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

Binge-Eating Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05143866
• Other study ID #: 2000031521
• Secondary ID: No NIH funding
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: Zafra Cooper, DPhil
• Phone: 1 4752879176
• Email: zafra.cooper[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Yale Medical School Department of Psychiatry	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Eating Disorders Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of providing intervention-consent	Percentage of eligible participants who consent to intervention	week 0 (baseline)
Primary	Feasibility of providing intervention-completion Participants' ratings of satisfaction with the intervention	Percentage of eligible participants who complete intervention	16 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	week 0 (baseline) and week 16 (end of intervention)
Secondary	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.	week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
Secondary	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).	Week 0 (baseline) and week 16 (end of intervention)
Secondary	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).	Week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
Secondary	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.	Week 0 and week 16 (end of intervention)
Secondary	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.	Week 0 and week 64 (48 weeks/1 Year after end of intervention)