Skip to main content
Top
Published in: Trials 1/2019

Open Access 01-12-2019 | Affective Disorder | Research

How can we successfully recruit depressed people? Lessons learned in recruiting depressed participants to a multi-site trial of a brief depression intervention (the ‘CLASSIC’ trial)

Authors: June S. L. Brown, Caroline Murphy, Joanna Kelly, Kimberley Goldsmith

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

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). 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).

Method

We 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.

Results

We 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.

Discussion

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. 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 conclusion

Self-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 registration

ISRCTN, ISRCTN26634837. Registered on 10 June 2010.
Literature
1.
go back to reference Murray CJ, Lopez AD. Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study. Lancet. 1997;349(9063):1436–42.PubMedCrossRef Murray CJ, Lopez AD. Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study. Lancet. 1997;349(9063):1436–42.PubMedCrossRef
2.
go back to reference Lepine JP, et al. Depression in the community: the first pan-European study DEPRES (Depression Research in European Society). Int Clin Psychopharmacol. 1997;12(1):19–29.PubMedCrossRef Lepine JP, et al. Depression in the community: the first pan-European study DEPRES (Depression Research in European Society). Int Clin Psychopharmacol. 1997;12(1):19–29.PubMedCrossRef
3.
go back to reference Mojtabai R, et al. Barriers to mental health treatment: results from the National Comorbidity Survey Replication. Psychol Med. 2011;41(8):1751–61.PubMedCrossRef Mojtabai R, et al. Barriers to mental health treatment: results from the National Comorbidity Survey Replication. Psychol Med. 2011;41(8):1751–61.PubMedCrossRef
4.
go back to reference Clement S, et al. What is the impact of mental health-related stigma on help-seeking? A systematic review of quantitative and qualitative studies. Psychol Med. 2014;4(1):1–17. Clement S, et al. What is the impact of mental health-related stigma on help-seeking? A systematic review of quantitative and qualitative studies. Psychol Med. 2014;4(1):1–17.
5.
go back to reference Sully BG, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials. 2013;14:166.PubMedPubMedCentralCrossRef Sully BG, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials. 2013;14:166.PubMedPubMedCentralCrossRef
6.
go back to reference McDonald AM, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.PubMedPubMedCentralCrossRef McDonald AM, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.PubMedPubMedCentralCrossRef
7.
go back to reference Sibthorpe BM, et al. The demise of a planned randomised controlled trial in an urban Aboriginal medical service. MJA. 2002;176:273–6.PubMed Sibthorpe BM, et al. The demise of a planned randomised controlled trial in an urban Aboriginal medical service. MJA. 2002;176:273–6.PubMed
8.
go back to reference Woodford J, et al. Recruitment into a guided internet based CBT (iCBT) intervention for depression: lesson learnt from the failure of a prevalence recruitment strategy. Contemp Clin Trials. 2011;32:641–8.PubMedCrossRef Woodford J, et al. Recruitment into a guided internet based CBT (iCBT) intervention for depression: lesson learnt from the failure of a prevalence recruitment strategy. Contemp Clin Trials. 2011;32:641–8.PubMedCrossRef
9.
go back to reference Fairhurst K, Dowrick C. Problems with recruitment in a randomized controlled trial of counselling in general practice: causes and implications. J Health Serv Res Policy. 1996;1(2):77–80.PubMedCrossRef Fairhurst K, Dowrick C. Problems with recruitment in a randomized controlled trial of counselling in general practice: causes and implications. J Health Serv Res Policy. 1996;1(2):77–80.PubMedCrossRef
10.
go back to reference Rendell JM, Licht RW. Under-recruitment of patients for clinical trials: an illustrative example of a failed study. Acta Psychiatr Scand. 2007;115:337–9.PubMedCrossRef Rendell JM, Licht RW. Under-recruitment of patients for clinical trials: an illustrative example of a failed study. Acta Psychiatr Scand. 2007;115:337–9.PubMedCrossRef
11.
go back to reference Bower P, et al. Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities. Trials. 2014;15:399.PubMedPubMedCentralCrossRef Bower P, et al. Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities. Trials. 2014;15:399.PubMedPubMedCentralCrossRef
12.
go back to reference Hughes-Morley A, et al. Factors affecting recruitment into depression trials: systematic review meta-synthesis and conceptual framework. J Affect Disord. 2015;172:274–90.PubMedCrossRef Hughes-Morley A, et al. Factors affecting recruitment into depression trials: systematic review meta-synthesis and conceptual framework. J Affect Disord. 2015;172:274–90.PubMedCrossRef
13.
go back to reference Mason V, et al. GPs’ experiences of primary care mental health research: a qualitative study of the barriers to recruitment. Fam Pract. 2007;24:518–25.PubMedCrossRef Mason V, et al. GPs’ experiences of primary care mental health research: a qualitative study of the barriers to recruitment. Fam Pract. 2007;24:518–25.PubMedCrossRef
14.
go back to reference Barnes M, et al. Exploring patients’ reasons for declining contact in a cognitive behavioural therapy randomised controlled trial in primary care. Br J Gen Pract. 2012;62:e371-7. Barnes M, et al. Exploring patients’ reasons for declining contact in a cognitive behavioural therapy randomised controlled trial in primary care. Br J Gen Pract. 2012;62:e371-7.
15.
go back to reference House J, et al. Male views on help-seeking for depression: a Q methodology study. Psychol Psychother Theory Res Pract. 2018;91(1):117–40.CrossRef House J, et al. Male views on help-seeking for depression: a Q methodology study. Psychol Psychother Theory Res Pract. 2018;91(1):117–40.CrossRef
16.
go back to reference Simmonds B, et al. Patients’ experiences of participating in a large-scale trial of cognitive behavioural therapy for depression: a mixed methods study. Fam Pract. 2013;30:705–11.PubMedCrossRef Simmonds B, et al. Patients’ experiences of participating in a large-scale trial of cognitive behavioural therapy for depression: a mixed methods study. Fam Pract. 2013;30:705–11.PubMedCrossRef
17.
go back to reference Tallon D, et al. Involving patients with depression in research: survey of patients’ attitudes to participation. Br J Gen Pract. 2011;61:e134-41. Tallon D, et al. Involving patients with depression in research: survey of patients’ attitudes to participation. Br J Gen Pract. 2011;61:e134-41.
19.
go back to reference Brenes GA, et al. Telephone-delivered cognitive behavioral therapy and telephone-delivered nondirective supportive therapy for rural older adults with generalized anxiety disorder: a randomized clinical trial. JAMA Psychiatry. 2015;72(10):1012–20.PubMedPubMedCentralCrossRef Brenes GA, et al. Telephone-delivered cognitive behavioral therapy and telephone-delivered nondirective supportive therapy for rural older adults with generalized anxiety disorder: a randomized clinical trial. JAMA Psychiatry. 2015;72(10):1012–20.PubMedPubMedCentralCrossRef
21.
go back to reference Watkins E, Elliott S, Stanhope N, Button J, Williams R, Brown JSL. Meeting the needs for psychological treatment of people with common mental disorders: an exploratory study. J Ment Health. 2000;9(4):445–56.CrossRef Watkins E, Elliott S, Stanhope N, Button J, Williams R, Brown JSL. Meeting the needs for psychological treatment of people with common mental disorders: an exploratory study. J Ment Health. 2000;9(4):445–56.CrossRef
22.
go back to reference Brown JSL, et al. Meeting the unmet need for depression services with psycho-educational self-confidence workshops: preliminary report. Br J Psychiatry. 2004;185:511–5.PubMedCrossRef Brown JSL, et al. Meeting the unmet need for depression services with psycho-educational self-confidence workshops: preliminary report. Br J Psychiatry. 2004;185:511–5.PubMedCrossRef
23.
go back to reference Beck AT, et al. Cognitive therapy of depression. New York: Guilford Press; 1979. Beck AT, et al. Cognitive therapy of depression. New York: Guilford Press; 1979.
24.
go back to reference Yalom ID. The theory and practice of group psychotherapy. New York: Basic Books; 1995. Yalom ID. The theory and practice of group psychotherapy. New York: Basic Books; 1995.
25.
go back to reference Brown JSL, et al. Can the effects of a 1-day CBT psychoeducational workshop on self-confidence be maintained after 2 years? A naturalistic study. Depress Anxiety. 2008;25:632–40.PubMedCrossRef Brown JSL, et al. Can the effects of a 1-day CBT psychoeducational workshop on self-confidence be maintained after 2 years? A naturalistic study. Depress Anxiety. 2008;25:632–40.PubMedCrossRef
26.
go back to reference Brown JSL, et al. Are self-referrers just the worried well? Soc Psychiatry Psychiatr Epidemiol. 2005;40(5):396–401.PubMedCrossRef Brown JSL, et al. Are self-referrers just the worried well? Soc Psychiatry Psychiatr Epidemiol. 2005;40(5):396–401.PubMedCrossRef
27.
go back to reference Brown JSL, et al. How equitable are psychological therapy services in South East London now? A comparison of referrals to a new psychological therapy services with participants in a psychiatric morbidity survey in the same London borough. Soc Psychiatry Psychiatr Epidemiol. 2014;49(12):1893–902.PubMedPubMedCentralCrossRef Brown JSL, et al. How equitable are psychological therapy services in South East London now? A comparison of referrals to a new psychological therapy services with participants in a psychiatric morbidity survey in the same London borough. Soc Psychiatry Psychiatr Epidemiol. 2014;49(12):1893–902.PubMedPubMedCentralCrossRef
28.
go back to reference Gask L, et al. Improving access to psychosocial interventions for common mental health problems in the United Kingdom: narrative review and development of a conceptual model for complex interventions. BMC Health Serv Res. 2012;12:249.PubMedPubMedCentralCrossRef Gask L, et al. Improving access to psychosocial interventions for common mental health problems in the United Kingdom: narrative review and development of a conceptual model for complex interventions. BMC Health Serv Res. 2012;12:249.PubMedPubMedCentralCrossRef
29.
go back to reference Bhui K, Bhugra D. Mental illness in Black and Asian ethnic minorities: pathways to care and outcomes. Adv Psychiatr Treat. 2002;8:26–33.CrossRef Bhui K, Bhugra D. Mental illness in Black and Asian ethnic minorities: pathways to care and outcomes. Adv Psychiatr Treat. 2002;8:26–33.CrossRef
30.
go back to reference Horrell L, et al. One-day CBT self-confidence workshops for people with depression: randomised controlled trial to assess clinical outcomes and investigate access by difficult to engage groups. Br J Psychiatry. 2014;204:222–33.PubMedCrossRef Horrell L, et al. One-day CBT self-confidence workshops for people with depression: randomised controlled trial to assess clinical outcomes and investigate access by difficult to engage groups. Br J Psychiatry. 2014;204:222–33.PubMedCrossRef
31.
go back to reference Elliott S, Brown JSL. What are we doing to waiting list controls? Behav Res Ther. 2002;40:1047–52.PubMedCrossRef Elliott S, Brown JSL. What are we doing to waiting list controls? Behav Res Ther. 2002;40:1047–52.PubMedCrossRef
32.
33.
go back to reference Gilbody S, et al. Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial. BMJ. 2015;351:h5627. Gilbody S, et al. Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial. BMJ. 2015;351:h5627.
34.
go back to reference Wiles N, et al. Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial. Lancet. 2013;381(9864):375–84.PubMedCrossRef Wiles N, et al. Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial. Lancet. 2013;381(9864):375–84.PubMedCrossRef
35.
36.
go back to reference Tinning L, Harman K, Lee R, Brown JSL. Developing an accessible and effective public mental health programme for members of the general public. J Public Ment Health. 2009;8(2):26–35.CrossRef Tinning L, Harman K, Lee R, Brown JSL. Developing an accessible and effective public mental health programme for members of the general public. J Public Ment Health. 2009;8(2):26–35.CrossRef
37.
go back to reference Chan A-W, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. Chan A-W, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
39.
go back to reference Grimes DA, et al. The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet. 2005;366(9480):172–4.PubMedCrossRef Grimes DA, et al. The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet. 2005;366(9480):172–4.PubMedCrossRef
41.
go back to reference Brown JSL, Cochrane R, Cardone D. Large-scale health promotion stress workshops: promotion, programme content and client response. J Ment Health. 1999;8(4):391–402.CrossRef Brown JSL, Cochrane R, Cardone D. Large-scale health promotion stress workshops: promotion, programme content and client response. J Ment Health. 1999;8(4):391–402.CrossRef
Metadata
Title
How can we successfully recruit depressed people? Lessons learned in recruiting depressed participants to a multi-site trial of a brief depression intervention (the ‘CLASSIC’ trial)
Authors
June S. L. Brown
Caroline Murphy
Joanna Kelly
Kimberley Goldsmith
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-3033-5

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue