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

December 17, 2024 updated by: Zafra Cooper, Yale University

Closing the Treatment Gap: A Pilot Study of Evidence-based Guided Self-Help for the Treatment of Binge Eating and Related Disordered Eating

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale Medical School Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-help CBT
Evidence based book detailing self-help program to follow plus Telephone support from a non specialist guide
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of providing intervention-consent
Time Frame: week 0 (baseline)
Percentage of eligible participants who consent to intervention
week 0 (baseline)
Feasibility of providing intervention-completion Participants' ratings of satisfaction with the intervention
Time Frame: 16 weeks
Percentage of eligible participants who complete intervention
16 weeks
Ratings of Acceptability of intervention to participants
Time Frame: At Baseline - before start of intervention
Participants' ratings of suitability of intervention on visual analogue scale with anchors of strongly agree to strongly disagree
At Baseline - before start of intervention
Ratings of Acceptability of intervention to participants
Time Frame: 16 weeks
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
16 weeks
Ratings of Acceptability of intervention to participants
Time Frame: 10 months
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
10 months
Ratings of Acceptability of intervention to participants
Time Frame: 16 months
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
16 months
Ratings of participants' satisfaction with intervention with anchors strongly agree to strongly disagree
Time Frame: 16 weeks
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
16 weeks
Ratings of participants' satisfaction with intervention
Time Frame: 10 months
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
10 months
Ratings of participants' satisfaction with intervention
Time Frame: 16 months
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likely effectiveness -Eating difficulties
Time Frame: week 0 (baseline) and week 16 (end of intervention)
Change in global score on a well validated self-report measure of eating disorder attitudes and behavior-Eating Disorder Questionnaire. Possible range from 0 - 6 where higher score indicates worse symptoms.
week 0 (baseline) and week 16 (end of intervention)
Likely effectiveness -Eating difficulties
Time Frame: week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
Change in global score on a well validated self-report measure of eating disorder attitudes and behavior-Eating Disorder Questionnaire. Possible range from 0 - 6 where higher score indicates worse symptoms.
week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
Likely effectiveness - impairment due to eating difficulties
Time Frame: Week 0 (baseline) and week 16 (end of intervention)
Change in impairment due to eating difficulties score on well validated self report measure the Clinical Impairment assessment (CIA). Possible scores range from 0 (no impairment ) to 48 (highest level of impairment).
Week 0 (baseline) and week 16 (end of intervention)
Likely effectiveness - impairment due to eating difficulties
Time Frame: Week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
Change in impairment due to eating difficulties score on well validated self report measure the Clinical Impairment assessment (CIA). Possible scores range from 0 (no impairment ) to 48 (highest level of impairment).
Week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
Likely effectiveness - depression
Time Frame: Week 0 and week 16 (end of intervention)
Change in depression scores on well validated self report measure, Patient Health Questionnaire (PHQ 9). Possible scores 0 (no depressed mood) to 27 (highest levels of depressive symptoms.
Week 0 and week 16 (end of intervention)
Likely effectiveness - depression
Time Frame: Week 0 and week 64 (48 weeks/1 Year after end of intervention)
Change in depression scores on well validated self report measure, Patient Health Questionnaire (PHQ 9). Possible scores 0 (no depressed mood) to 27 (highest levels of depressive symptoms.
Week 0 and week 64 (48 weeks/1 Year after end of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Eating Disorders Association

Investigators

  • Study Director: Gabe Gavito, MS, National Eating Disorders Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

November 20, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000031521
  • No NIH funding (Other Identifier: 11.09.23)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe