Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS): a feasibility trial protocol.
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ABSTRACT: Background
People who self-harm are at high risk for future suicide and often suffer considerable emotional distress. Depression is common among people who self-harm and may be an underlying driver of self-harm behaviour. 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 self-harm, but further evaluation of these approaches is needed. A brief talking therapy intervention for depression and self-harm has been designed for use in a community setting. This mixed methods feasibility study with repeated measures will examine the feasibility and acceptability of the Community Outpatient Psychological Engagement Service for Self-Harm (COPESS) for people with self-harm and depression in the community, compared to routine care.Methods
Sixty participants with a history of self-harm within the last six months, who are also currently depressed, will be recruited to take part in a feasibility single-blind randomised controlled trial (RCT). Participants will be randomised 1:1 to receive COPESS plus treatment as usual (TAU) or TAU alone. Recruitment will be via General Practitioners (GP) and self-referral. Assessment of feasibility and acceptability will be assessed via quantitative and qualitative methods including measures of recruitment and retention to the feasibility trial, participants' experience of therapy, completion/completeness of outcome measures at relevant time-points and completion of a service use questionnaire.Discussion
The results will indicate whether it is feasible to conduct a definitive full trial to determine whether COPESS is a clinically and cost effective intervention for people who self-harm in the community. Qualitative and quantitative data will in addition help identify potential strengths and/or challenges of implementing brief community-based interventions for people who self-harm.Trial registration
NCT04191122 registered 9th December 2019.
SUBMITTER: Saini P
PROVIDER: S-EPMC8390538 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundHundreds of youth psychotherapy randomized trials have generated scores of helpful empirically supported treatments (ESTs). However, the standardized structure of many ESTs and their focus on a single disorder or homogeneous cluster of problems may not be ideal for clinically referred youths who have comorbidity and whose treatment needs may shift from week to week. This concern has prompted development of flexible transdiagnostic, modular youth psychotherapies. One of these, designed for efficient training and implementation, is FIRST-a transdiagnostic intervention built on five empirically supported principles of change (i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, and trying the opposite) and targeting common internalizing and externalizing youth mental health disorders and problems. FIRST has shown promise in improving youth mental health in three open trials. Now, in a more rigorous test, we seek to (1) conduct a randomized controlled trial comparing FIRST to usual care in real-world clinical practice settings; (2) examine a promising candidate mediator of change-regulation of negative emotions; and (3) explore variables that may influence clinicians' treatment implementation.MethodsThis is an assessor-naïve randomized controlled effectiveness trial in youth outpatient community clinics in New England and Texas. Using double randomization, clinic-employed clinicians and treatment-referred youths (7-15 years old) are independently randomly allocated (1:1) to FIRST or usual care. We aim to recruit 212 youth participants, all referred through normal community pathways, with elevated symptoms of anxiety, depression, conduct problems, or post-traumatic stress. This study will test the effectiveness of FIRST compared to usual care on mental health outcomes, examine whether those outcomes are mediated by regulation of negative emotions, and explore clinician factors that may be associated with FIRST implementation and outcomes. Session recordings are coded to assess treatment fidelity.DiscussionThis study will evaluate the effectiveness of FIRST in youth community mental health settings, relative to the care usually provided in those settings. If FIRST is found to be effective, it could offer an efficient and practical method to increase use of empirically supported treatment principles in real-world practice contexts.Trial registrationNIH Clinical Trials Registry, NCT04725721. Registered 27 January 2021, https://clinicaltrials.gov/ct2/show/study/NCT04725721.
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Project description:BackgroundHundreds of youth psychotherapy randomized trials have generated scores of helpful empirically supported treatments (ESTs). However, the standardized structure of many ESTs and their focus on a single disorder or homogeneous cluster of problems may not be ideal for clinically referred youths who have comorbidity and whose treatment needs may shift from week to week. This concern has prompted development of flexible transdiagnostic, modular youth psychotherapies. One of these, designed for efficient training and implementation, is FIRST-a transdiagnostic intervention built on five empirically supported principles of change (i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, and trying the opposite) and targeting common internalizing and externalizing youth mental health disorders and problems. FIRST has shown promise in improving youth mental health in three open trials. Now, in a more rigorous test, we seek to (1) conduct a randomized controlled trial comparing FIRST to usual care in real-world clinical practice settings; (2) examine a promising candidate mediator of change-regulation of negative emotions; and (3) explore variables that may influence clinicians' treatment implementation.MethodsThis is an assessor-naïve randomized controlled effectiveness trial in youth outpatient community clinics in New England and Texas. Using double randomization, clinic-employed clinicians and treatment-referred youths (7-15 years old) are independently randomly allocated (1:1) to FIRST or usual care. We aim to recruit 212 youth participants, all referred through normal community pathways, with elevated symptoms of anxiety, depression, conduct problems, or post-traumatic stress. This study will test the effectiveness of FIRST compared to usual care on mental health outcomes, examine whether those outcomes are mediated by regulation of negative emotions, and explore clinician factors that may be associated with FIRST implementation and outcomes. Session recordings are coded to assess treatment fidelity.DiscussionThis study will evaluate the effectiveness of FIRST in youth community mental health settings, relative to the care usually provided in those settings. If FIRST is found to be effective, it could offer an efficient and practical method to increase use of empirically supported treatment principles in real-world practice contexts.Trial registrationNIH Clinical Trials Registry, NCT04725721. Registered 27 January 2021, https://clinicaltrials.gov/ct2/show/study/NCT04725721.
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Project description:Transdiagnostic psychotherapeutic approaches are increasingly used in neurorehabilitation to address psychological distress. Animal-assistance is thought to increase efficacy. The present study evaluates a psychotherapeutic mindfulness- and self-compassion-based group intervention (MSCBI) with and without animal-assistance for patients with acquired brain injury. Patients (N = 31) were randomly assigned to the 6-week intervention with (n = 14) or without animal-assistance (n = 17). Primary outcome was psychological distress at post- and follow-up treatment, secondary outcomes were changes within-session of patients' emotional states, adherence to treatment and attrition. Psychological distress significantly decreased in both groups from pre- to follow-up treatment with no difference between groups. Patients in the animal-assisted MSCBI group reported significantly higher increases in feeling secure, accepted, comforted, grateful, motivated and at ease during the sessions compared to patients in the MSCBI group without animal-assistance. Adherence to sessions was significantly higher in the animal-assisted MSCBI group. Attrition did not significantly differ between groups. Our results show that both MSCBIs with and without animal-assistance are feasible and effective in reducing psychological distress in patients with acquired brain injury. The significant changes within-sessions mainly in relationship-based emotional states and the higher treatment adherence suggest additional effects of animal-assistance. Animal-assistance might increase acceptability and patients' commitment to psychotherapy.
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Project description:BackgroundService disengagement is a pervasive challenge the mental health care system faces. Mental health services are of little value should persons with mental illnesses continue to opt out of receiving them. Consumers attribute disengagement from care to an absence of choice in their treatment. In response, the mental health system is adopting a person-centered model, based upon recovery principles, to engage consumers more actively in their care. Person-centered care planning is a promising practice involving collaboration to develop and implement an actionable plan to assist the person in achieving personal recovery goals.Methods/designThis study design combines a parallel-group randomized controlled trial of community mental health organizations with qualitative methods to assess the effectiveness of person-centered care planning. Participants at 14 sites in Delaware and Connecticut will be randomized to treatment as usual or the person-centered care planning intervention. Participants will be in leadership (n = 70) or supervisory or direct care (n = 210) roles. The person-centered care planning intervention involves intensive staff training and 12 months of ongoing technical assistance. Quantitative survey data will be collected at baseline, 6 months and 12 months measuring person-centered care planning competency and organizational factors. Consumer outcomes (engagement, medication adherence, functioning and consumer satisfaction) will be assessed by Medicaid and state-level data. Qualitative data focused on process factors will include staff and consumer interviews and focus groups. In this intent-to-treat analysis, we will use mixed-effects multivariate regression models to evaluate the differential impact of the person-centered care planning intervention on each consumer and implementation outcome as well as the extent to which clinician assessments of organizational factors are associated with the implementation outcome. Mixed methods will triangulate and strengthen the interpretation of outcomes.DiscussionThe aim of this study is to generate valuable guidance for state systems engaged in scale-up and transformation efforts. Targeted staff selection for training to support sustainability will serve to provide further insight into important intervention implementation strategies. Person-centered care planning has the potential to enhance the impact of all evidence-based and recovery-oriented practices and bring practice into line with the emerging national guidelines in health care reform.Trial registrationThis trial was registered with ClinicalTrials.gov (Identifier: NCT02299492) on 21 November 2014 as New York University Protocol Record PCCP-13-9762, Person-Centered Care Planning and Service Engagement.
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Project description:IntroductionSelf-harm in prison is a major public health concern. Less than 5% of UK prisoners are women, but they carry out more than a fifth of prison self-harm. Scars resulting from self-harm can be traumatising and stigmatising, yet there has been little focus on recovery of women prisoners with self-harm scarring. Medical skin camouflage (MSC) clinics treat individuals with disfiguring skin conditions, with evidence of improved well-being, self-esteem and social interactions. Only one community study has piloted the use of MSC for self-harm scarring.Methods and analysisWe describe an acceptability and feasibility pilot randomised controlled trial; the first to examine MSC for women prisoners who self-harm. We aim to randomise 20-25 women prisoners to a 6-week MSC intervention and 20-25 to a waitlist control (to receive the MSC after the study period). We aim to train at least 6-10 long-term prisoners with personal experience of self-harm to deliver the intervention. Before and after intervention, we will pilot collection of women-centred outcomes, including quality of life, well-being and self-esteem. We will pilot collection of self-harm incidents during the intervention, resources used to manage/treat self-harm and follow-up of women at 12 weeks from baseline. Data on recruitment, retention and dropout will be recorded. We aim for the acceptability of the intervention to prison staff and women prisoners to be explored in qualitative interviews and focus groups.Ethics and disseminationEthical approval for COVER has been granted by the North East-York Research Ethics Committee (REC) for phases 1 and 2 (reference: 16/NE/0030) and West of Scotland REC 3 for phases 3 and 4 (reference: 16/WS/0155). Informed consent will be the primary consideration; it will be made clear that participation will have no effect on life in prison or eligibility for parole. Due to the nature of the study, disclosures of serious self-harm may need to be reported to prison officials. We aim for findings to be disseminated via events at the study prison, presentations at national/international conferences, journal publications, prison governor meetings and university/National Health Service trust communications.Trial registration numberNCT02638974; Pre-results.
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