Clinical trial NCT05143866: A Pilot Study of Evidence-based Guided Self-help for the Treatment of Binge Eating
Official title: Closing the Treatment Gap: A Pilot Study of Evidence-based Guided Self-Help for the Treatment of Binge Eating and Related Disordered Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge-Eating Disorder
Binge Eating
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Eating Disorders Association
First posted: 2021-12-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility with pre post assessment
Primary purpose: OTHER

Brief summary: The purpose of the present pilot study is to evaluate the feasibility, acceptability and likely effectiveness of an evidence-based guided self-help intervention for binge eating and related disordered over-eating in those unable to access clinician provided treatments. If feasible, acceptable and likely to be effective, such interventions could be made available more widely as an early intervention to those in need. Such interventions have the potential to improve quality of life by removing or ameliorating symptoms that impair psychological and social functioning. Eligible participants will receive the guided self-help intervention - an evidence-based self help program in the form of a self-help book plus telephone support and encouragement to follow the program provided by specially trained help-line volunteers. Support completing the self-help program will be provided over a period of 4 months and participants will be followed up for a year after completion of the intervention. Participants will be asked to complete brief online assessments before starting the program, at the end of 4 months when they complete the program and at 6 month and 12 month follow up.


Eligibility criteria: Inclusion Criteria:

* Participant contacted National Eating Disorder Association (NEDA) with binge eating problems or disordered overeating
* Completed NEDA screen and study screen
* Age 18 and over
* Able to speak, understand and read English
* Consenting to guided self-help and completing study assessments

Exclusion Criteria:

* Currently receiving treatment for an eating disorder
* Self-reported weight body mass index (BMI) \<20
* Reported self-induced vomiting, laxative or diuretic use (purging)
* Reports suicidal ideation
* Breast feeding or pregnant
* Receiving treatment for co-existing psychiatric condition (e.g., bipolar disorder, psychotic illness, drug or alcohol dependence

Primary outcomes:
measure: Feasibility of providing intervention-consent
timeFrame: week 0 (baseline)
measure: Feasibility of providing intervention-completion Participants' ratings of satisfaction with the intervention
timeFrame: 16 weeks
measure: Ratings of Acceptability of intervention to participants
timeFrame: At Baseline - before start of intervention
measure: Ratings of Acceptability of intervention to participants
timeFrame: 16 weeks
measure: Ratings of Acceptability of intervention to participants
timeFrame: 10 months
measure: Ratings of Acceptability of intervention to participants
timeFrame: 16 months
measure: Ratings of participants' satisfaction with intervention with anchors strongly agree to strongly disagree
timeFrame: 16 weeks
measure: Ratings of participants' satisfaction with intervention
timeFrame: 10 months
measure: Ratings of participants' satisfaction with intervention
timeFrame: 16 months
Secondary outcomes:
measure: Likely effectiveness -Eating difficulties
timeFrame: week 0 (baseline) and week 16 (end of intervention)
measure: Likely effectiveness -Eating difficulties
timeFrame: week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
measure: Likely effectiveness - impairment due to eating difficulties
timeFrame: Week 0 (baseline) and week 16 (end of intervention)
measure: Likely effectiveness - impairment due to eating difficulties
timeFrame: Week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
measure: Likely effectiveness - depression
timeFrame: Week 0 and week 16 (end of intervention)
measure: Likely effectiveness - depression
timeFrame: Week 0 and week 64 (48 weeks/1 Year after end of intervention)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Medical School Department of Psychiatry
state: Connecticut
Study officials:
affiliation: National Eating Disorders Association
name: Gabe Gavito, MS
role: STUDY_DIRECTOR
References: