Collaborative Caring Project: Working with Parents at treatment and secondary prevention of Eating Disorders

ISRCTN	ISRCTN56376745
DOI	https://doi.org/10.1186/ISRCTN56376745
Protocol serial number	238/04
Sponsor	King's College London (UK)
Funder	Institute of Psychiatry

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

Department Academic Psychiatry
5th Floor Thomas Guy House
Guys Hospital
London
SE1 9RT
United Kingdom

Phone	+44 (0)207 188 0186
Email	j.treasure@iop.kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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)
Key secondary outcome measure(s)	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.
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
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

United Kingdom
England

Study participating centre

Department Academic Psychiatry

London
SE1 9RT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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