Contact information
Type
Scientific
Primary contact
Ms Gemma Traviss
ORCID ID
Contact details
University of Leeds
Leeds Institute of Health Sciences
Charles Thackrah Building
101 Clarendon Road
Leeds
LS2 9LJ
United Kingdom
+44
umgt@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0626191789
Study information
Scientific title
Acronym
Study hypothesis
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
Added 15/05/08:
Leeds (East) Research Ethics Committee 06/Q1206/51
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/07/2006
Overall trial end date
31/08/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Participants for the research will be recruited from people accessing primary or secondary mental health care.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Added 15/05/08: 70
Participant 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
Recruitment start date
01/07/2006
Recruitment end date
31/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
Leeds
LS2 9LJ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Partnership Foundation 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/21092933
Publication citations
-
Results
Traviss GD, Heywood-Everett S, Hill AJ, Guided self-help for disordered eating: A randomised control trial., Behav Res Ther, 2011, 49, 1, 25-31, doi: 10.1016/j.brat.2010.10.007.