Community Outpatient Psychotherapy Engagement Service for Self-harm

NCT04191122 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-04-06

No results posted yet for this study

Summary

Background: Self-harm (SH) is any act of intentional self-injury or self-poisoning, with or without the intention to die. People who SH are at high risk for future suicide and often suffer considerable emotional distress. Depression is common among people who SH and may be an underlying driver of self-harm behaviour. Treating depression in people who SH has the potential to reduce the risk of further SH and suicide. 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 SH, but further evaluation of these approaches is needed. The Community Outpatient Psychological Engagement Service for Self-Harm (COPESS) is a brief talking therapy intervention for depression and self-harm. This intervention was shown to be feasible and acceptable in hospital emergency department settings, but accessibility was limited; thus, the investigators wish to develop and test a community-based version of this intervention. The COPESS project moves this therapy into a community setting, thereby increasing the number of people who can be helped, especially those in hard-to-reach groups and from disadvantaged areas.

Aim: To assess the feasibility of conducting a trial of the COPESS intervention in a community setting, for people with depression who self-harm, in relation to participant recruitment and retention. Therapy, acceptability and safety of the intervention will also be assessed.

Methods: Using a Single Blind Randomised Control Trial (RCT) design, the investigators will recruit a sample of n=60 participants with a history of SH within the last six months, who are also currently depressed. Recruitment will take place via GP practices for patients who: 1) seek consultation for self-harm; 2) have consulted for self-harm in the previous 6 months (determined by GPs' search of their own data-systems); or 3) self-refer via their GP. Following baseline assessment participants will be randomly allocated to either receive COPESS plus Treatment as Usual \[TAU; n = 30)\] or TAU alone (n=30). Follow-up assessments will take place at one, two and three months. Recruitment rates, attrition and data completeness will be monitored. Qualitative interviews with participants and stakeholders will further investigate feasibility.

Conditions

Interventions

OTHER

COPESS

The intervention includes brief psychotherapy to be delivered within primary care settings

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER
  • University of Manchester

    collaborator OTHER
  • University of Leeds

    collaborator OTHER
  • Liverpool John Moores University

    lead OTHER

Principal Investigators

  • Pooja Saini, PhD · Liverpool John Moores University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-07-31
Completion
2022-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04191122 on ClinicalTrials.gov