Contact information
Type
Scientific
Primary contact
Dr Ulrike Schmidt
ORCID ID
Contact details
Section of Eating Disorders
Box 059
Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0160
U.Schmidt@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
03/0332
Study information
Scientific title
Acronym
Study hypothesis
Carers randomised to receive the computerised intervention will show greater improvements on primary and secondary outcomes compared to the group receiving EDA support.
Ethics approval
Not provided at time of registration
Study design
Pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anorexia nervosa (AN)
Intervention
CD 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Carer-related measures: Hospital Anxiety and Depression scale (Zigmond & Snaith, 1983)
Secondary outcome measures
Standard 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(Szmukler et al., 1996); MEPS-ED (Platt et al., 1975), uptake of CD-ROM; attitudes to self-help (Williams et al., unpublished).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 trial start date
30/06/2005
Overall trial end date
30/06/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Carers of patients with AN and eating disorder not otherwise specified (EDNOS) AN recruited via the Eating Disorders Association (EDA)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
56
Participant exclusion criteria
Carers of people with other eating disorders
Recruitment start date
30/06/2005
Recruitment end date
30/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Section of Eating Disorders
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
g.dale@iop.kcl.ac.uk
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Health Services Research Committee South London and Maudsley NHS Trust (UK)
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
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21733215
Publication citations
-
Results
Grover M, Naumann U, Mohammad-Dar L, Glennon D, Ringwood S, Eisler I, Williams C, Treasure J, Schmidt U, A randomized controlled trial of an Internet-based cognitive-behavioural skills package for carers of people with anorexia nervosa., Psychol Med, 2011, 41, 12, 2581-2591, doi: 10.1017/S0033291711000766.