somatic and mental problems. All items were scored on a 0-3 scale with higher score representing higher levels of anxiety and depression. The subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Your answer 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Your answer Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study the item is not applicable/relevant for our study 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Randomization and allocation procedures Participants who met the inclusion criteria and signed the informed consent were randomly assigned to a control group (PE) or a treatment group (CBT-I) at a 1:1 ratio. Randomization was performed by an independent researcher via a random list generated utilizing SPSS 24.0. Because blinding participants from treatment condition was impossible, the study blinded the data analyst using a code system for treatment condition. Moreover, the data analyst did not have access to the key document. Participants in both groups received assistance from a trained research assistant to help them install and unlock the app. To avoid contamination, participants in the PE group could not access to the CBT-I content and this part was locked using a personal code.

"
Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study the item is not applicable/relevant for our study 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Randomization was performed by an independent researcher via a random list generated utilizing SPSS 24.0" Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Randomization was performed by an independent researcher via a random list generated utilizing SPSS 24." 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Because blinding participants from treatment condition was impossible, the study blinded the data analyst using a code system for treatment condition. Moreover, the data analyst did not have access to the key document.
Participants in both groups received assistance from a trained research assistant to help them install and unlock the app. To avoid contamination, participants in the PE group could not access to the CBT-I content and this part was locked using a personal code. " 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Because blinding participants from treatment condition was impossible, the study blinded the data analyst using a code system for treatment condition. Moreover, the data analyst did not have access to the key document.
Participants in both groups received assistance from a trained research assistant to help them install and unlock the app. To avoid contamination, participants in the PE group could not access to the CBT-I content and this part was locked using a personal code. " 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Procedure in PE Participants in the PE group received written weekly information on accurate and relevant information regarding insomnia symptoms, physiological controls of sleep, sleep hygiene practices, healthy sleep behaviors (e.g., reduce time in bed, get up at the same time every day, go to bed only if sleepy, and do not stay in bed unless asleep) and changing lifestyle to promote sleep health. The information was designed in a separate content from the CBT-I in the App. This weekly information was locked for the participants and was unlocked on weekly bases.
Participants in the PE group were informed and could access the CBT-I content of the app at the end of the study (i.e., 6 months after the completing the intervention). " subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Statistical methods All statistical analyses were performed in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines. Also, intention-to-treat (ITT) analyses were carried out to tackle attrition. Descriptive statistics were used to summarize the characteristics of the participants. To evaluate the magnitude of changes in primary and secondary outcomes over time across the two groups, linear mixed models (PROCMIXED) were performed, controlling for baseline variables and other covariates that may relate to the outcome. The mixed modeling approach is a powerful statistical tool to evaluate group differences over time that has unequal numbers of participants at baseline and follow-up. It is also a helpful way to handle missing data using full information maximum likelihood estimation. The analysis incorporated two betweenparticipant effects (between groups and between participants within groups) and three within-participant effects (between times, group by time interactions, and random variation). All p-values were two-sided and were evaluated as statistically signi cant at the 0.05 level. All statistical analyses were performed using SAS version 9.3 (SAS Institute Inc., Cary, NC, USA). " 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Statistical methods" All statistical analyses were performed in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines. Also, intention-to-treat (ITT) analyses were carried out to tackle attrition. Descriptive statistics were used to summarize the characteristics of the participants. To evaluate the magnitude of changes in primary and secondary outcomes over time across the two groups, linear mixed models (PROCMIXED) were performed, controlling for baseline variables and other covariates that may relate to the outcome. The mixed modeling approach is a powerful statistical tool to evaluate group differences over time that has unequal numbers of participants at baseline and follow-up. It is also a helpful way to handle missing data using full information maximum likelihood estimation. The analysis incorporated two betweenparticipant effects (between groups and between participants within groups) and three within-participant effects (between times, group by time interactions, and random variation). All p-values were two-sided and were evaluated as statistically signi cant at the 0.05 level. All statistical analyses were performed .(using SAS version 9.3 (SAS Institute Inc., Cary, NC, USA " X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Statistical methods All statistical analyses were performed in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines. Also, intention-to-treat (ITT) analyses were carried out to tackle attrition. Descriptive statistics were used to summarize the characteristics of the participants. To evaluate the magnitude of changes in primary and secondary outcomes over time across the two groups, linear mixed models (PROCMIXED) were performed, controlling for baseline variables and other covariates that may relate to the outcome. The mixed modeling approach is a powerful statistical tool to evaluate group differences over time that has unequal numbers of participants at baseline and follow-up. It is also a helpful way to handle missing data using full information maximum likelihood estimation. The analysis incorporated two betweenparticipant effects (between groups and between participants within groups) and three within-participant effects (between times, group by time interactions, and random variation). All p-values were two-sided and were evaluated as statistically signi cant at the 0.05 level. All statistical analyses were performed using SAS version 9.3 (SAS Institute Inc., Cary, NC, USA). " X26-i) Comment on ethics committee approval subitem not at all important 1 2 3 4 5 essential Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The present study protocol was approved by the Ethics Committee of Qazvin University of Medical Sciences (IR.QUMS.REC.1396.455) and is registered with ClinicalTrials.gov (Identi er: NCT03605732; last updated July 2018). This study was performed based on the Helsinki Declaration principles. Required permissions were obtained from authorities of Qazvin University of Medical Sciences. After expressing objectives, assuring the participants about con dentiality of their data and possibility of withdrawing from the study, the written informed consent form was signed by those participants who were willing to participate in this research by the three research assistants. "

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained o ine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The present study protocol was approved by the Ethics Committee of Qazvin University of Medical Sciences (IR.QUMS.REC.1396.455) and is registered with ClinicalTrials.gov (Identi er: NCT03605732; last updated July 2018). This study was performed based on the Helsinki Declaration principles. Required permissions were obtained from authorities of Qazvin University of Medical Sciences. After expressing objectives, assuring the participants about con dentiality of their data and possibility of withdrawing from the study, the written informed consent form was signed by those participants who were willing to participate in this research by the three research assistants. " subitem not at all important 1 2 3 4 5 essential RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons X26-iii) Safety and security procedures Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The ow chart of the study design is shown in Figure 1" subitem not at all important 1 2 3 4 5 essential 14a) Dates de ning the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The ow chart of the study design is shown in Figure 1" 13b-i) Attrition diagram Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The ow chart of the study design is shown in Figure 1" Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The present study protocol was approved by the Ethics Committee of Qazvin Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " 16-i) Report multiple "denominators" and provide de nitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Effects of the intervention on primary outcomes" " Table 5" 16-ii) Primary analysis should be intent-to-treat Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " Table 5" subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespeci ed from exploratory 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study the item is not applicable Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The present research found that a theory-based intervention improved sleep outcomes among insomnia patients in Iran, as evidenced by improved sleep hygiene behaviors, increased sleep quality, and decreased insomnia severity.
These bene cial effects were mediated by several changes in the putative determinants of behavior, including the perceived behavioral control in the TPB, action and coping planning in the HAPA, and self-monitoring and behavioral automaticity in the CT. Moreover, the entire treatment effects were guided by the CBT (i.e., the use of BCTs Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. 21) Generalisability (external validity, applicability) of the trial ndings NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "There are some limitations in the study. First, the participants were not representative of the entire population of Iranian patients with insomnia. For example, participants in the present study needed to use the app to receive the intervention. Therefore, insomnia patients who have little literacy in using smartphone or desktop computer may not gain bene t from the CBT-I. Following by the rst limitation, given that the mean age of the studied sample was midthirties; the possibility to generalize our ndings to all inhabitants/age group is low. Second, the use of self-report measures for sleep and mental health outcomes could be biased by social desirability or memory recall. Although mental health outcomes are hard to measure using non-self-reports, future studies may want to use objectively measured instruments on sleep quality (e.g., actigraphy). Third, the participants could not be blinded because the intervention was obvious to them. Therefore, the placebo effects were hard to be excluded; especially most of the outcome measures were self-reported. However, given that the promising effects were found across all the outcome measures and the placebo effects would be unlikely to last six months after treatment ends, we tentatively concluded that the CBT-I is an effective program to treat insomnia.
Lastly, as the study only followed up to six months after completing the intervention, it is unclear whether the CBT-I can last the effects longer than six months. Future studies are thus warranted to examine a long-term effect of the CBT-I." Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Trial Registration: NCT03605732" Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Trial Registration: NCT03605732" Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "No nancial support for disseminating the protocol." X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention. STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document Any other comments or questions on CONSORT EHEALTH Your answer