Abstract

BackgroundThere are enormous problems in recruiting depressed people into randomised controlled trials (RCTs), with numerous studies consistently failing to recruit to target (Sully et al., Trials 14:166, 2013). Given the high prevalence of—and disability associated with—depression, it is important to find ways of effectively recruiting to RCTs evaluating interventions. This study aimed to test the feasibility of using a self-referral system to recruit to a brief intervention in a multi-site trial, the CLASSIC trial of self-confidence workshops for depression. In that trial, participants referred themselves to a depression intervention with a positive non-diagnostic title of ‘self-confidence’, given the close relationship of depression and self-esteem (Horrell et al., Br J Psychiatry 204:222–233, 2014).MethodWe analysed uptake and retention rates by recruitment to the study, attendance at the workshops and follow-up rates. However, because of the rapid rate of recruitment, we decided to pause the trial and revise our original single-site research protocol in months 5–6. We report findings under three main headings: recruitment rates for the 12 months of the project before and after the pause; data regarding attendance at the workshops before and after the pause; and the follow-up rates before and after the pause.ResultsWe recruited 459 participants within 12 months, representing 38 participants recruited per month. Improved uptake of the intervention and retention after the development of multi-site research protocols are reported.DiscussionBased on previous evidence from RCT recruitment among depressed participants, our recruitment rate demonstrates that a self-referral system using a non-diagnostic title of self-confidence is a successful recruitment method. The implications of rapid recruitment using a self-referral system are described, including the impact on uptake of the intervention as well as participant retention. Because of the potential for recruiting many participants quickly, research teams need to be adequately resourced and the oversight committees prepared to meet at shorter intervals with RCTs of brief interventions.Short conclusionSelf-referral to a brief intervention for depression with a non-diagnostic title can be a very effective way of recruiting depressed people into trials. However, there are also some challenges.Trial registrationISRCTN, ISRCTN26634837. Registered on 10 June 2010.

Highlights

  • There are enormous problems in recruiting depressed people into randomised controlled trials (RCTs), with numerous studies consistently failing to recruit to target (Sully et al, Trials 14:166, 2013)

  • Based on previous evidence from RCT recruitment among depressed participants, our recruitment rate demonstrates that a self-referral system using a non-diagnostic title of self-confidence is a successful recruitment method

  • We found poor attendance at follow-up meetings. It was only after changing the title from ‘depression workshops’ to ‘self-confidence workshops’ that we found an appreciable increase in recruitment, from people who had not previously sought help [22]

Read more

Summary

Introduction

There are enormous problems in recruiting depressed people into randomised controlled trials (RCTs), with numerous studies consistently failing to recruit to target (Sully et al, Trials 14:166, 2013). Randomised controlled trials (RCTs) are the gold standard for assessing the effectiveness of any intervention [5]. An examination of 114 trials funded by two UK agencies (MRC and NIHR Health Technology Assessment (HTA) programmes) conducted between 1994 and 2002 [6] showed that less than a third (31%) reached their original recruitment targets, with over half (53%) needing extensions. In the sequel to that study with 73 trials conducted between 2002 and 2008 [5], a slight improvement was found with 55% recruiting to their original targets and just under half (45%) needing an extension. In the worst-case scenario, recruitment problems have led to some studies being abandoned [7]

Objectives
Methods
Results
Discussion
Conclusion
Full Text
Paper version not known

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call

Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.