Guided Self-help for Binge Eating

March 31, 2017 updated by: Oxford Health NHS Foundation Trust

Guided self-help (GSH) is a recommended first-step treatment for bulimia nervosa, binge eating disorder, and atypical variants of these disorders. The current study proposes to investigate the effectiveness of providing GSH either face-to-face or via e-mail, also using a delayed treatment control condition. Symptom outcomes will be assessed, and an estimate of cost-effectiveness made. Results are proposed to be disseminated locally and internationally (through submission to conferences and peer-reviewed journals), and will hopefully inform local service provision.

Please note that we are only able to offer the intervention to individuals who are currently registered with a General Practitioner that is covered by Oxford Health NHS Foundation Trust - this is typically restricted to practices in Oxfordshire, Buckinghamshire, and parts of Wiltshire.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7JX
        • Oxford Health NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Registration with a General Practitioner covered by Oxford Health NHS Foundation Trust (typically: Oxfordshire, Buckinghamshire, parts of Wiltshire)
  • Primary diagnosis of an eating disorder with recurrent binge eating (BN, EDNOS [BN-type] or BED)
  • Age above 17.5 years (box below requires whole numbers)

Exclusion Criteria:

  • A severe eating disorder (e.g., one complicated by medical issues that would not be best managed by a self-help intervention)
  • BMI <18.5
  • Rapid weight loss (regardless of BMI)
  • current excessive drug use
  • active and untreated psychosis (the latter two are usually exclusion criteria to the EDS)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-help
In this condition, participants complete a self-help intervention with the support of a therapist. This lasts 12 weeks.
Other: Face-to-face self-help
Participants in this arm will receive face-to-face self-help; that is, self-help with the support of a therapist, attending the clinic in person.
Other: E-mail self-help
Participants in this arm will receive e-mail self-help; that is, self-help with the support of a therapist, provided via e-mail.
Other: Waiting List
One third of participants will be allocated to a treatment waiting list, after which they will be randomised to one of the other two arms.
Other: Waiting List
Waiting list condition - participants assigned to a waiting list (no intervention) condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EDE-Q
Time Frame: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
The EDE-Q is given as a measure of eating disorder symptoms in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient's first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up. Binge eating is the primary outcome measure, with other eating disorder symptoms as secondary measures. Change in these symptoms will be assessed over the course of treatment.
Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CORE-OM
Time Frame: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
The CORE-OM is given as a measure of psychological distress in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient's first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up.
Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
RSES
Time Frame: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
The RSES is given as a measure of self-esteem in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient's first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up.
Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
CIA
Time Frame: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
The CIA is given as a measure of psychological functioning (quality of life) in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient's first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up.
Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
HAq-II
Time Frame: End of Session 3 of treatment (3 weeks into treatment)
The Helping Alliance Questionnaire is given as a measure of therapeutic alliance after Session 3 of treatment (after 3 weeks from start of treatment) and again at end-of-treatment.
End of Session 3 of treatment (3 weeks into treatment)
Healthcare Use
Time Frame: Change in healthcare use between Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
A measure of healthcare use was developed for the study and is given at Start-of-treatment, End-of-treatment, and 6-month follow-up. Start-of-treatment will proceed as soon as possible after assessment; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up.
Change in healthcare use between Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapist Time
Time Frame: After every contact with the patient (approx. weekly), including weekly sessions during treatment (12 weeks)
Therapists are asked to indicate (to the nearest 5 minutes) how much time they spend doing clinical / administrative tasks for each patient (patient name not included). Although there are no formal guidelines for how therapists report their time, it should accurately record all contact with patients, and thus is suggested to be completed approximately weekly.
After every contact with the patient (approx. weekly), including weekly sessions during treatment (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford Health NHS Foundation Trust

Investigators

  • Principal Investigator: Paul E Jenkins, DClinPsychol, Oxford Health NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (Estimate)

April 16, 2013

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 31, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OxGSH1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bulimia Nervosa

Clinical Trials on Face-to-face self-help

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe