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 |
| Protocol serial number | 03/0332 |
| Sponsor | King's College London (UK) |
| Funder | Health Services Research Committee South London and Maudsley NHS Trust (UK) |
- 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 |
|---|---|
| U.Schmidt@iop.kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Carer-related measures: Hospital Anxiety and Depression scale (Zigmond & Snaith, 1983) |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Section of Eating Disorders
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
