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Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS)

Primary Purpose

Self-Harm, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
COPESS
Sponsored by
Liverpool John Moores University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self-Harm focused on measuring Primary care, Community settings

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Brownlow Medical GroupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

COPESS and Treatment as usual

Treatment as usual only

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Beck Depression Inventory-II: Depressive symptoms
Beck Depression Inventory-II - corresponding to the BDI-II score where 14-19 = mild depression, 20-28 = moderate depression, >28 = severe depression
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
Self-Injurious Thoughts and Behaviours Interview includes both quantitative and qualitative items that assess the presence, frequency, and characteristics of a wide range of self-injurious thoughts and behaviours, including suicidal ideation, suicide plans, suicide gestures, suicide attempts, and nonsuicidal self-injury
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.
Alexian Brothers Urge to Self-Injure Scale (ABUSI) is a uni-dimensional measure of the severity of the urge to self-injure and demonstrates high internal consistency and test-retest reliability. Responses are on a 7-point scale with a maximum total score of 30 and higher scores reflecting more intense urges to self-injure.
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.
The Emotion Regulation Questionnaire uses a 7-point Likert scale, where 1 means "strongly disagree", 4 "neutral", and 7 means "strongly agree". The higher the scores the greater the use of the emotion regulation strategy.
Clinical Outcomes in Routine Evaluation (CORE-10)
Clinical Outcomes in Routine Evaluation that is used within clinical health settings. The measure has 6 high intensity/severity and 4 low intensity/severity items. Higher scores indicate higher levels of general psychological distress, where a total score of 11 or above is within the clinically significant range and scores above 13 likely indicated depression.
Help-seeking questionnaires using the The General Help-Seeking Questionnaire (GHSQ) and The Actual Help Seeking Questionnaire (AHSQ) to assess intentions to seek help from different sources and for different problems.
The General Help-Seeking Questionnaire (GHSQ) and The Actual Help Seeking Questionnaire (AHSQ). For these measures participants respond to each problem-type by rating their help-seeking intentions on a 7-point scale ranging from 1 ("extremely unlikely") to 7 ("extremely likely") for each help source option including "no one." Higher scores indicate higher intentions.
The Helping Relationship Questionnaire (HRQ) measures the patient's perspective of the therapist-patient relationship via an 11 self-report items.
Items for the HRQ are rated on a 6-point likert scale, ranging from -3 ("Strongly feel it is not true") to +3 ("Strongly feel it is true"). Total scores, computed by summing all items, range from -33 to 33, with higher total scores reflecting greater therapeutic alliance.
Demographic characteristics
Age, sex, ethnicity, education, employment, social deprivation, and clinical history will be recorded at baseline.

Full Information

First Posted
November 5, 2019
Last Updated
April 5, 2022
Sponsor
Liverpool John Moores University
Collaborators
University of Liverpool, University of Manchester, University of Leeds
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1. Study Identification

Unique Protocol Identification Number
NCT04191122
Brief Title
Community Outpatient Psychotherapy Engagement Service for Self-harm
Acronym
COPESS
Official Title
Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS): A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool John Moores University
Collaborators
University of Liverpool, University of Manchester, University of Leeds

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Design A mixed-method evaluation of a single-blind randomised controlled trial (RCT) will determine the acceptability and safety of the COPES intervention, in preparation for a future large-scale trial of the efficacy of COPES for depression in people who SH. People who have depression and SH in the community will be randomised to receive either COPES plus treatment-as-usual (TAU) or TAU alone. Recruitment rates and power calculations This study is intended as a preliminary evaluation of the feasibility of conducting a future large-scale RCT of the COPES intervention. As, the investigators are not conducting any hypothesis testing of effectiveness, or estimation of prevalence (other than attrition) a formal power calculation is not appropriate. A recruitment target of n=60 (n=30 per trial arm) will be used. This is a common and realistic recruitment target for feasibility trials, and will allow adequate precision in estimating rates relevant to trial outcomes (e.g. attrition, adverse events). This will allow an overall attrition rate of 30% to be estimated with 95% confidence intervals of +/- 12% or, 16% for a single arm. This sample size is adequate for estimating relevant analysis parameters, such as the standard deviation of effects, which are needed for determining the feasibility of a later efficacy trial. To avoid high attrition rates, the investigators will keep participants engaged via text and/or telephone reminders. The previous pilot of HOPE within the ED achieved an average recruitment of nine eligible referrals each month. Sixty-one percent of participants engaged with the therapy and attended at least one session. Rates of attendance for SH at GP practices and walk-in centres in the Liverpool area have been estimated at 70 per month. Based on these figures a recruitment rate of 3 to 4 participants each month with a goal of n=60 participants overall is achievable. Research Sites The research will take place in Liverpool, in the North West of England. The North West has particularly high rates of SH. Between April 2011 and March 2014, there were 16,405 presentations for deliberate SH to emergency departments within Merseyside and Cheshire. Liverpool local authority had one of the highest number of attendances for SH in this area (15%, n = 2,489). Therefore, Liverpool provides a good location for undertaking work on SH. Recruitment of GP Practices Lead GPs and/or practice managers at practices identified as suitable for inclusion in the COPES study will be invited to take part in writing. Invitation packs will be given by GPs and followed up by a telephone/skype/face time/face-to-face contact from a member of the research team to ascertain level of interest, and if appropriate, to arrange a meeting to discuss the study in more detail. The Clinical Research Network (CRN) will assist with recruitment of GP practices and have provided a letter of support (see Appendix B). Clinicians will be briefed on the COPES trial and provided with guidance on referring patients in to the study. To assist recruitment, clinicians will be provided with a brief screening checklist to help identify patients where depression-linked SH may be a concern.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-Harm, Depression
Keywords
Primary care, Community settings

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COPESS and Treatment as usual
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment as usual only
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
COPESS
Other Intervention Name(s)
Community Outpatients Psychotherapy Engagement Service for Self-harm
Intervention Description
The intervention includes brief psychotherapy to be delivered within primary care settings
Primary Outcome Measure Information:
Title
Acceptability of the intervention assessed by the number of therapy sessions completed by participants in the intervention arm.
Description
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.
Time Frame
2 years
Title
Incidence of Treatment-Emergent Adverse Events as assessed by the adverse experiences in psychotherapy self-reported measure
Description
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.
Time Frame
2 years
Title
Feasibility of the intervention assessed by the number of assessments completed by participants in the intervention arm
Description
We will collect data on the amount of missing data on completed assessments
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Beck Depression Inventory-II: Depressive symptoms
Description
Beck Depression Inventory-II - corresponding to the BDI-II score where 14-19 = mild depression, 20-28 = moderate depression, >28 = severe depression
Time Frame
2 years
Title
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
Description
Self-Injurious Thoughts and Behaviours Interview includes both quantitative and qualitative items that assess the presence, frequency, and characteristics of a wide range of self-injurious thoughts and behaviours, including suicidal ideation, suicide plans, suicide gestures, suicide attempts, and nonsuicidal self-injury
Time Frame
2 years
Title
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.
Description
Alexian Brothers Urge to Self-Injure Scale (ABUSI) is a uni-dimensional measure of the severity of the urge to self-injure and demonstrates high internal consistency and test-retest reliability. Responses are on a 7-point scale with a maximum total score of 30 and higher scores reflecting more intense urges to self-injure.
Time Frame
2 years
Title
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.
Description
The Emotion Regulation Questionnaire uses a 7-point Likert scale, where 1 means "strongly disagree", 4 "neutral", and 7 means "strongly agree". The higher the scores the greater the use of the emotion regulation strategy.
Time Frame
2 years
Title
Clinical Outcomes in Routine Evaluation (CORE-10)
Description
Clinical Outcomes in Routine Evaluation that is used within clinical health settings. The measure has 6 high intensity/severity and 4 low intensity/severity items. Higher scores indicate higher levels of general psychological distress, where a total score of 11 or above is within the clinically significant range and scores above 13 likely indicated depression.
Time Frame
2 years
Title
Help-seeking questionnaires using the The General Help-Seeking Questionnaire (GHSQ) and The Actual Help Seeking Questionnaire (AHSQ) to assess intentions to seek help from different sources and for different problems.
Description
The General Help-Seeking Questionnaire (GHSQ) and The Actual Help Seeking Questionnaire (AHSQ). For these measures participants respond to each problem-type by rating their help-seeking intentions on a 7-point scale ranging from 1 ("extremely unlikely") to 7 ("extremely likely") for each help source option including "no one." Higher scores indicate higher intentions.
Time Frame
2 years
Title
The Helping Relationship Questionnaire (HRQ) measures the patient's perspective of the therapist-patient relationship via an 11 self-report items.
Description
Items for the HRQ are rated on a 6-point likert scale, ranging from -3 ("Strongly feel it is not true") to +3 ("Strongly feel it is true"). Total scores, computed by summing all items, range from -33 to 33, with higher total scores reflecting greater therapeutic alliance.
Time Frame
2 years
Title
Demographic characteristics
Description
Age, sex, ethnicity, education, employment, social deprivation, and clinical history will be recorded at baseline.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pooja Saini, PhD
Phone
01512318121
Email
poojasaini@hotmail.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline Parker
Email
Pauline.parker@merseycare.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pooja Saini, PhD
Organizational Affiliation
Liverpool John Moores University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brownlow Medical Group
City
Liverpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Exley
Email
Diane.Exley@livgp.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No need to make data available to other researchers
Citations:
PubMed Identifier
34452642
Citation
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.
Results Reference
derived
PubMed Identifier
33884617
Citation
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.
Results Reference
derived

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Community Outpatient Psychotherapy Engagement Service for Self-harm

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