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

ISRCTN ISRCTN56376745
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

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleCollaborative Caring Project: Working with Parents at treatment and secondary prevention of Eating Disorders
Study acronymCCP: WP_ED
Study objectivesAim: 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) studiedHaving a relative with an eating disorder
InterventionDesign: 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 typeOther
Primary outcome measureCarers:
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 measuresProcess 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 date22/10/2004
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsA total of 120 carers divided into 8 groups of 15 carers
Key inclusion criteriaThe participant must currently be caring for a relative with an eating disorder
Key exclusion criteria1. People who are not caring for a relative with an eating disorder
2. Non-English speakers
Date of first enrolment22/10/2004
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department Academic Psychiatry
London
SE1 9RT
United Kingdom

Sponsor information

King's College London (UK)
University/education

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom

Phone +44 (0)207 848 0675
Email G.Dale@iop.kcl.ac.uk
Website http://www.iop.kcl.ac.uk/
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

University/education

Institute of Psychiatry

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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