Recruiting

Habit Framework

Sponsor:

Virginia Commonwealth University

Code:

NCT06861608

Conditions

Eating Disorder Not Otherwise Specified

Eligibility Criteria

Sex: All

Age: 18 - 22

Healthy Volunteers: Not accepted

Interventions

Screening Questionnaire

Pre-Intervention Questionnaires (~10 minutes)

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

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

End-of-Intervention Questionnaires (~5 minutes)

Study Details

Brief summary:

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).

Conditions

Eating Disorder Not Otherwise Specified

Study ID

NCT06861608

Start date

Jan 15, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 22

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

Interventions

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.

Pre-Intervention Questionnaires (~10 minutes)

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

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.

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.

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.

Primary outcome measure

  • Eating Attitudes Test - 26-item [ Time Frame: Baseline though study completion and up to one month follow-up ]
  • The Brief (Seven-item) Eating Disorder Examination Questionnaire [ Time Frame: Baseline though study completion and up to one month follow-up ]
  • Self-report Habit Index [ Time Frame: Baseline though study completion and up to one month follow-up ]
  • State Hope Scale - Agency Subscale [ Time Frame: Baseline though study completion and up to one month follow-up ]
  • Beck Hopelessness Scale - 4-item Version [ Time Frame: Baseline though study completion and up to one month follow-up ]
  • Barriers to Seeking Treatment. [ Time Frame: Baseline though study completion and up to one month follow-up ]
  • SSI [ Time Frame: Baseline though study completion and up to one month follow-up ]

Central Contacts and Locations

Central contacts

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Courtney Breiner

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • prevention of eating disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-08-05.