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Clinical Trials/NCT01832792
NCT01832792CompletedNot Applicable

Guided Self-help for Binge Eating

Oxford Health NHS Foundation Trust2 sites in 1 country122 target enrollmentStarted: August 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
122
Locations
2
Primary Endpoint
EDE-Q

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment

Eligibility Criteria

Ages
17 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

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 Outcomes

  • 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)
  • 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)
  • 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)
  • HAq-II(End of Session 3 of treatment (3 weeks into treatment))

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (2)

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