Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: study protocol.

INTRODUCTION: A digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. This study aims to refine the programme based on user feedback, and to assess the acceptability and feasibility of the updated version and study methods. METHODS AND ANALYSIS: Initially, this study will refine MoodHwb with the involvement of young people, including in a pretrial acceptability phase. This will be followed by a multicentre feasibility randomised controlled trial comparing MoodHwb plus usual care with a digital information pack plus usual care. Up to 120 young people aged 13-19 years with symptoms of depression and their parents/carers will be recruited through schools, mental health services, youth services, charities and voluntary self-referral in Wales and Scotland. The primary outcomes are the feasibility and acceptability of the MoodHwb programme (including usage, design and content) and of trial methods (including recruitment and retention rates), assessed 2 months postrandomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, well-being and depression and anxiety symptoms measured at 2 months postrandomisation. ETHICS AND DISSEMINATION: The pretrial acceptability phase was approved by the Cardiff University School of Medicine Research Ethics Committee (REC) and the University of Glasgow College of Medicine, Veterinary and Life Sciences REC. The trial was approved by Wales NHS REC 3 (21/WA/0205), the Health Research Authority(HRA), Health and Care Research Wales (HCRW), university health board Research and Development (R&D) departments in Wales, and schools in Wales and Scotland. Findings will be disseminated in peer-reviewed open-access journals, at conferences and meetings, and online to academic, clinical, and educational audiences and the wider public. TRIAL REGISTRATION NUMBER: ISRCTN12437531.

SAFETEL: a pilot randomised controlled trial to assess the feasibility and acceptability of a safety planning and telephone follow-up intervention to reduce suicidal behaviour.

BACKGROUND: A previous suicide attempt is an important predictor of future suicide. However, there are no evidence-based interventions administered in UK general hospital contexts to reduce suicidal behaviour in patients admitted following a suicide attempt. Consequently, the objective of this pilot randomised controlled trial was to explore whether a safety planning and telephone follow-up intervention (SAFETEL) was feasible and acceptable for individuals treated in hospital following a suicide attempt. METHODS: In this three-phase study with an embedded process evaluation, a safety planning intervention was tailored to the UK context (Phase I), piloted (Phase II, n = 32), and tested in a feasibility randomised controlled trial (Phase III). In Phase III, participants were allocated to either the intervention (n = 80) or control group (n = 40) using telephone randomisation with a 2:1 ratio. The acceptability and feasibility of the trial and intervention procedures were evaluated using both qualitative (interviews and focus groups) and quantitative data. The number of hospital representations of suicidal behaviour was also collected 6 months after study recruitment based on electronic patient records. RESULTS: Findings indicated that SAFETEL was both acceptable and feasible. Hospital staff reported the intervention fitted and complemented existing services, and patients reported that they favoured the simplicity and person-centred approach of the safety planning intervention. CONCLUSIONS: All progression criteria were met supporting further evaluation of the intervention in a full-scale clinical effectiveness trial. TRIAL REGISTRATION: ISRCT, ISRCTN62181241 , 5/5/2017.

SAFETEL randomised controlled feasibility trial of a safety planning intervention with follow-up telephone contact to reduce suicidal behaviour: study protocol.

INTRODUCTION: There are no evidence-based interventions that can be administered in hospital settings following a general hospital admission after a suicide attempt. AIM: To determine whether a safety planning intervention (SPI) with follow-up telephone support (SAFETEL) is feasible and acceptable to patients admitted to UK hospitals following a suicide attempt. METHODS AND ANALYSIS: Three-phase development and feasibility study with embedded process evaluation. Phase I comprises tailoring an SPI with telephone follow-up originally designed for veterans in the USA, for use in the UK. Phase II involves piloting the intervention with patients (n=30) who have been hospitalised following a suicide attempt. Phase III is a feasibility randomised controlled trial of 120 patients who have been hospitalised following a suicide attempt with a 6-month follow-up. Phase III participants will be recruited from across four National Health Service hospitals in Scotland and randomised to receive either the SPI with telephone follow-up and treatment as usual (n=80) or treatment as usual only (n=40). The primary outcomes are feasibility outcomes and include the acceptability of the intervention to participants and intervention staff, the feasibility of delivery in this setting, recruitment, retention and intervention adherence as well as the feasibility of collecting the self-harm re-admission to hospital outcome data. Statistical analyses will include description of recruitment rates, intervention adherence/use, response rates and estimates of the primary outcome event rates, and intervention effect size (Phase III). Thematic analyses will be conducted on interview and focus group data. ETHICS AND DISSEMINATION: The East of Scotland Research Ethics Service (EoSRES) approved this study in March 2017 (GN17MH101 Ref: 17/ES/0036). The study results will be disseminated via peer-reviewed publication and conference presentations. A participant summary paper will also be disseminated to patients, service providers and policy makers alongside the main publication. TRIAL REGISTRATION NUMBER: ISRCTN62181241.