Binge-Eating DisorderNCT05143866
A Pilot Study of Evidence-based Guided Self-help for the Treatment of Binge Eating
A study testing Cognitive behavioral therapy guided self help (CBTgsh) in people with Binge-Eating Disorder and Binge Eating, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge-Eating Disorder, Binge Eating
- What is being tested?
- Cognitive behavioral therapy guided self help (CBTgsh)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Medical School Department of Psychiatry
New Haven, Connecticut, 06511
About this study
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
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
- Being tested
- Cognitive behavioral therapy guided self help (CBTgsh)
- Medical subject headings
- Binge-Eating Disorder, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy guided self help (CBTgsh)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Self-help CBT | Experimental | Evidence based book detailing self-help program to follow plus Telephone support from a non specialist guide Receives: Behavioral: Cognitive behavioral therapy guided self help (CBTgsh) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of providing intervention-consent
Percentage of eligible participants who consent to intervention
Measured: week 0 (baseline)
Feasibility of providing intervention-completion Participants' ratings of satisfaction with the intervention
Percentage of eligible participants who complete intervention
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 16 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Week 0 and week 64 (48 weeks/1 Year after end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start15 Feb 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility with pre post assessment
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eating Disorders Association
- Responsible party
- Principal investigator, Zafra Cooper, Yale University
- Investigators
- Gabe Gavito, MS, Study director, National Eating Disorders Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143866
- Sponsor's protocol ID
- 2000031521
- Other IDs
- No NIH funding
- Status last verified
- Dec 2024
- First submitted
- 16 Nov 2021
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05143866
- Acronym / sponsor ID
- 2000031521
- Conditions
- Binge-Eating Disorder, Binge Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Eating Disorders Association
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility with pre post assessment
| Arm | Type | Receives |
|---|---|---|
| Self-help CBT | Experimental | Behavioral: Cognitive behavioral therapy guided self help (CBTgsh)Evidence based book detailing self-help program to follow plus Telephone support from a non specialist guide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Self-help CBT |
Primary outcome
Feasibility of providing intervention-consent
Time frame: week 0 (baseline)
Percentage of eligible participants who consent to intervention
Feasibility of providing intervention-completion Participants' ratings of satisfaction with the intervention
Time frame: 16 weeks
Percentage of eligible participants who complete intervention
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
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
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
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
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
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
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
6 secondary outcomes
Likely effectiveness -Eating difficulties
Time frame: week 0 (baseline) and week 16 (end of intervention)
Likely effectiveness -Eating difficulties
Time frame: week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
Likely effectiveness - impairment due to eating difficulties
Time frame: Week 0 (baseline) and week 16 (end of intervention)
Likely effectiveness - impairment due to eating difficulties
Time frame: Week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
Likely effectiveness - depression
Time frame: Week 0 and week 16 (end of intervention)
Likely effectiveness - depression
Time frame: Week 0 and week 64 (48 weeks/1 Year after end of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabe Gavito, MS study director
National Eating Disorders Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy guided self help (CBTgsh) in people with Binge-Eating Disorder and Binge Eating, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of providing intervention-consent (time frame: week 0 (baseline)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.