Condition category
Mental and Behavioural Disorders
Date applied
13/05/2005
Date assigned
30/06/2005
Last edited
03/04/2013
Prospective/Retrospective
Prospectively 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

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

  1. 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.

Additional files

Editorial Notes