RESPOND (REducing Stress and Preventing Depression): comparing guided internet-based rumination focused cognitive behavioural therapy (i-RFCBT) versus a no-intervention control to prevent depression in high ruminating young adults, with adjunct assessment of the feasibility of unguided i-RFBCT: Study protocol for a phase III randomised-controlled trial

Abstract

Background: Depression is a global health challenge. Prevention is highlighted as a priority to reduce its prevalence. Although there are effective preventive interventions, efficacy and coverage can be improved. One proposed means to increase efficacy is by targeting interventions at specific risk factors, such as rumination. Rumination-focused CBT (RFCBT) was developed to specifically target depressive rumination, and reduces acute depressive symptoms and relapse for patients with residual depression in a randomised-controlled trial. Preliminary findings from a Dutch randomised prevention trial in 251 high-risk 15-22-year-olds selected with elevated worry and rumination found that both supported internet-RFBCT and group-delivered RFCBT equally reduced depressive symptoms and onset of depressive cases over 1 year, relative to no-intervention control. Methods/design: A Phase III randomised controlled trial following the MRC Complex Interventions Framework, to extend the Dutch trial in the UK, with the addition of diagnostic interviews, primarily testing whether guided internet-RFCBT reduces onset of depression relative to no-intervention control. High risk young adults (aged 18-24), selected with elevated worry/rumination, recruited through universities and internet advertisement, will be randomised to receive either guided internet-RFCBT, supported by clinical psychologists or mental health paraprofessionals, or no-intervention control. As an adjunct arm, participants are also randomised to unguided internet-RFCBT self-help, in order to provide an initial test of the feasibility and effect size of this intervention. While participants are also randomised to unguided internet-RFCBT, the trial was designed and powered as a Phase III trial comparing guided internet-RFCBT versus no-intervention control. In the comparison between these two arms, the primary outcomes are: a) onset of major depressive episode over a 12-month period, assessed with Structured Clinical Interview for Diagnosis 3 months (post-intervention), 6 months and 15 months after randomisation. Secondary outcomes will be collected on: incidence of generalized anxiety disorder, symptoms of depression and anxiety; levels of worry and rumination, measured at baseline and the same follow-up intervals. In relation to the pilot investigation of unguided internet-RFCBT (adjunct intervention arm), we will assess the feasibility and acceptability of data collection procedures, levels of attrition, effect size and acceptability of the unguided internet-RFCBT intervention. Discussion: Widespread implementation is necessary for effective prevention, suggesting that the internet may be a valuable mode of delivery. Previous research suggests guided internet-RFCBT reduces incidence rates relative to controls. We are also interested in developing and evaluating an unguided version to potentially increase availability and reduce costs. Trial Registration: Current Controlled Trials ISRCTN12683436. Date of registration: 27/10/2014 Key Words: Randomised Controlled Trial; Cognitive Behavioural Therapy (CBT); Rumination; Depression; Prevention; Internet-Delivery