Condition category
Mental and Behavioural Disorders
Date applied
04/10/2005
Date assigned
22/06/2006
Last edited
28/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.iop.kcl.ac.uk/

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

Publication citations

Additional files

Editorial Notes

28/10/2016: Publication reference added