Self-HarmCOPESSNCT04191122
Community Outpatient Psychotherapy Engagement Service for Self-harm
A study testing COPESS in people with Self-Harm and Depression, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self-Harm, Depression
- What is being tested?
- COPESS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pauline Parker contact
United Kingdom1 site, 1 recruiting
- Recruiting
Brownlow Medical Group
Liverpool
Diane Exley, Diane.Exley@livgp.nhs.uk
About this study
Official title: Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS): A Feasibility Study
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.
Read the 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.
- Conditions
- Self-Harm, Depression
- Being tested
- COPESS
- Keywords
- Primary care, Community settings
- Medical subject headings
- Self-Injurious Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPESSOther
Also called Community Outpatients Psychotherapy Engagement Service for Self-harm
The intervention includes brief psychotherapy to be delivered within primary care settings
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 2 years
Secondary outcomes (8)
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
Measured: 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
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
Measured: 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.
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.
Measured: 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.
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Demographic characteristics
Age, sex, ethnicity, education, employment, social deprivation, and clinical history will be recorded at baseline.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Oct 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Self-HarmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, University of Manchester, University of Leeds
- Responsible party
- Principal investigator, Pooja Saini, Liverpool John Moores University
- Investigators
- Pooja Saini, PhD, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191122
- Sponsor's protocol ID
- NIHR200543
- Acronym
- COPESS
- Status last verified
- Apr 2022
- First submitted
- 5 Nov 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No need to make data available to other researchers
Publications
Clements C, Mulholland H, Hunt A, Mills C, Kvamme-Mitchell K, Tahir N, Kullu C, Taylor P, Gabbay M, Saini P. Exploring the acceptability of a brief, rapid-access, self-harm focussed talking therapy: a qualitative analysis of patient experiences. BMJ Open. 2026 Jun 3;16(6):e118241. doi: 10.1136/bmjopen-2026-118241.
PubMed 42236088Saini 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.
PubMed 40831028Saini 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.
PubMed 34452642Witt 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.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS): A Feasibility Study
- ClinicalTrials.gov ID
- NCT04191122
- Acronym / sponsor ID
- COPESS / NIHR200543
- Conditions
- Self-Harm, Depression
- Keywords
- Primary care, Community settings
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- University of Liverpool, University of Manchester, University of Leeds
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| COPESS and Treatment as usual | Active comparator | Other: COPESSCOPES 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. |
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPESSAlso: Community Outpatients Psychotherapy Engagement Service for Self-harmThe intervention includes brief psychotherapy to be delivered within primary care settings | Other | COPESS and Treatment as usual |
Primary outcome
Acceptability of the intervention assessed by the number of therapy sessions completed by participants in the intervention arm.
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
We will collect data on the amount of missing data on completed assessments
8 secondary outcomes
Beck Depression Inventory-II: Depressive symptoms
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Clinical Outcomes in Routine Evaluation (CORE-10)
Time frame: 2 years
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.
Time frame: 2 years
The Helping Relationship Questionnaire (HRQ) measures the patient's perspective of the therapist-patient relationship via an 11 self-report items.
Time frame: 2 years
Demographic characteristics
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 42236088Clements C, Mulholland H, Hunt A, Mills C, Kvamme-Mitchell K, Tahir N, Kullu C, Taylor P, Gabbay M, Saini P. Exploring the acceptability of a brief, rapid-access, self-harm focussed talking therapy: a qualitative analysis of patient experiences. BMJ Open. 2026 Jun 3;16(6):e118241. doi: 10.1136/bmjopen-2026-118241.
- Derived from this study: PubMed 40831028Saini 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.
- Derived from this study: PubMed 34452642Saini 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.
- Derived from this study: PubMed 33884617Witt 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.
- Individual participant dataSharing planned: No. No need to make data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline Parker contact
Pooja Saini, PhD principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPESS in people with Self-Harm and Depression, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pooja Saini, PhD (01512318121, poojasaini@hotmail.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the intervention assessed by the number of therapy sessions completed by participants in the intervention arm. (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04191122, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.