Collaborative Caring Project: Working with Parents at treatment and secondary prevention of Eating Disorders
ISRCTN | ISRCTN56376745 |
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DOI | https://doi.org/10.1186/ISRCTN56376745 |
Secondary identifying numbers | 238/04 |
- Submission date
- 04/10/2005
- Registration date
- 22/06/2006
- Last edited
- 28/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Janet Treasure
Scientific
Scientific
Department Academic Psychiatry
5th Floor Thomas Guy House
Guys Hospital
London
SE1 9RT
United Kingdom
Phone | +44 (0)207 188 0186 |
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j.treasure@iop.kcl.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | Collaborative Caring Project: Working with Parents at treatment and secondary prevention of Eating Disorders |
Study acronym | CCP: WP_ED |
Study objectives | Aim: to test the efficacy and acceptability in a preliminary randomised controlled trial (RCT) of skills training workshops for carers Hypothesis 1: the carers workshops reduce the level of difficulties and distress involved in caring for someone with an eating disorder Hypothesis 2: if the carers reduce their distress, this improves the outcome in people with eating disorders (ED) |
Ethics approval(s) | Approved by Multicentre Ethics Research Committee, reference number: 238/04 / MREC N.:04/Q0706/132 |
Health condition(s) or problem(s) studied | Having a relative with an eating disorder |
Intervention | Design: the primary caregiver will be randomised to either: 1. Immediate workshop 2. Waiting list Randomisation schedules will be generated independently by the Institute of Psychiatry (IoP) clinical trials unit. Blind assessments of outcome will be conducted at: 1. At the time of randomisation 2. At the end of treatment 3. After three months Structure and contents of the workshops have been developed as a collaborative care intervention. This includes a carer manual with modules on: coping, medical risk, understanding change, communication, emotion processing, problem solving, interpersonal relationships, managing eating and other difficult behaviours, supplemented with skills-based workshops. The workshops teach practical skills such as key elements of motivational interviewing (MI) and cognitive behaviour therapy (CBT). Procedure: potential participants from Eating Disorder Association (EDA) and South London and Maudsley NHS Trust (SLAM). Carers will be divided into 8 groups of 15 carers. There will be six fortnightly sessions spread over a period of three months. Each session will last for two hours. |
Intervention type | Other |
Primary outcome measure | Carers: 1. General Health Questionnaire (GHQ-12; Goldberg et al, 1988) 2. Experience of Caregiving Inventory - Eating Disorder Version (ECI-EDV) Patients: 1. Short Evaluation of Eating Disorder (SEED; Bauer et al., 2005) 2. Global Assessment Scale (adapted from Spitzer et al. 1986) |
Secondary outcome measures | Process measures: Carers: expressed emotion, 5-minute speech sample (Mangana et al, 1986) Acceptability measures: the attendance at workshops will be monitored. Family satisfaction questionnaire will be used. |
Overall study start date | 22/10/2004 |
Completion date | 31/12/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | A total of 120 carers divided into 8 groups of 15 carers |
Key inclusion criteria | The participant must currently be caring for a relative with an eating disorder |
Key exclusion criteria | 1. People who are not caring for a relative with an eating disorder 2. Non-English speakers |
Date of first enrolment | 22/10/2004 |
Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department Academic Psychiatry
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom
Phone | +44 (0)207 848 0675 |
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G.Dale@iop.kcl.ac.uk | |
Website | http://www.iop.kcl.ac.uk/ |
https://ror.org/0220mzb33 |
Funders
Funder type
University/education
Institute of Psychiatry
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 28/02/2015 | Yes | No |
Editorial Notes
28/10/2016: Publication reference added