Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
27/09/2012
Prospective/Retrospective
Retrospectively 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

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes