A pilot randomised controlled trial of the CD-ROM based intervention for carers of people with anorexia nervosa (AN)

ISRCTN ISRCTN33652725
DOI https://doi.org/10.1186/ISRCTN33652725
Secondary identifying numbers 03/0332
Submission date
13/05/2005
Registration date
30/06/2005
Last edited
03/04/2013
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

Dr Ulrike Schmidt
Scientific

Section of Eating Disorders
Box 059
Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Phone +44 (0)20 7848 0160
Email U.Schmidt@iop.kcl.ac.uk

Study information

Study designPilot randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesCarers randomised to receive the computerised intervention will show greater improvements on primary and secondary outcomes compared to the group receiving EDA support.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAnorexia nervosa (AN)
InterventionCD ROM group: The computerised intervention for carers of people with anorexia nervosa has been developed in the SLaM Eating Disorders Unit. This CD-ROM contains 9 interactive modules, which teach carers disease- and self-management skills. It includes information on how to communicate with the young person about their AN, how to support them at meal times to facilitate weight gain and re-establish healthy eating, how to manage crises and conflict, how to assess and manage risk, information on the use of the mental health act, how to address the carers' own needs, how to work with NHS and voluntary services and the role of different practitioners in the Eating Disorders team.

EDA support group: Informal support will be accessed from the EDA (EDA-support) via their helplines and carer support groups where available.
Intervention typeOther
Primary outcome measureCarer-related measures: Hospital Anxiety and Depression scale (Zigmond & Snaith, 1983)
Secondary outcome measuresStandard Family Interview for Expressed Emotion (Hodes et al., 1991); Carer Coping (Pearlin et al., 1991), Experience of Care Giving (Szmukler et al., 1996); MEPS-ED (Platt et al., 1975), uptake of CD-ROM; attitudes to self-help (Williams et al., unpublished). These measures will be given prior to the carer intervention and 3 months later.
Overall study start date30/06/2005
Completion date30/06/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants56
Key inclusion criteriaCarers of patients with AN and eating disorder not otherwise specified (EDNOS) AN recruited via the Eating Disorders Association (EDA)
Key exclusion criteriaCarers of people with other eating disorders
Date of first enrolment30/06/2005
Date of final enrolment30/06/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Section of Eating Disorders
London
SE5 8AF
United Kingdom

Sponsor information

King's College London (UK)
Research organisation

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

Email g.dale@iop.kcl.ac.uk
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Government

Health Services Research Committee South London and Maudsley NHS Trust (UK)

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 01/12/2011 Yes No