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

NCT05143866 | Completed

• 2 other identifiers: 2000031521No NIH funding
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge-Eating Disorder; Binge Eating

Outcome Measures

Primary Outcomes (9)

• Feasibility of providing intervention-consent

  Percentage of eligible participants who consent to intervention

  week 0 (baseline)

• Feasibility of providing intervention-completion Participants' ratings of satisfaction with the intervention

  Percentage of eligible participants who complete intervention

  16 weeks

• 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

  At Baseline - before start of intervention

• Ratings of Acceptability of intervention to participants

  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

  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

  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

  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

  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

  Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree

  16 months

Secondary Outcomes (6)

• Likely effectiveness -Eating difficulties

  week 0 (baseline) and week 16 (end of intervention)

• Likely effectiveness -Eating difficulties

  week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)

• Likely effectiveness - impairment due to eating difficulties

  Week 0 (baseline) and week 16 (end of intervention)

• Likely effectiveness - impairment due to eating difficulties

  Week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)

• Likely effectiveness - depression

  Week 0 and week 16 (end of intervention)

Study Arms (1)

Self-help CBT

EXPERIMENTAL

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)

Interventions

Cognitive behavioral therapy guided self help (CBTgsh) 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

Self-help CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Eating Disorders Association: collaborator

Study Sites (1)

Yale Medical School Department of Psychiatry

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder; Bulimia

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabe Gavito, MS

  National Eating Disorders Association

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry (adjunct)

Model Details: Feasibility with pre post assessment

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 3, 2021
• Study Start: February 15, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)