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

Study Overview
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Brief Summary
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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.

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

Conditions
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Binge-Eating Disorder, Binge Eating

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy guided self help (CBTgsh)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility with pre post assessment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-help CBT<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) |