Journal Article

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

Watkins, Edward, Mostazir, Mohammod, Cook, Lorna

2019

Overview

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 sizes are robustly replicated in a phase III trial, it has potential as a scalable prevention intervention. ISRCTN Registry ISRCTN12683436; https://www.isrctn.com/ISRCTN12683436 (Archived by WebCite at http://www.webcitation.org/77fqycyBX). RR2-10.1186/s13063-015-1128-9.

• Publisher: Journal of Medical Internet Research,Gunther Eysenbach MD MPH, Associate Professor,JMIR Publications
• Subject: Adolescent / Adult / Advertisements / Advertising / Anxiety / Behavior modification / Behavioral health care / Care and treatment / Clinical trials / Cognition / 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 / Medical treatment / Mental depression / Objectives / Original Paper / Prevention / Prevention programs / Product development / Psychotherapy / Questionnaires / Risk / Risk factors / Risk reduction / Rumination / Rumination, Cognitive - physiology / Secondary school students / Self evaluation / Stress / Stress (Psychology) / Stress management / Students / Symptoms / Therapists / Universities / University students / Young Adult / Youth