Feasibility of a randomised controlled trial of remotely delivered problem-solving cognitive behaviour therapy versus usual care for young people with depression and repeat self-harm: lessons learnt (e-DASH)

Sayal, Kapil; Roe, James; Ball, Harriet; Atha, Christopher; Kaylor-Hughes, Catherine; Guo, Boliang; Townsend, Ellen; Morriss, Richard

Abstract

Background

Self-harm and depression are strong risk factors for repeat self-harm and suicide. We aimed to investigate the feasibility of a randomised controlled trial (RCT) of remotely delivered problem-solving cognitive behaviour therapy (PSCBT) plus treatment as usual (TAU) versus TAU in young people with repeat self-harm and depression.

Methods

Single-blind multi-centre RCT with an internal pilot, pre-set stop-go criteria and qualitative semi-structured interviews. Eligible participants (aged 16–30 years) were recruited from 9 adult or child and adolescent self-harm and crisis services; had ≥ 2 lifetime self-harm episodes, one in the preceding 96 h; and Beck Depression Inventory-II (BDI-II) score ≥ 17. Participants were randomised (1:1) to either TAU or TAU and 10–12 sessions of PSCBT delivered by mobile phone or video-calling.

Results

Twenty-two participants were recruited (11 in each arm), 10 (46%) completed follow-up at 6 months, 9 (82%) started the PSCBT and 4 (36%) completed it. The study did not meet three of its four stop-go criteria, reflecting considerable barriers to recruitment and retention. Participants had severe depression symptoms: with mean BDI-II 38.9 in the PSCBT and 37.2 in TAU groups, respectively. Three (14%) unblindings occurred for immediate safety concerns. Barriers to recruitment and retention included lack of agency for participants, severity of depression, recency of crisis with burden for participants and clinicians who diagnosed depression according to pervasiveness.

Conclusions

RCTs of PSCBT for young people with depression and self-harm are not feasible using recruitment through mental health services that conduct assessments following self-harm presentations. Clinician assessment following self-harm presentation mainly identifies those with severe rather than mild-moderate depression.

Citation

Sayal, K., Roe, J., Ball, H., Atha, C., Kaylor-Hughes, C., Guo, B., Townsend, E., & Morriss, R. (2019). Feasibility of a randomised controlled trial of remotely delivered problem-solving cognitive behaviour therapy versus usual care for young people with depression and repeat self-harm: lessons learnt (e-DASH). BMC Psychiatry, 19(1), Article 42. https://doi.org/10.1186/s12888-018-2005-3

• Journal Article Type: Article
• Acceptance Date: Dec 27, 2018
• Online Publication Date: Jan 24, 2019
• Publication Date: 2019-12
• Deposit Date: Jan 29, 2019
• Publicly Available Date: Jan 29, 2019
• Journal: BMC Psychiatry
• Electronic ISSN: 1471-244X
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 19
• Issue: 1
• Article Number: 42
• DOI: https://doi.org/10.1186/s12888-018-2005-3
• Keywords: Psychiatry and Mental health
• Public URL: https://nottingham-repository.worktribe.com/output/1504366
• Publisher URL: https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-018-2005-3
• Additional Information: Received: 3 August 2018; Accepted: 27 December 2018; First Online: 24 January 2019; : Ethics approval was obtained from the National Research Ethics Service (NRES) Committee East Midlands - Nottingham 1, UK on 24th September 2014 (REC reference: 14/EM/1084). All participants provided written informed consent. The consent included contact details of up to three family or close friend contacts that a participant was willing to give to the research team if there were safety concerns.; : Not applicable; : The authors declare that they have no competing interests.; : Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
• Contract Date: Jan 29, 2019