A Single-session Intervention Adaptation of the Habit Framework for the Prevention of Eating Disorders

NCT ID: NCT06861608

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2026-07-15

Brief Summary

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The purpose of this proposal is to launch the first trial of a single-session intervention (SSI) specifically for the prevention of eating disorders (EDs).

Detailed Description

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The emergence of EDs is bimodal such that there is a period of risk in early adolescence and a period of risk in late adolescence/early adulthood. EDs can lead to significant mental and physical health consequences and have one of the highest mortality rates of any mental illness. Prevention and treatment programs for EDs are fraught with barriers to access, particularly related to seeking care in-person. SSIs have been identified as a pathway to address the gap in care for EDs after showing promise for other psychiatric problems, including depression, anxiety, and suicidality .

Conditions

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Eating Disorder Not Otherwise Specified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial to test the acceptability and feasibility of a single-session intervention utilizing the habit framework for adolescents and young adults who are at-risk of developing a restrictive eating disorder
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental: psychoeducation experience single-session intervention (SSI)

This online randomized controlled trial of a habit training intervention includes one 30-minute session for young adults endorsing high levels of eating pathology. The intervention will occur at one timepoint.

Group Type EXPERIMENTAL

Screening Questionnaire

Intervention Type BEHAVIORAL

Individuals will complete an online screening survey through an online study advertisement to determine initial eligibility. The screening survey will ask participants to report their gender and age and complete the Eating Attitudes Test - 26-item (EAT-26). EAT-26 scores equal to or greater than 20 indicate risk for an eating disorder. EAT-26, participants will meet the "referral criteria" which includes a score of 20 or more or meeting frequency criteria on bingeing, purging, laxative/diuretic use, and/or exercise. If an interested individual is not eligible, they will be notified that they are not currently eligible for the study and provided with resources.

Pre-Intervention Questionnaires (~10 minutes)

Intervention Type BEHAVIORAL

Eligible participants will complete pre-intervention questionnaires including demographics and symptom measures.

SSI (Single-session intervention (~30 minutes) Active arm

Intervention Type BEHAVIORAL

The SSI will consist of four components: 1)psychoeducation, 2) real-life examples, 3) common questions and misconceptions, and 4) providing advice to other young adults. Psychoeducation will focus on the brain bases of habit formation and EDs, as per REACH+ treatment manual. Participants will then be asked to think of a real-life example of an eating habit in which they have been engaged, such as limiting their intake of dessert foods. Participants will then be provided with REACH+ developed psychoeducation regarding changing habits, including information on competing responses, stimulus control, and exposure. Participants will have the opportunity to write out how they could use one of these strategies to tackle the habit that they previously wrote about. They will be provided with a worksheet to help them move through each aspect of changing their habit based on what they learned.

End-of-Intervention Questionnaires (~5 minutes)

Intervention Type BEHAVIORAL

Participants will complete additional questionnaires at the end of the intervention, including acceptability ratings and program feedback. Participants will provide an email address at the end of the questionnaires for receipt of four-week follow-up questionnaires.

Control: will be matched to the SSI by including both reading and writing exercises.

The control intervention will consist of supportive therapy focusing on sharing emotions and include an introduction to emotions, writing about emotions, testimonials from other adolescents about the power of sharing emotions, and an exercise asking adolescents how different situations might make them feel.

Group Type PLACEBO_COMPARATOR

Screening Questionnaire

Intervention Type BEHAVIORAL

Individuals will complete an online screening survey through an online study advertisement to determine initial eligibility. The screening survey will ask participants to report their gender and age and complete the Eating Attitudes Test - 26-item (EAT-26). EAT-26 scores equal to or greater than 20 indicate risk for an eating disorder. EAT-26, participants will meet the "referral criteria" which includes a score of 20 or more or meeting frequency criteria on bingeing, purging, laxative/diuretic use, and/or exercise. If an interested individual is not eligible, they will be notified that they are not currently eligible for the study and provided with resources.

Pre-Intervention Questionnaires (~10 minutes)

Intervention Type BEHAVIORAL

Eligible participants will complete pre-intervention questionnaires including demographics and symptom measures.

SSI (Single-session intervention (~30 minutes) control arm

Intervention Type BEHAVIORAL

The control condition will be matched to the SSI by including both reading and writing exercises. The control intervention will consist of supportive therapy focusing on sharing emotions and include an introduction to emotions, writing about emotions, testimonials from other adolescents about the power of sharing emotions, and an exercise asking adolescents how different situations might make them feel.

End-of-Intervention Questionnaires (~5 minutes)

Intervention Type BEHAVIORAL

Participants will complete additional questionnaires at the end of the intervention, including acceptability ratings and program feedback. Participants will provide an email address at the end of the questionnaires for receipt of four-week follow-up questionnaires.

Interventions

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Screening Questionnaire

Individuals will complete an online screening survey through an online study advertisement to determine initial eligibility. The screening survey will ask participants to report their gender and age and complete the Eating Attitudes Test - 26-item (EAT-26). EAT-26 scores equal to or greater than 20 indicate risk for an eating disorder. EAT-26, participants will meet the "referral criteria" which includes a score of 20 or more or meeting frequency criteria on bingeing, purging, laxative/diuretic use, and/or exercise. If an interested individual is not eligible, they will be notified that they are not currently eligible for the study and provided with resources.

Intervention Type BEHAVIORAL

Pre-Intervention Questionnaires (~10 minutes)

Eligible participants will complete pre-intervention questionnaires including demographics and symptom measures.

Intervention Type BEHAVIORAL

SSI (Single-session intervention (~30 minutes) Active arm

The SSI will consist of four components: 1)psychoeducation, 2) real-life examples, 3) common questions and misconceptions, and 4) providing advice to other young adults. Psychoeducation will focus on the brain bases of habit formation and EDs, as per REACH+ treatment manual. Participants will then be asked to think of a real-life example of an eating habit in which they have been engaged, such as limiting their intake of dessert foods. Participants will then be provided with REACH+ developed psychoeducation regarding changing habits, including information on competing responses, stimulus control, and exposure. Participants will have the opportunity to write out how they could use one of these strategies to tackle the habit that they previously wrote about. They will be provided with a worksheet to help them move through each aspect of changing their habit based on what they learned.

Intervention Type BEHAVIORAL

SSI (Single-session intervention (~30 minutes) control arm

The control condition will be matched to the SSI by including both reading and writing exercises. The control intervention will consist of supportive therapy focusing on sharing emotions and include an introduction to emotions, writing about emotions, testimonials from other adolescents about the power of sharing emotions, and an exercise asking adolescents how different situations might make them feel.

Intervention Type BEHAVIORAL

End-of-Intervention Questionnaires (~5 minutes)

Participants will complete additional questionnaires at the end of the intervention, including acceptability ratings and program feedback. Participants will provide an email address at the end of the questionnaires for receipt of four-week follow-up questionnaires.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* EAT-26 score ≥ 20 ( EAT-26, participants will meet the "referral criteria" which includes a score of 20 or more or meeting frequency criteria on bingeing, purging, laxative/diuretic use, and/or exercise.)
* English-language fluency, self-reported3
* Access to a phone, tablet, or computer

Exclusion Criteria

* Failure to correctly complete one of the attention checks in the survey prior to the intervention
* Failure to correctly complete both anagram tasks in the survey prior to the intervention
* Completion of the screening survey or pre-intervention surveys in an improbably fast time
Minimum Eligible Age

18 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eating Disorders Association

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Courtney Breiner

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Courtney Breiner

Role: CONTACT

518-376-2543

Facility Contacts

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Courtney Breiner

Role: primary

518-376-2543

Other Identifiers

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FP00023118

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HM20030734

Identifier Type: -

Identifier Source: org_study_id

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