Guided Self-help for Binge Eating

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Oxford Health NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Oxford Health NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01832792
First received: April 9, 2013
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Bulimia Nervosa
Eating Disorder Not Otherwise Specified
Binge Eating Disorder
Other: Face-to-face self-help
Other: E-mail self-help
Other: Waiting List

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Guided Self-help for Binge Eating

Resource links provided by NLM:


Further study details as provided by Oxford Health NHS Foundation Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 102
Study Start Date: August 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832792

Contacts
Contact: Paul E Jenkins, DClinPsychol +441865738847 paul.jenkins@oxfordhealth.nhs.uk

Locations
United Kingdom
Oxford Health NHS Foundation Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Contact: Paul E Jenkins    +441865738847    paul.jenkins@oxfordhealth.nhs.uk   
Sponsors and Collaborators
Oxford Health NHS Foundation Trust
Investigators
Principal Investigator: Paul E Jenkins, DClinPsychol Oxford Health NHS Foundation Trust
  More Information

No publications provided by Oxford Health NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oxford Health NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01832792     History of Changes
Other Study ID Numbers: OxGSH1
Study First Received: April 9, 2013
Last Updated: November 18, 2013
Health Authority: United Kingdom: National Health Service
United States: Federal Government

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Bulimia Nervosa
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014