Reducing Stress and Preventing Depression (RESPOND): Randomized Controlled Trial of Web-Based Rumination-Focused Cognitive Behavioral Therapy for High-Ruminating University Students

• Published in: Journal of medical Internet research 2019-05, Vol.21 (5), p.e11349
• Main Authors: Cook, Lorna, Mostazir, Mohammod, Watkins, Edward
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Advertisements; Anxiety; Behavior modification; Behavioral health care; Care and treatment; Clinical trials; Cognitive behavioral therapy; Cognitive Behavioral Therapy - methods; Cognitive therapy; College students; Colleges & universities; Compliance; Depression - prevention & control; Depression - therapy; Evidence-based medicine; Feasibility; Feasibility studies; Female; High risk; Humans; Internet; Internet/Web advertising; Intervention; Male; Mental depression; Original Paper; Prevention; Prevention programs; Product development; Questionnaires; Risk factors; Risk reduction; Rumination; Rumination, Cognitive - physiology; Self evaluation; Stress; Stress (Psychology); Stress management; Students; Symptoms; Therapists; Universities; University students; Young Adult; Youth
• ISSN: 1438-8871; 1439-4456; 1438-8871
• DOI: 10.2196/11349

Prevention of depression is a priority to reduce its global disease burden. Targeting specific risk factors, such as rumination, may improve prevention. Rumination-focused Cognitive Behavioral Therapy (RFCBT) was developed to specifically target depressive rumination. The primary objective of this study was to test whether guided Web-based RFCBT (i-RFCBT) would prevent the incidence of major depression relative to usual care in UK university students. The secondary objective was to test the feasibility and estimated effect sizes of unguided i-RFCBT. To address the primary objective, a phase III randomized controlled trial was designed and powered to compare high risk university students (N=235), selected with elevated worry/rumination, recruited via an open access website in response to circulars within universities and internet advertisements, randomized to receive either guided i-RFCBT (interactive Web-based RFCBT, supported by asynchronous written Web-based support from qualified therapists) or usual care control. To address the secondary objective, participants were also randomized to an adjunct arm of unguided (self-administered) i-RFCBT. The primary outcome was the onset of a major depressive episode over 15 months, assessed with structured diagnostic interviews at 3 (postintervention), 6, and 15 months post randomization, conducted by telephone, blind to the condition. Secondary outcomes of symptoms of depression and anxiety and levels of worry and rumination were self-assessed through questionnaires at baseline and the same follow-up intervals. Participants were randomized to guided i-RFCBT (n=82), unguided i-RFCBT (n=76), or usual care (n=77). Guided i-RFCBT reduced the risk of depression by 34% relative to usual care (hazard ratio [HR] 0.66, 95% CI 0.35 to 1.25; P=.20). Participants with higher levels of baseline stress benefited most from the intervention (HR 0.43, 95% CI 0.21 to 0.87; P=.02). Significant improvements in rumination, worry, and depressive symptoms were found in the short-to-medium term. Of the 6 modules, guided participants completed a mean of 3.46 modules (SD 2.25), with 46% (38/82) being compliant (completing ≥4 modules). Similar effect sizes and compliance rates were found for unguided i-RFCBT. Guided i-RFCBT can reduce the onset of depression in high-risk young people reporting high levels of worry/rumination and stress. The feasibility study argues for formally testing unguided i-RFCBT for prevention: if the observed effect