TY - JOUR
T1 - Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS): A feasibility trial protocol
AU - Saini, Pooja
AU - Hunt, Anna
AU - Taylor, Peter
AU - Mills, Catherine
AU - Clements, Caroline
AU - Mulholland, Helen
AU - Kullu, Cecil
AU - Hann, Mark
AU - Duarte, Rui V.
AU - Mattocks, Felicity
AU - Guthrie, Else
AU - Gabbay, Mark
N1 - Funding Information:
This project is funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR200543). The funding body had no role in the design of the study or in writing this manuscript. The views expressed in this publication are those of the authors and not necessarily those of the National Institute for Health Research or of the Department of Health and Social Care.
Funding Information:
The authors would like to thank all of the Public and Patient Involvement representatives, Mersey Care Foundation Trust, Clive Turpin, the National Institute for Health Research and The Applied Research Collaboration North West Coast. Professor Mark Gabbay is part-funded by the National Institute for Health Research Applied Research Collaboration North West Coast (NIHR ARC NWC). Approved. Feasibility trial start was been delayed due to COVID-19, the intervention and data collection then adapted for the pandemic and commenced late 2020. This article describes protocol version 1.8 dated 18/09/2020; when all initial approvals (REC, HRA and IRAS) were received, the protocol was version 1.0 dated 06/12/2019
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/8/27
Y1 - 2021/8/27
N2 - Background: People who self-harm are at high risk for future suicide and often suffer considerable emotional distress. Depression is common among people who self-harm and may be an underlying driver of self-harm behaviour. Self-harm is often repeated, and risk of repetition is highest immediately after an act of self-harm. Readily accessible brief talking therapies show promise in helping people who self-harm, but further evaluation of these approaches is needed. A brief talking therapy intervention for depression and self-harm has been designed for use in a community setting. This mixed methods feasibility study with repeated measures will examine the feasibility and acceptability of the Community Outpatient Psychological Engagement Service for Self-Harm (COPESS) for people with self-harm and depression in the community, compared to routine care. Methods: Sixty participants with a history of self-harm within the last six months, who are also currently depressed, will be recruited to take part in a feasibility single-blind randomised controlled trial (RCT). Participants will be randomised 1:1 to receive COPESS plus treatment as usual (TAU) or TAU alone. Recruitment will be via General Practitioners (GP) and self-referral. Assessment of feasibility and acceptability will be assessed via quantitative and qualitative methods including measures of recruitment and retention to the feasibility trial, participants’ experience of therapy, completion/completeness of outcome measures at relevant time-points and completion of a service use questionnaire. Discussion: The results will indicate whether it is feasible to conduct a definitive full trial to determine whether COPESS is a clinically and cost effective intervention for people who self-harm in the community. Qualitative and quantitative data will in addition help identify potential strengths and/or challenges of implementing brief community-based interventions for people who self-harm. Trial registration: NCT04191122 registered 9th December 2019.
AB - Background: People who self-harm are at high risk for future suicide and often suffer considerable emotional distress. Depression is common among people who self-harm and may be an underlying driver of self-harm behaviour. Self-harm is often repeated, and risk of repetition is highest immediately after an act of self-harm. Readily accessible brief talking therapies show promise in helping people who self-harm, but further evaluation of these approaches is needed. A brief talking therapy intervention for depression and self-harm has been designed for use in a community setting. This mixed methods feasibility study with repeated measures will examine the feasibility and acceptability of the Community Outpatient Psychological Engagement Service for Self-Harm (COPESS) for people with self-harm and depression in the community, compared to routine care. Methods: Sixty participants with a history of self-harm within the last six months, who are also currently depressed, will be recruited to take part in a feasibility single-blind randomised controlled trial (RCT). Participants will be randomised 1:1 to receive COPESS plus treatment as usual (TAU) or TAU alone. Recruitment will be via General Practitioners (GP) and self-referral. Assessment of feasibility and acceptability will be assessed via quantitative and qualitative methods including measures of recruitment and retention to the feasibility trial, participants’ experience of therapy, completion/completeness of outcome measures at relevant time-points and completion of a service use questionnaire. Discussion: The results will indicate whether it is feasible to conduct a definitive full trial to determine whether COPESS is a clinically and cost effective intervention for people who self-harm in the community. Qualitative and quantitative data will in addition help identify potential strengths and/or challenges of implementing brief community-based interventions for people who self-harm. Trial registration: NCT04191122 registered 9th December 2019.
UR - http://www.scopus.com/inward/record.url?scp=85113478333&partnerID=8YFLogxK
U2 - 10.1186/s40814-021-00902-3
DO - 10.1186/s40814-021-00902-3
M3 - Article
VL - 7
JO - Pilot and Feasibility Studies
JF - Pilot and Feasibility Studies
IS - 1
M1 - 165
ER -
