Randomised controlled trial of COPe-support online resource for carers

Not Applicable

Completed

• Conditions: Psychosis; Mental and Behavioural Disorders

• Registration Number: ISRCTN89563420
• Lead Sponsor: St George’s, University of London

Brief Summary

2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/31389333 intervention development (added 09/08/2019) 2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32183772 protocol (added 19/03/2020) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35107439/ results of an interview study assessing the acceptability of the intervention and carer experiences (added 03/02/2022) 2022 Results article in https://doi.org/10.1016/S2589-7500(22)00031-0 (added 27/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-02
• Study Completion: 2020-12-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 464

Inclusion Criteria

The online intervention COPe-support is designed for carers supporting a loved one affected by psychosis. Carers include family members with a biological or non-biological relationship (e.g. parents, siblings, spouses, and other relatives) or a close friend supporting a loved one affected by psychosis. Only one carer per psychosis patient will be included in the study. Specific inclusion criteria include carers who are:
1. Adult aged 18 or over
2. Those who have at least weekly contacts with the cared-for person, although these contacts could be in a variety of formats, e.g. face to face, phone calls, emails, or social media such as facebook, twitter, text messages
3. Living in England during the study period
4. Able to communicate in English in usual online communications
5. Have regular access to the internet

Exclusion Criteria

Regrettably, carers with the following characteristics cannot be accepted into the RCT:
1. Those aged below 18
2. Those who cannot communicate in English
3. Those not able to access and use online communications
4. Those who cares for a loved one affected by psychosis but another relative/close friend who also shares a caring role for the same individual has already participated in the study (to avoid a clustering effect)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Carers’ mental wellbeing, assessed using Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), at end of intervention use (i.e. 20 weeks)

Secondary Outcome Measures

Name	Time	Method
<br> Secondary outcomes include the following domains, assessed using the respective tools, at 20 weeks:<br> 1. Carer’s mental health knowledge, assessed using Mental Health Knowledge Schedule (MAKS)<br> 2. Carer’s caregiving experiences, both negative appraisal and positive appraisal, measured by subtotals of Experience of Caregiving Inventory (ECI)<br> 3. Family relationship and communication, assessed by Family Questionnaire (FQ)<br> 4. Carer’s perceived social support, measured with Carer Wellbeing and Support Questionnaire (CWS)<br> 5. Quality of life, assessed using EuroQoL 5-level EQ-5D (EQ-5D-5L).<br>