A pilot randomised controlled trial of the CD-ROM based intervention for carers of people with anorexia nervosa (AN)
ISRCTN | ISRCTN33652725 |
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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
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 |
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U.Schmidt@iop.kcl.ac.uk |
Study information
Study design | Pilot randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 30/06/2005 |
Completion date | 30/06/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 56 |
Key inclusion criteria | Carers of patients with AN and eating disorder not otherwise specified (EDNOS) AN recruited via the Eating Disorders Association (EDA) |
Key exclusion criteria | Carers of people with other eating disorders |
Date of first enrolment | 30/06/2005 |
Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Section of Eating Disorders
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
King's College London (UK)
Research organisation
Research organisation
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
g.dale@iop.kcl.ac.uk | |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/12/2011 | Yes | No |