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Completed

NCT Number: NCT05143866

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

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Key information

Conditions

Binge-Eating Disorder Binge Eating Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Medical School Department of Psychiatry

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Feasibility of providing intervention-consent

    Time frame: week 0 (baseline)

    Percentage of eligible participants who consent to intervention

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

    Time frame: 16 weeks

    Percentage of eligible participants who complete intervention

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Eating Disorders Association

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2021
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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