Journal Article

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)

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

2019

Overview

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. Trial registration ClinicalTrials.gov ( NCT02377011 ); Date of registration: March 3rd 2015. Retrospectively registered: within 21 days of recruitment of the first participant.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / Adult / Analysis / Behavior modification / Behavioral medicine / Care and treatment / Clinical trials / Cognitive ability / Cognitive behavioral therapy / Cognitive Behavioral Therapy - methods / Cognitive behaviour therapy / Cognitive therapy / Depression / Depression (Mood disorder) / Depression - epidemiology / Depression - psychology / Depression - therapy / Evidence-based medicine / Feasibility Studies / Female / Follow-Up Studies / Humans / Male / Medicine / Medicine & Public Health / Mental depression / Mental disorders / Mental health services / Mood disorders / Pilot Projects / Problem Solving / Problem-solving therapy / Psychiatry / Psychological aspects / Psychotherapy / RCT / Research Article / Risk factors / Self destructive behavior / Self-harm / Self-Injurious Behavior - epidemiology / Self-Injurious Behavior - psychology / Self-Injurious Behavior - therapy / Self-injury / Single-Blind Method / Suicide / Suicide - prevention & control / Suicide - psychology / Suicides & suicide attempts / Teenagers / Telemedicine - methods / Young Adult / Young adults