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A Pilot Study of Evidence-based Guided Self-help for the Treatment of Binge Eating

NCT ID: NCT05143866

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Binge-Eating Disorder Binge Eating

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility with pre post assessment
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Self-help CBT

Evidence based book detailing self-help program to follow plus Telephone support from a non specialist guide

Group Type EXPERIMENTAL

Cognitive behavioral therapy guided self help (CBTgsh)

Intervention Type BEHAVIORAL

Based on evidence based cognitive behavioral treatment for eating disorders. Self-help version described in self-help book. Participant follows self-help program with encouragement and support of a non specialist guide

Interventions

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Cognitive behavioral therapy guided self help (CBTgsh)

Based on evidence based cognitive behavioral treatment for eating disorders. Self-help version described in self-help book. Participant follows self-help program with encouragement and support of a non specialist guide

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eating Disorders Association

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Zafra Cooper

Professor of Psychiatry (adjunct)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabe Gavito, MS

Role: STUDY_DIRECTOR

National Eating Disorders Association

Locations

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Yale Medical School Department of Psychiatry

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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No NIH funding

Identifier Type: OTHER

Identifier Source: secondary_id

2000031521

Identifier Type: -

Identifier Source: org_study_id