Overview

This trial is active, not recruiting.

Conditions bulimia nervosa, eating disorder not otherwise specified, binge eating disorder
Treatments face-to-face self-help, e-mail self-help, waiting list
Sponsor Oxford Health NHS Foundation Trust
Start date August 2013
End date August 2017
Trial size 102 participants
Trial identifier NCT01832792, OxGSH1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Arm
(Experimental)
In this condition, participants complete a self-help intervention with the support of a therapist. This lasts 12 weeks.
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.
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)
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.
waiting list
Waiting list condition - participants assigned to a waiting list (no intervention) condition

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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
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
HAq-II
time frame: 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

Eligibility Criteria

Male or female participants at least 17 years old.

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)

Additional Information

Official title Guided Self-help for Binge Eating
Principal investigator Paul E Jenkins, DClinPsychol
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Oxford Health NHS Foundation Trust.