JMIR Publications

ABSTRACT

Background:

Prevention of depression is a priority to reduce its global disease burden. Targeting specific risk factors, such as rumination, may increase the efficacy of preventive interventions. Rumination-focused CBT (RFCBT) was developed to specifically target depressive rumination. A prior randomised controlled trial (RCT) in Dutch 15-22-year-olds at risk because of elevated worry and rumination found that both guided web-based RFBCT (i-RFCBT) and group-delivered RFCBT equally reduced depressive symptoms and onset of depressive cases over 1-year follow-up, relative to usual care control.

Objective:

The primary objective was to test whether guided i-RFCBT would prevent the incidence of major depression relative to usual care when extended to UK university students and using diagnostic interviews to improve the assessment of incidence of depression. The secondary objective was to test the feasibility and estimated effect sizes of unguided i-RFCBT.

Methods:

To address the primary objective, a Phase III RCT 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 advertisement, randomised to receive either guided i-RFCBT (an interactive web-based version of RFCBT, supported by asynchronous written web-based support from qualified and specially trained therapists), or usual care control. To address the secondary objective, participants were also randomised to an adjunct arm of unguided (self-administered) i-RFCBT. Primary outcome was onset of a major depressive episode, assessed with structured diagnostic interview at 3 (post-intervention), 6 and 15 months post-randomisation, conducted by telephone, blind to 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.

Results:

A total of 235 participants were randomised to guided i-RFCBT (N = 82), unguided i-RFCBT (N = 76) or usual care (N = 77). For the primary comparison, guided i-RFCBT reduced risk of depression by 34% relative to usual care. Participants with higher levels of baseline stress benefited most from the intervention (HR: 0.43, 95% CI [0.21, 0.87], P = .02). Significant improvements in rumination, worry and depressive symptoms were found in the short to medium term. Of six modules, guided participants completed a mean of 3.46 modules (SD = 2.25), with 46.34% (38/82) compliant (completing ≥4 modules). Similar effect sizes and compliance rates were found for unguided i-RFCBT.

Conclusions:

These results confirm that 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 as a preventive intervention: as a scalable intervention, if the observed effect sizes are robustly replicated in a Phase III trial, it has potential to significantly address the burden of depression. Clinical Trial: Current Controlled Trials ISRCTN12683436. Date of registration: 27/10/2014