Margrit Löbner1, Alexander Pabst2, Janine Stein3, Marie Dorow3, Herbert Matschinger3, Melanie Luppa3, Astrid Maroß4, Anette Kersting5, Hans-Helmut König6, Steffi G Riedel-Heller3. 1. Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, Philipp-Rosenthal-Str. 55, 04103 Leipzig, Germany. Electronic address: Margrit.Loebner@medizin.uni-leipzig.de. 2. Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, Philipp-Rosenthal-Str. 55, 04103 Leipzig, Germany. Electronic address: Alexander.Pabst@medizin.uni-leipzig.de. 3. Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, Philipp-Rosenthal-Str. 55, 04103 Leipzig, Germany. 4. Federal Association of the AOK (Statutory Health Insurance Found), Berlin, Germany. 5. Clinic of Psychosomatic Medicine and Psychotherapy, University of Leipzig, Leipzig, Germany. 6. Department of Health Economics and Health Services Research, Hamburg Centre for Health Economics, University Medical Centre Hamburg-Eppendorf, University of Hamburg, Hamburg, Germany.
Abstract
BACKGROUND:Self-guided computerized cognitive behavior therapy (cCBT) has the potential to be a feasible alternative to current first-step treatment approaches for depression. Yet, research regarding the effectiveness and acceptability of self-guided cCBT as an adjunct element of GP care is controversial. METHODS:Primary care patients with symptoms of mild to moderately severe depression (N = 647) were recruited from 112 GP practices within a cluster randomized controlled trial. GPs were randomized to groups that provided either cCBT (internet intervention) plus treatment as usual (TAU) or TAU alone. Primary outcomes were self-reported depression severity according to the Beck Depression Inventory (BDI-II) and Patient Health Questionnaire (PHQ-9). Intention to treat (ITT) and per protocol (PP) analysis was performed. RESULTS: ITT analyses showed significant between group differences in depressive symptoms for BDI-II in favor of the intervention group, corresponding to a small effect size (6 weeks: d = 0.36, 95% CI 0.19 to 0.53, P < .001; 6 months: d = 0.41, 95% 0.22 to 0.59, P < .001). The number needed to treat (NNT) at six months was 6.2. PHQ-9 analyses was solely significant at six months (d = 0.26, 95% CI 0.08 to 0.44, P < .05, NNT = 9.2). PP analyses highly agree with these findings. LIMITATIONS: The initial response rate with regard to the recruitment of GP practices for the trial was low. CONCLUSIONS: The results suggest that cCBT is effective in reducing depressive symptoms in mildly to moderately severe depressed primary care patients. Efforts should be made to raise awareness about the potential of such freely accessible treatment options among GPs and patients.
RCT Entities:
BACKGROUND: Self-guided computerized cognitive behavior therapy (cCBT) has the potential to be a feasible alternative to current first-step treatment approaches for depression. Yet, research regarding the effectiveness and acceptability of self-guided cCBT as an adjunct element of GP care is controversial. METHODS: Primary care patients with symptoms of mild to moderately severe depression (N = 647) were recruited from 112 GP practices within a cluster randomized controlled trial. GPs were randomized to groups that provided either cCBT (internet intervention) plus treatment as usual (TAU) or TAU alone. Primary outcomes were self-reported depression severity according to the Beck Depression Inventory (BDI-II) and Patient Health Questionnaire (PHQ-9). Intention to treat (ITT) and per protocol (PP) analysis was performed. RESULTS: ITT analyses showed significant between group differences in depressive symptoms for BDI-II in favor of the intervention group, corresponding to a small effect size (6 weeks: d = 0.36, 95% CI 0.19 to 0.53, P < .001; 6 months: d = 0.41, 95% 0.22 to 0.59, P < .001). The number needed to treat (NNT) at six months was 6.2. PHQ-9 analyses was solely significant at six months (d = 0.26, 95% CI 0.08 to 0.44, P < .05, NNT = 9.2). PP analyses highly agree with these findings. LIMITATIONS: The initial response rate with regard to the recruitment of GP practices for the trial was low. CONCLUSIONS: The results suggest that cCBT is effective in reducing depressive symptoms in mildly to moderately severe depressed primary care patients. Efforts should be made to raise awareness about the potential of such freely accessible treatment options among GPs and patients.
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