Abstract
BackgroundSelf-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.MethodsSingle-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.ResultsTwenty-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.ConclusionsRCTs 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 registrationClinicalTrials.gov (NCT02377011); Date of registration: March 3rd 2015. Retrospectively registered: within 21 days of recruitment of the first participant.
Highlights
There are strong associations between self-harm and depressed mood and both are significant risk factors for suicide [1,2,3,4]
Since problem-solving therapy (PST) and cognitive behaviour therapy (CBT) are effective for depression [9], an intervention focussed on people with at least one previous self-harm episode and mild-moderate depression symptoms could be considered to be a clinical priority, given limited resources to offer such treatment to everyone who is assessed for self-harm
An randomised controlled trial (RCT) of a mobile phone intervention delivering PST, meditation, increased social support and advice on alcohol consumption to people recruited after self-harm reduced suicidal ideation and depression symptoms over 12 months, compared with usual care [17]
Summary
There are strong associations between self-harm and depressed mood and both are significant risk factors for suicide [1,2,3,4]. A Cochrane review of 55 RCTs involving 17,699 participants confirmed that PST and cognitive behaviour therapy (CBT) were effective in reducing the proportion experiencing repeat self-harm, suicidal ideation, depression symptoms and hopelessness over 12 months [8]. An RCT of a mobile phone intervention delivering PST, meditation, increased social support and advice on alcohol consumption to people recruited after self-harm reduced suicidal ideation and depression symptoms over 12 months, compared with usual care [17]. 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
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