Using the Online Psychotherapy Tool to Address Mental Health Problems in the Context of the COVID-19 Pandemic: Protocol for an Electronically Delivered Cognitive Behavioral Therapy Program

Background The considerable rise of mental health challenges during the COVID-19 pandemic has had detrimental effects on the public health sector and economy. To meet the overwhelming and growing demand for mental health care, innovative approaches must be employed to significantly expand mental health care delivery capacity. Although it is not feasible to increase the number of mental health care providers or hours they work in the short term, improving their time efficiency may be a viable solution. Virtually and digitally delivering psychotherapy, which has been shown to be efficient and clinically effective, might be a good method for addressing this growing demand. Objective This research protocol aims to evaluate the feasibility and efficacy of using an online, digital, asynchronous care model to treat mental health issues that are started or aggravated by stressors associated with the COVID-19 pandemic. Methods This nonrandomized controlled trial intervention will be delivered through the Online Psychotherapy Tool, a secure, cloud-based, digital mental health platform. Participants will be offered a 9-week electronically delivered cognitive behavioral therapy program that is tailored to address mental health problems in the context of the COVID-19 pandemic. This program will involve weekly self-guided educational material that provides an overview of behavioral skills and weekly homework. Participants (N=80) will receive personalized feedback from and weekly interaction with a therapist throughout the course of the program. The efficacy of the program will be evaluated using clinically validated symptomology questionnaires, which are to be completed by participants at baseline, week 5, and posttreatment. Inclusion criteria includes the capacity to consent; a primary diagnosis of generalized anxiety disorder or major depressive disorder, with symptoms that started or worsened during the COVID-19 pandemic; the ability to speak and read English; and consistent and reliable access to the internet. Exclusion criteria includes active psychosis, acute mania, severe alcohol or substance use disorder, and active suicidal or homicidal ideation. Results This study received funding in May 2020. Ethics approval was received in June 2020. The recruitment of participants began in June 2020. Participant recruitment is being conducted via social media, web-based communities, and physician referrals. To date, 58 participants have been recruited (intervention group: n=35; control group: n=23). Data collection is expected to conclude by the end of 2020. Analyses (ie, linear regression analysis for continuous outcomes and binomial regression analysis for categorical outcomes) are expected to be completed by February 2021. Conclusions If proven feasible, this care delivery method could increase care capacity by up to fourfold. The findings from this study can potentially influence clinical practices and policies and increase accessibility to care during the COVID-19 pandemic, without sacrificing the quality of care. Trial Registration ClinicalTrials.gov NCT04476667; https://clinicaltrials.gov/ct2/show/NCT04476667 International Registered Report Identifier (IRRID) DERR1-10.2196/24913

Understanding the context in which an intervention was developed informs readers about the suitability and transferability of the intervention to the context in which they are considering evaluating, adapting or using the intervention. Context here can include place, organisational and wider socio-political factors that may influence the development and/or delivery of the intervention.

P1; L44-55
Report the purpose of the intervention development process.
Clearly describing the purpose of the intervention specifies what it sets out to achieve. The purpose may be informed by research priorities, for example those identified in systematic reviews, evidence gaps set out in practice guidance such as The National Institute for Health and Care Excellence or specific prioritisation exercises such as those undertaken with patients and practitioners through the James Lind Alliance. P6-7; L86-103 Report the target population for the intervention development process.
The target population is the population that will potentially benefit from the interventionthis may include patients, clinicians, and/or members of the public. If the target population is clearly described then readers will be able to understand the relevance of the intervention to their own research or practice. Health inequalities, gender and ethnicity are features of the target population that may be relevant to intervention development processes.

P8; L114-132
Report how any published intervention development approach contributed to the development process.
Many formal intervention development approaches exist and are used to guide the intervention development process. Where a formal intervention development approach is used, it is helpful to describe the process that was followed, including any deviations. More general approaches to intervention development also exist and have been categorised as follows (3):-Target Populationcentred intervention development; evidence and theorybased intervention development; partnership intervention development; implementation-based intervention development; efficacy-based intervention development; step or phased-based intervention development; and intervention-specific intervention development (3). These approaches do not always have specific guidance that describe their use. Nevertheless, it is helpful to give a rich description of how any published approach was operationalised. Intervention development is often based on published evidence and/or primary data that has been collected to inform the intervention development process. It is useful to describe and reference all forms of evidence and data that have informed the development of the intervention because evidence bases can change rapidly, and to explain the manner in which the evidence and/or data was used.
Understanding what evidence was and was not available at the time of intervention development can help readers to assess transferability to their current situation. consensus meeting, it became increasingly apparent through the development of our guidance that this theory item could relate to either existing published theory or programme theory Report any use of components from an existing intervention in the current intervention development process Some interventions are developed with components that have been adopted from existing interventions. Clearly identifying components that have been adopted or adapted and acknowledging their original source helps the reader to understand and distinguish between the novel and adopted components of the new intervention. P11; L185-190 Report any guiding principles, people or factors that were prioritised when making decisions during the intervention development process.
Reporting any guiding principles that governed the development of the application helps the reader to understand the authors' reasoning behind the decisions that were made. These could include the examples of particular populations who views are being considered when designing the intervention, the modality that is viewed as being most appropriate, design features considered important for the target population, or the potential for the intervention to be scaled up.
Potential stakeholders can include patient and community representatives, local and national policy makers, health care providers and those paying for or commissioning health care. Each of these groups may influence the intervention development process in different ways. Specifying how differing groups of stakeholders contributed to the intervention development process helps the reader to understand how stakeholders were involved and the degree of influence they had on the overall process. Further detail on how to integrate stakeholder contributions within intervention reporting are available.
Report how the intervention changed in content and format from the start of the intervention development process.
Intervention development is frequently an iterative process. The conclusion of the initial phase of intervention development does not necessarily mean that all uncertainties have been addressed. It is helpful to list remaining uncertainties such as the intervention intensity, mode of delivery, materials, procedures, or type of location that the intervention is most suitable for. This can guide other researchers to potential future areas of research and practitioners about uncertainties relevant to their healthcare context.

P16-17; L310-334
Report any changes to interventions required or likely to be required for subgroups.
Specifying any changes that the intervention development team perceive are required for the intervention to be delivered or tailored to specific sub groups enables readers to understand the applicability of the intervention to their target population or context. These changes could include changes to personnel delivering the intervention, to the content of the intervention, or to the mode of delivery of the intervention.

P16; L314-17
Report important uncertainties at the end of the intervention development process.
Intervention development is frequently an iterative process. The conclusion of the initial phase of intervention development does not necessarily mean that all uncertainties have been addressed. It is helpful to list remaining uncertainties such as the intervention intensity, mode of delivery, materials, procedures, or type of location that the intervention is most suitable for. This can guide other researchers to potential future areas of research and P16;L310-17 practitioners about uncertainties relevant to their healthcare context. Follow TIDieR guidance when describing the developed intervention.
Interventions have been poorly reported for a number of years. In response to this, internationally recognized guidance has been published to support the high quality reporting of health care?. This guidance should therefore be followed when describing a developed intervention.

Attached
Report the intervention development process in an open access format.
Unless reports of intervention development are available people considering using an intervention cannot understand the process that was undertaken and make a judgement about its appropriateness to their context. It also limits cumulative learning about intervention development methodology and observed consequences at later evaluation, translation and implementation stages. Reporting intervention development in an open access (Gold or Green) publishing format increases the accessibility and visibility of intervention development research and makes it more likely to be read and used.
Potential platforms for open access publication of intervention development include open access journal publications, freely accessible funder reports or a study web-page that details the intervention development process.
In process

TIDieR checklist
The TIDieR (Template for Intervention Description and Replication) Checklist*:

Item
Where located ** Primary paper (page or appendix number) Other † (details) BRIEF NAME 1.
Provide the name or a phrase that describes the intervention. P 7; L 106 ______________

2.
Describe any rationale, theory, or goal of the elements essential to the intervention. P 5-6 _____________ WHAT

3.
Materials: Describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers.
Provide information on where the materials can be accessed (e.g. online appendix, URL). P 6; L 89 P 9; L147 Also see ref 20

4.
Procedures: Describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities.

5.
For each category of intervention provider (e.g. psychologist, nursing assistant), describe their expertise, background and any specific training given. P 12; L 215-230 _____________

6.
Describe the modes of delivery (e.g. face-to-face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individually or in a group. In process _____________ ** Authors -use N/A if an item is not applicable for the intervention being described. Reviewers -use '?' if information about the element is not reported/not sufficiently reported. † If the information is not provided in the primary paper, give details of where this information is available. This may include locations such as a published protocol or other published papers (provide citation details) or a website (provide the URL). ǂ If completing the TIDieR checklist for a protocol, these items are not relevant to the protocol and cannot be described until the study is complete.
* We strongly recommend using this checklist in conjunction with the TIDieR guide (see BMJ 2014;348:g1687) which contains an explanation and elaboration for each item.
* The focus of TIDieR is on reporting details of the intervention elements (and where relevant, comparison elements) of a study. Other elements and methodological features of studies are covered by other reporting statements and checklists and have not been duplicated as part of the TIDieR checklist. When a randomised trial is being reported, the TIDieR checklist should be used in conjunction with the CONSORT statement (see www.consort-statement.org) as an extension of Item 5 of the CONSORT 2010 Statement. When a clinical trial protocol is being reported, the TIDieR checklist should be used in conjunction with the SPIRIT statement as an extension of Item 11 of the SPIRIT 2013