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

Primary Purpose

Binge-Eating Disorder, Binge Eating

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy guided self help (CBTgsh)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Binge-Eating Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Medical School Department of PsychiatryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self-help CBT

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility of providing intervention-consent
Percentage of eligible participants who consent to intervention
Feasibility of providing intervention-completion Participants' ratings of satisfaction with the intervention
Percentage of eligible participants who complete intervention
Ratings of Acceptability of intervention to participants
Participants' ratings of suitability of intervention on visual analogue scale with anchors of strongly agree to strongly disagree
Ratings of Acceptability of intervention to participants
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
Ratings of Acceptability of intervention to participants
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
Ratings of Acceptability of intervention to participants
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
Ratings of participants' satisfaction with intervention with anchors strongly agree to strongly disagree
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
Ratings of participants' satisfaction with intervention
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
Ratings of participants' satisfaction with intervention
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree

Secondary Outcome Measures

Likely effectiveness -Eating difficulties
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.
Likely effectiveness -Eating difficulties
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.
Likely effectiveness - impairment due to eating difficulties
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).
Likely effectiveness - impairment due to eating difficulties
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).
Likely effectiveness - depression
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.
Likely effectiveness - depression
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.

Full Information

First Posted
November 16, 2021
Last Updated
March 17, 2023
Sponsor
Yale University
Collaborators
National Eating Disorders Association
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1. Study Identification

Unique Protocol Identification Number
NCT05143866
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Eating Disorders Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder, Binge Eating

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility with pre post assessment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-help CBT
Arm Type
Experimental
Arm Description
Evidence based book detailing self-help program to follow plus Telephone support from a non specialist guide
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy guided self help (CBTgsh)
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of providing intervention-consent
Description
Percentage of eligible participants who consent to intervention
Time Frame
week 0 (baseline)
Title
Feasibility of providing intervention-completion Participants' ratings of satisfaction with the intervention
Description
Percentage of eligible participants who complete intervention
Time Frame
16 weeks
Title
Ratings of Acceptability of intervention to participants
Description
Participants' ratings of suitability of intervention on visual analogue scale with anchors of strongly agree to strongly disagree
Time Frame
At Baseline - before start of intervention
Title
Ratings of Acceptability of intervention to participants
Description
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
Time Frame
16 weeks
Title
Ratings of Acceptability of intervention to participants
Description
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
Time Frame
10 months
Title
Ratings of Acceptability of intervention to participants
Description
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
Time Frame
16 months
Title
Ratings of participants' satisfaction with intervention with anchors strongly agree to strongly disagree
Description
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
Time Frame
16 weeks
Title
Ratings of participants' satisfaction with intervention
Description
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
Time Frame
10 months
Title
Ratings of participants' satisfaction with intervention
Description
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Likely effectiveness -Eating difficulties
Description
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.
Time Frame
week 0 (baseline) and week 16 (end of intervention)
Title
Likely effectiveness -Eating difficulties
Description
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.
Time Frame
week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
Title
Likely effectiveness - impairment due to eating difficulties
Description
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).
Time Frame
Week 0 (baseline) and week 16 (end of intervention)
Title
Likely effectiveness - impairment due to eating difficulties
Description
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).
Time Frame
Week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
Title
Likely effectiveness - depression
Description
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.
Time Frame
Week 0 and week 16 (end of intervention)
Title
Likely effectiveness - depression
Description
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.
Time Frame
Week 0 and week 64 (48 weeks/1 Year after end of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zafra Cooper, DPhil
Phone
1 4752879176
Email
zafra.cooper@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabe Gavito, MS
Organizational Affiliation
National Eating Disorders Association
Official's Role
Study Director
Facility Information:
Facility Name
Yale Medical School Department of Psychiatry
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zafra Cooper
Phone
475-287-9176
Email
zafra.cooper@yale.edu
First Name & Middle Initial & Last Name & Degree
Gabe Gavito
Email
ggavito@nationaleatingdisorders.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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