Guided Self-help for Binge Eating

NCT01832792 | Completed DMC

• 1 other identifier: OxGSH1
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bulimia Nervosa; Eating Disorder Not Otherwise Specified; Binge Eating Disorder

Outcome Measures

Primary Outcomes (1)

• EDE-Q

  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 Outcomes (5)

• CORE-OM

  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

  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

  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

  End of Session 3 of treatment (3 weeks into treatment)

• Healthcare Use

  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 Outcomes (1)

• Therapist Time

  After every contact with the patient (approx. weekly), including weekly sessions during treatment (12 weeks)

Study Arms (2)

Self-help

EXPERIMENTAL

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; Other: E-mail self-help

Waiting List

OTHER

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

Interventions

Face-to-face self-help OTHER

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.

Self-help

E-mail self-help OTHER

Participants in this arm will receive e-mail self-help; that is, self-help with the support of a therapist, provided via e-mail.

Self-help

Waiting List OTHER

Waiting list condition - participants assigned to a waiting list (no intervention) condition

Waiting List

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford Health NHS Foundation Trust: lead

Study Sites (1)

Oxford Health NHS Foundation Trust

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

Related Publications (1)

• Jenkins PE, Luck A, Burrows A, Boughton N. Comparison of face-to-face versus email guided self-help for binge eating: study protocol for a randomised controlled trial. Trials. 2014 May 22;15:181. doi: 10.1186/1745-6215-15-181.

  PMID: 24886555 DERIVED

MeSH Terms

Conditions

Bulimia Nervosa; Binge-Eating Disorder

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Paul E Jenkins, DClinPsychol

  Oxford Health NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 16, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

GB (1)