Clinical trial NCT01832792: Guided Self-help for Binge Eating
Official title: Guided Self-help for Binge Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Eating Disorder Not Otherwise Specified
Binge Eating Disorder
Lead sponsor: Oxford Health NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2013-04-16
Enrollment: 122
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: EDE-Q
timeFrame: 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
timeFrame: 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
measure: RSES
timeFrame: 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
measure: CIA
timeFrame: 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
measure: HAq-II
timeFrame: End of Session 3 of treatment (3 weeks into treatment)
measure: Healthcare Use
timeFrame: 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:
measure: Therapist Time
timeFrame: After every contact with the patient (approx. weekly), including weekly sessions during treatment (12 weeks)
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Health NHS Foundation Trust
state: Oxfordshire
Study officials:
affiliation: Oxford Health NHS Foundation Trust
name: Paul E Jenkins, DClinPsychol
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.