Guided self-help for eating disorders: A randomised controlled trial

ISRCTN	ISRCTN07665287
DOI	https://doi.org/10.1186/ISRCTN07665287
Secondary identifying numbers	N0626191789

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 27/09/2012

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

Ms Gemma Traviss
Scientific

University of Leeds
Leeds Institute of Health Sciences
Charles Thackrah Building
101 Clarendon Road
Leeds
LS2 9LJ
United Kingdom

Phone	+44
Email	umgt@leeds.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	This study aims to evaluate the effectiveness of this GSH (Guided Self Help) pack in both primary and secondary care as delivered by trained, supervised mental health professionals. Until 15/05/08: - the title was: Guided self-help for eating disorders in primary care - the end date was 31/12/07
Ethics approval(s)	Added 15/05/08: Leeds (East) Research Ethics Committee 06/Q1206/51
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders: Eating disorder
Intervention	A mail shot of GPs able to refer the trained guides will inform GPs of the research project and help them to identify appropriate patients/participants. Once referred to the guide the participant will undergo that guide's service routine screening or assessment process. If the participant meets the inclusion criteria, the project is explained to them verbally and in writing. The participant is also asked to make an appointment with their GP to obtain any relevant blood tests and get their BMI. If a participant is not suitable to participate or does not wish to, they receive the treatment as usual from the service. After consent is given the guide contacts the researcher sending her the consent form. Participants details are anonymised and a code is used. The research randomises the participant to GSH or waiting list control. People randomised to the waiting list control group will remain on the service's waiting list for the amount of time they would usually have done if they were not taking part in the research. The researcher will also contact the participants GP to inform them of the participants involvement in the project.
Intervention type	Other
Primary outcome measure	It would evaluate the outcome of using the pack as compared to a group of people on the waiting list (in terms of mental health, and eating disordered behaviour and psychopathology), the effect of the therapeutic alliance on the GSH and the adherence to and usefulness of the pack as rated by users.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/2006
Completion date	31/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Added 15/05/08: 70
Key inclusion criteria	Participants for the research will be recruited from people accessing primary or secondary mental health care.
Key exclusion criteria	Added 15/05/08: 1. BMI<16 or rapid weight loss 2. <16 years of age 3. If primary difficulty is not an eating disorder 4. High risk of self-harm or suicide 5. Abusing drugs or alcohol 6. Severe depression 7. Major co-morbid physical disorder
Date of first enrolment	01/07/2006
Date of final enrolment	31/08/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Leeds

Leeds
LS2 9LJ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Leeds Partnership Foundation NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
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?
Results article	results	01/01/2011		Yes	No