Contact information
Type
Scientific
Primary contact
Prof Janet Treasure
ORCID ID
Contact details
Department Academic Psychiatry
5th Floor Thomas Guy House
Guys Hospital
London
SE1 9RT
United Kingdom
+44 (0)207 188 0186
j.treasure@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
238/04
Study information
Scientific title
Collaborative Caring Project: Working with Parents at treatment and secondary prevention of Eating Disorders
Acronym
CCP: WP_ED
Study hypothesis
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
Approved by Multicentre Ethics Research Committee, reference number: 238/04 / MREC N.:04/Q0706/132
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
22/10/2004
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
The participant must currently be caring for a relative with an eating disorder
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
A total of 120 carers divided into 8 groups of 15 carers
Participant exclusion criteria
1. People who are not caring for a relative with an eating disorder
2. Non-English speakers
Recruitment start date
22/10/2004
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department Academic Psychiatry
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)207 848 0675
G.Dale@iop.kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Institute of Psychiatry
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25555418