Community Outpatient Psychotherapy Engagement Service for Self-harm

Depression Clinical Trial

— COPESS  

Official title:

Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS): A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04191122
• Other study ID #: NIHR200543
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: April 2022
• Source: Liverpool John Moores University
• Contact: Pooja Saini, PhD
• Phone: 01512318121
• Email: poojasaini[@]hotmail.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Self-Harm
• Self-Injurious Behavior

Intervention

Other:
• COPESS
The intervention includes brief psychotherapy to be delivered within primary care settings

Locations

Country	Name	City	State
United Kingdom	Brownlow Medical Group	Liverpool

Sponsors (4)

Lead Sponsor	Collaborator
Liverpool John Moores University	University of Leeds, University of Liverpool, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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	2 years
Secondary	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	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	Demographic characteristics	Age, sex, ethnicity, education, employment, social deprivation, and clinical history will be recorded at baseline.	2 years