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Feasibility trial of support and skills course for mental health carers

A feasibility trial of a skills enhancing programme for carers of people presenting with complex emotional needs and/or chronic emotion dysregulation – Carers All Require Emotional support, Resilience and Skills: the CARERS trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16347322
Enrollment
96
Registered
2024-07-08
Start date
2024-07-15
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex emotional needs and/or chronic emotion dysregulation Mental and Behavioural Disorders

Interventions

We will randomise carers (and their associated service user) to either the intervention group or a control group. Carers in the intervention group will receive the 12-week ‘Family Connections’ (FC) co
it's impact on their lives
positive and negative aspects of the course
and potential benefits for service users. Course facilitators will be interviewed abou

Sponsors

University of York
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Potential carer participants must satisfy the following criteria to be enrolled in this study: 1. Adults aged >=18 years 2. Self- or service user-identified carer or support person. We recognise that the identification and recording of carers in patient records is not routine and we will explore the best identification mechanisms during the study 3. Willing to attend Family Connections groups 4. Willing to provide written, informed consent to take part 5. Access to PC/laptop/smartphone and good quality internet for the purpose of completing the intervention sessions as well as completing questionnaires and possible qualitative interviews online 6. Has not attended and completed Family Connections sessions previously Potential service user participants must satisfy the following criteria to be enrolled in this study: 1. Adults aged >=18 years 2. Presenting with complex emotional needs and chronic emotion dysregulation, and/or a clinical diagnosis of borderline personality disorder or emotionally unstable personality disorder 3. Competent and willing to provide written, informed consent to take part 4. Access to PC/laptop/smartphone and good quality internet for the purpose of completing questionnaires and possible qualitative interviews online

Exclusion criteria

Exclusion criteria: Literacy levels such that the study materials are inaccessible. This will be established through discussion with the service user’s care coordinator during the eligibility assessment. Given this is a feasibility study the researchers will not have the resources to support non-English literacy/speaking participants.

Design outcomes

Primary

MeasureTime frame
Feasibility outcome: Number of eligible carers and service users recruited within 6 months

Secondary

MeasureTime frame
For carers: 1. Burden is measured using the Burden Assessment Scale (BAS) at baseline, 14 weeks and 40 weeks post randomisation 2. Mental wellbeing is measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline, 14 weeks and 40 weeks post randomisation 3. Family relationships are measured using The Family Questionnaire (TFQ) at baseline, 14 weeks and 40 weeks post randomisation 4. Health-related quality of life is measured using the EQ-5D-5L at baseline, 14 weeks and 40 weeks post randomisation 5. Capability wellbeing is measured using the ICECAP-A at baseline, 14 weeks and 40 weeks post randomisation 6. Carer costs are measured using the Client Services Receipt Inventory at baseline, 14 weeks and 40 weeks post randomisation 7. Experiences of FC; it's impact on their lives; positive and negative aspects of the course; and potential benefits for service users measured by interview during follow-up period For service users: 1. Mental wellbeing is measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline, 14 weeks and 40 weeks post randomisation 2. Social functioning is measured using Work and Social Adjustment Scale (WSAS) at baseline, 14 weeks and 40 weeks post randomisation 3. Health-related quality of life is measured using the EQ-5D-5L at baseline, 14 weeks and 40 weeks post randomisation 4. Capability wellbeing is measured using the ICECAP-A at baseline, 14 weeks and 40 weeks post randomisation 5. Service user costs are measured using the Client Services Receipt Inventory at baseline, 14 weeks and 40 weeks post randomisation Course facilitators will be interviewed about the delivery of FC; the value of the training and supervision; and the acceptability, strengths and weaknesses of the intervention during follow-up period

Countries

England, United Kingdom

Contacts

Public ContactElizabeth Mair
elizabeth.mair@york.ac.uk+44 1904 328810

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026