Community Outpatient Psychotherapy Engagement Service for Self-harm

NCT04191122 | Unknown

• 1 other identifier: NIHR200543
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Self-Harm; Depression

Keywords

Primary care; Community settings

Outcome Measures

Primary Outcomes (3)

• Acceptability of the intervention assessed by the number of therapy sessions completed by participants in the intervention arm.

  The proportion of patients who complete all agreed sessions of therapy will be recorded (\> 60% excellent. 40-60% acceptable; less than 40% not acceptable). Analysis of data from semi-structured interviews with participants, who did and did not complete the therapy, and therapists who delivered the therapy.

  2 years

• Incidence of Treatment-Emergent Adverse Events as assessed by the adverse experiences in psychotherapy self-reported measure

  The Adverse Experiences in Psychotherapy (AEP) self-report measure will identify adverse experiences liable to occur within psychological therapy. Safety will be assessed as part of routine monitoring of Serious Adverse Events (SAEs). Hospitalisation for any reason, medically serious acts of SH and suicidal crises (defined as participant having a plan and intent to make an imminent suicide attempt) will be regarded as SAEs. Where these occur, a review will take place to assess the plausibility of the SAE being due to the intervention. The occurrence of SAE and the results of the review process will be documented. In cases where SAE are potentially linked to the trial, withdrawal of participants, halting or terminating the trial will be considered as required.

  2 years

• Feasibility of the intervention assessed by the number of assessments completed by participants in the intervention arm

  We will collect data on the amount of missing data on completed assessments

  2 years

Secondary Outcomes (8)

• Beck Depression Inventory-II: Depressive symptoms

  2 years

• Frequency and severity of self-harm ideation and behaviour using the Self-Injurious Thoughts and Behaviours Interview - short form (SITBI) which is a structured interview

  2 years

• Frequency and intensity of SH urges over the preceding week using the Alexian Brothers Urge to Self-Injure Scale (ABUSI) to assess the frequency, intensity, and duration of the urge to self-injure.

  2 years

• Emotion regulation will be measured using the emotion regulation questionnaire that consists of 10 items capturing two specific emotion regulation strategies, cognitive reappraisal and expressive suppression.

  2 years

• Clinical Outcomes in Routine Evaluation (CORE-10)

  2 years

Study Arms (2)

COPESS and Treatment as usual

ACTIVE COMPARATOR

COPES is a brief (4 + 1 sessions, 50 minutes) psychotherapy based on psychodynamic and cognitive analytic principles that was developed to help those struggling with SH and depression. COPES is designed to be brief and accessible, and involves working collaboratively with a client to try and identify patterns or conflicts in emotional experiences and interpersonal relationships, linked to depressed mood and acts of SH. The therapist works with the client to build a shared map or understanding of these experiences. A goal of therapy is to work towards a small number of specific "exits", representing helpful steps the client might make to improve their difficulties. Therapy would take place either in the participant's home or in a community setting (e.g. health centre or clinic) depending on preference. Safety for the therapist and/or mobility for the patient will be reviewed throughout the recruitment period. Participants in the COPES arm of the trial will also receive TAU.

Other: COPESS

Treatment as usual only

NO INTERVENTION

The control group will receive Treatment-as usual (TAU), defined as the standard care provided to individuals struggling with self-harm (SH) as detailed within the 'Managing SH in primary care' NICE guidelines. These include: an initial comprehensive psychosocial assessment of skills and risks; co-production of a care and risk management care plan, which should include harm reduction plans, the need for between 3 and 12 sessions of psychological intervention as well as treatment for associated mental health conditions. Primary care practices in the control arm will be asked to provide information on what constitutes TAU within their organisation. This trial may enhance TAU as researchers will provide details of NICE guidance to GP practices that may not currently be following these guidelines. We will collect data regarding the acceptability of TAU for SH offered by GPs within both treatment arms.

Interventions

COPESS OTHER

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

Also known as: Community Outpatients Psychotherapy Engagement Service for Self-harm

COPESS and Treatment as usual

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent episode of SH (in the past six months, self-reported)
• A score of 14 or greater on the Beck Depression Inventory-II (BDI-II) corresponding to the BDI-II score where 14-19 = mild depression, 20-28 = moderate depression, \>28 = severe depression
• Aged 16 years and over (SH is especially prevalent in adolescents and young adults and often this transitional age is neglected. This study will be offering at least TAU which young people may not otherwise access. To leave 16-18 year olds out of this study may be unethical and guidance from the British Psychological Society states that people aged 16 years and over can give informed consent)
• Help-seeking, defined as attendance at GP practices or self-referral into the trial

You may not qualify if:

• Non-English speaking
• Diagnosed with an intellectual disability as determined by review of clinical notes - the therapy has not yet been adapted for working with this population
• Experiencing severe problems with addiction to alcohol or illicit drugs
• Actively suicidal or psychotic and/or severely depressed and unresponsive to treatment as judged by clinical team
• Unable or unwilling to give written informed consent to participate in the study
• Currently receiving talking therapy for SH

Sponsors & Collaborators

• Liverpool John Moores University: lead
• University of Liverpool: collaborator
• University of Manchester: collaborator
• University of Leeds: collaborator

Study Sites (1)

Brownlow Medical Group

Liverpool, United Kingdom

RECRUITING

Related Publications (3)

• Saini P, Hunt A, Clements C, Gabbay M, Mills C, Kvamme-Mitchell K, Tahir N, Mulholland H, Kullu C, Hann M, Duarte R, Murphy A, Guthrie E, Taylor P. Feasibility and acceptability of the Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS): randomised controlled trial. BJPsych Open. 2025 Aug 20;11(5):e190. doi: 10.1192/bjo.2025.10780.

  PMID: 40831028 DERIVED

• Saini P, Hunt A, Taylor P, Mills C, Clements C, Mulholland H, Kullu C, Hann M, Duarte R, Mattocks F, Guthrie E, Gabbay M. Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS): a feasibility trial protocol. Pilot Feasibility Stud. 2021 Aug 27;7(1):165. doi: 10.1186/s40814-021-00902-3.

  PMID: 34452642 DERIVED

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

  PMID: 33884617 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Pooja Saini, PhD

  Liverpool John Moores University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pooja Saini, PhD

CONTACT

01512318121; poojasaini@hotmail.co.uk

Pauline Parker

CONTACT

Pauline.parker@merseycare.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will be randomized to receive COPES plus TAU or TAU via a random sequence generation computer algorithm within STATA to generate (stratified) randomised (block) allocations. Randomisation will be carried out by the study statistician using an independent computerised randomisation system with a randomly sized block design with block sizes of 2, 4 and 6. The study population will be stratified for those receiving TAU and those receiving COPES plus TAU. Researchers completing study assessments will be masked to treatment allocation, facilitated by briefing members of the research team and participants on the need to avoid disclosure of treatment details. The trial will follow an Intent-To-Treat (ITT) protocol. Attrition and reasons for drop-out will be recorded where possible. Guidance will be sought from the patient advisory group on how to manage and minimise attrition over the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: COPES is a brief (4 + 1 sessions, 50 minutes) psychotherapy based on psychodynamic and cognitive analytic principles that was developed to help those struggling with SH and depression. COPES is designed to be brief and accessible and involves working collaboratively with a client to try and identify patterns or conflicts in emotional experiences and interpersonal relationships, linked to depressed mood and acts of SH. The therapist works with the client to build a shared map or understanding of these experiences. A goal of therapy is to work towards a small number of specific "exits", representing helpful steps the client might make to improve their difficulties. Therapy would take place either in the participant's home or in a community setting (e.g. health centre or clinic) depending on preference. Safety for the therapist and/or mobility for the patient will be reviewed throughout the recruitment period. Participants in the COPES arm of the trial will also receive TAU.

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: December 9, 2019
• Study Start: October 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: August 31, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)