TY - JOUR
T1 - Effect of Sleep Disturbance Symptoms on Treatment Outcome in Blended Cognitive Behavioral Therapy for Depression (E-COMPARED Study): Secondary Analysis
T2 - Secondary Analysis
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
N1 - Publisher Copyright: ©Esben Skov Jensen, Nicolai Ladegaard, Angelina Isabella Mellentin, David Daniel Ebert, Ingrid Titzler, Ricardo Araya, Arlinda Cerga Pashoja, Jean-Baptiste Hazo, Jérôme Holtzmann, Roman Cieslak, Ewelina Smoktunowicz, Rosa Baños, Rocio Herrero, Azucena García-Palacios, Cristina Botella, Thomas Berger, Tobias Krieger, Trine Theresa Holmberg, Naira Topooco, Gerhard Andersson, Annemieke van Straten,
PY - 2022/3/21
Y1 - 2022/3/21
N2 - 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.
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.
KW - bCBT
KW - blended care
KW - cognitive behavioral therapy
KW - digital health
KW - digital intervention
KW - major depressive disorder
KW - mental health
KW - mobile phone
KW - sleep disorder
KW - sleep disturbance
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U2 - https://doi.org/10.2196/30231
DO - https://doi.org/10.2196/30231
M3 - Article
C2 - 35311687
SN - 1438-8871
VL - 24
SP - 1
EP - 13
JO - Journal of Medical Internet Research
JF - Journal of Medical Internet Research
IS - 3
M1 - e30231
ER -