TY - JOUR AU - Jensen, Esben Skov AU - Ladegaard, Nicolai AU - Mellentin, Angelina Isabella AU - Ebert, David Daniel AU - Titzler, Ingrid AU - Araya, Ricardo AU - Cerga Pashoja, Arlinda AU - Hazo, Jean-Baptiste AU - Holtzmann, Jérôme AU - Cieslak, Roman AU - Smoktunowicz, Ewelina AU - Baños, Rosa AU - Herrero, Rocio AU - García-Palacios, Azucena AU - Botella, Cristina AU - Berger, Thomas AU - Krieger, Tobias AU - Holmberg, Trine Theresa AU - Topooco, Naira AU - Andersson, Gerhard AU - van Straten, Annemieke AU - Kemmeren, Lise AU - Kleiboer, Annet AU - Riper, Heleen AU - Mathiasen, Kim PY - 2022 DA - 2022/3/21 TI - Effect of Sleep Disturbance Symptoms on Treatment Outcome in Blended Cognitive Behavioral Therapy for Depression (E-COMPARED Study): Secondary Analysis JO - J Med Internet Res SP - e30231 VL - 24 IS - 3 KW - blended care KW - bCBT KW - cognitive behavioral therapy KW - digital intervention KW - major depressive disorder KW - sleep disturbance KW - sleep disorder KW - mental health KW - digital health KW - mobile phone AB - Background: Sleep disturbance symptoms are common in major depressive disorder (MDD) and have been found to hamper the treatment effect of conventional face-to-face psychological treatments such as cognitive behavioral therapy. To increase the dissemination of evidence-based treatment, blended cognitive behavioral therapy (bCBT) consisting of web-based and face-to-face treatment is on the rise for patients with MDD. To date, no study has examined whether sleep disturbance symptoms have an impact on bCBT treatment outcomes and whether it affects bCBT and treatment-as-usual (TAU) equally. Objective: The objectives of this study are to investigate whether baseline sleep disturbance symptoms have an impact on treatment outcomes independent of treatment modality and whether sleep disturbance symptoms impact bCBT and TAU in routine care equally. Methods: The study was based on data from the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment Versus Treatment-as-Usual) study, a 2-arm, multisite, parallel randomized controlled, noninferiority trial. A total of 943 outpatients with MDD were randomized to either bCBT (476/943, 50.5%) or TAU consisting of routine clinical MDD treatment (467/943, 49.5%). The primary outcome of this study was the change in depression symptom severity at the 12-month follow-up. The secondary outcomes were the change in depression symptom severity at the 3- and 6-month follow-up and MDD diagnoses at the 12-month follow-up, assessed using the Patient Health Questionnaire-9 and Mini-International Neuropsychiatric Interview, respectively. Mixed effects models were used to examine the association of sleep disturbance symptoms with treatment outcome and treatment modality over time. Results: Of the 943 patients recruited for the study, 558 (59.2%) completed the 12-month follow-up assessment. In the total sample, baseline sleep disturbance symptoms did not significantly affect change in depressive symptom severity at the 12-month follow-up (β=.16, 95% CI –0.04 to 0.36). However, baseline sleep disturbance symptoms were negatively associated with treatment outcome for bCBT (β=.49, 95% CI 0.22-0.76) but not for TAU (β=–.23, 95% CI −0.50 to 0.05) at the 12-month follow-up, even when adjusting for baseline depression symptom severity. The same result was seen for the effect of sleep disturbance symptoms on the presence of depression measured with Mini-International Neuropsychiatric Interview at the 12-month follow-up. However, for both treatment formats, baseline sleep disturbance symptoms were not associated with depression symptom severity at either the 3- (β=.06, 95% CI −0.11 to 0.23) or 6-month (β=.09, 95% CI −0.10 to 0.28) follow-up. Conclusions: Baseline sleep disturbance symptoms may have a negative impact on long-term treatment outcomes in bCBT for MDD. This effect was not observed for TAU. These findings suggest that special attention to sleep disturbance symptoms might be warranted when MDD is treated with bCBT. Future studies should investigate the effect of implementing modules specifically targeting sleep disturbance symptoms in bCBT for MDD to improve long-term prognosis. SN - 1438-8871 UR - https://www.jmir.org/2022/3/e30231 UR - https://doi.org/10.2196/30231 UR - http://www.ncbi.nlm.nih.gov/pubmed/35311687 DO - 10.2196/30231 ID - info:doi/10.2196/30231 ER -