Eating Disorder Not Otherwise SpecifiedNCT06861608
A Single-session Intervention Adaptation of the Habit Framework for the Prevention of Eating Disorders
A study testing Screening Questionnaire, Pre-Intervention Questionnaires (~10 minutes) and SSI (Single-session intervention (~30 minutes) Active arm in people with Eating Disorder Not Otherwise Specified, run by Virginia Commonwealth University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 22 years
- Conditions the study is for
- Eating Disorder Not Otherwise Specified
- What is being tested?
- Screening Questionnaire, Pre-Intervention Questionnaires (~10 minutes) and SSI (Single-session intervention (~30 minutes) Active arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 22 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Courtney Breiner, 518-376-2543, breinerc@vcu.edu
Courtney Breiner
About this study
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).
Read the detailed description
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
- Eating Disorder Not Otherwise Specified
- Being tested
- 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)
- Keywords
- prevention of eating disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening QuestionnaireBehavioural
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)Behavioural
Eligible participants will complete pre-intervention questionnaires including demographics and symptom measures.
SSI (Single-session intervention (~30 minutes) Active armBehavioural
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 armBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: psychoeducation experience single-session intervention (SSI) | Experimental | 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. Receives: Behavioral: Screening Questionnaire; Behavioral: Pre-Intervention Questionnaires (~10 minutes); Behavioral: SSI (Single-session intervention (~30 minutes) Active arm; Behavioral: End-of-Intervention Questionnaires (~5 minutes) |
| Control: will be matched to the SSI by including both reading and writing exercises. | Placebo comparator | 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. Receives: Behavioral: Screening Questionnaire; Behavioral: Pre-Intervention Questionnaires (~10 minutes); Behavioral: SSI (Single-session intervention (~30 minutes) control arm; Behavioral: End-of-Intervention Questionnaires (~5 minutes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Attitudes Test - 26-item
This 26-item measure will be used to assess eating disorder, including bingeing, purging, and exercise behaviors. According to this methodology, individuals who score 20 or more on the test should be interviewed by a qualified professional to determine if they meet the diagnostic criteria for an eating disorder. If you have a low score on the EAT-26 (below 20), you still could have a serious eating problem, so do not let the results deter you from seeking help. For example, some individuals with Binge Eating Disorder (BED) score low on the EAT-26 but may have a serious eating disorder.
Measured: Baseline though study completion and up to one month follow-up
The Brief (Seven-item) Eating Disorder Examination Questionnaire
This measure will be used to assess eating behaviors over the past month. The seven-item version consists of seven items derived from the original Eating Disorder Examination Questionnaire and assesses for dietary restraint, shape/weight overvaluation, and body dissatisfaction. It consists of three subscales: dietary restraint (items 1, 3 and 4), shape/weight overvaluation (items 22 and 23) and body dissatisfaction (items 25 and 26).
Measured: Baseline though study completion and up to one month follow-up
Self-report Habit Index
The self-report habit index measures habit strength, which is the underlying mechanism being targeted in the current intervention. 7-point Likert scale from "strongly disagree" to "strongly agree." Higher scores indicate a stronger habit, suggesting the behavior is more automatic and less consciously controlled.
Measured: Baseline though study completion and up to one month follow-up
State Hope Scale - Agency Subscale
The 3-item agency subscale of the State Hope Scale measures belief in one's capacity to initiate and sustain actions. Research has shown that high agency is predictive of goal-related activities and utilization of coping skills. Higher scores on the agency subscale generally indicate a stronger sense of personal agency and belief in one's ability to take control and actively pursue goals.
Measured: Baseline though study completion and up to one month follow-up
Beck Hopelessness Scale - 4-item Version
This 4-item measure assesses hopelessness about the future with excellent psychometric properties and good internal consistency. typically calculated by summing up the responses to the four selected items, with a potential range from 0 to 4, where higher scores indicate greater levels of hopelessness.
Measured: Baseline though study completion and up to one month follow-up
Barriers to Seeking Treatment.
Help-seeking barriers will be assessed using this 26-item measure that was created in alignment with results of a systematic review of barriers and facilitators to help-seeking in eating disorders. A high score on a barrier-to-treatment scale suggests that the individual perceives that particular factor as a significant obstacle to seeking professional help.
Measured: Baseline though study completion and up to one month follow-up
SSI
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 based on what participants learned throughout the intervention. 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 through each aspect of changing their habit based on what they learned.
Measured: Baseline though study completion and up to one month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start15 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Disorder Not Otherwise SpecifiedStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eating Disorders Association
- Responsible party
- Sponsor
- Investigators
- Courtney Breiner, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861608
- Sponsor's protocol ID
- HM20030734
- Other IDs
- FP00023118
- Status last verified
- Aug 2026
- First submitted
- 27 Jan 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-session Intervention Adaptation of the Habit Framework for the Prevention of Eating Disorders
- ClinicalTrials.gov ID
- NCT06861608
- Acronym / sponsor ID
- HM20030734
- Conditions
- Eating Disorder Not Otherwise Specified
- Keywords
- prevention of eating disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Eating Disorders Association
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Mar 2025 (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 this proposal is to launch the first trial of a single-session intervention (SSI) specifically for the prevention of eating disorders (EDs).
Detailed description
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental: psychoeducation experience single-session intervention (SSI) | Experimental | Behavioral: Screening Questionnaire, Behavioral: Pre-Intervention Questionnaires (~10 minutes), Behavioral: SSI (Single-session intervention (~30 minutes) Active arm, Behavioral: End-of-Intervention Questionnaires (~5 minutes)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. |
| Control: will be matched to the SSI by including both reading and writing exercises. | Placebo comparator | Behavioral: Screening Questionnaire, Behavioral: Pre-Intervention Questionnaires (~10 minutes), Behavioral: SSI (Single-session intervention (~30 minutes) control arm, Behavioral: End-of-Intervention Questionnaires (~5 minutes)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. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Screening QuestionnaireIndividuals 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. | Behavioural | Control: will be matched to the SSI by including both reading and writing exercises., Experimental: psychoeducation experience single-session intervention (SSI) |
| Pre-Intervention Questionnaires (~10 minutes)Eligible participants will complete pre-intervention questionnaires including demographics and symptom measures. | Behavioural | Control: will be matched to the SSI by including both reading and writing exercises., Experimental: psychoeducation experience single-session intervention (SSI) |
| SSI (Single-session intervention (~30 minutes) Active armThe 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. | Behavioural | Experimental: psychoeducation experience single-session intervention (SSI) |
| SSI (Single-session intervention (~30 minutes) control armThe 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. | Behavioural | Control: will be matched to the SSI by including both reading and writing exercises. |
| 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. | Behavioural | Control: will be matched to the SSI by including both reading and writing exercises., Experimental: psychoeducation experience single-session intervention (SSI) |
Primary outcome
Eating Attitudes Test - 26-item
Time frame: Baseline though study completion and up to one month follow-up
This 26-item measure will be used to assess eating disorder, including bingeing, purging, and exercise behaviors. According to this methodology, individuals who score 20 or more on the test should be interviewed by a qualified professional to determine if they meet the diagnostic criteria for an eating disorder. If you have a low score on the EAT-26 (below 20), you still could have a serious eating problem, so do not let the results deter you from seeking help. For example, some individuals with Binge Eating Disorder (BED) score low on the EAT-26 but may have a serious eating disorder.
The Brief (Seven-item) Eating Disorder Examination Questionnaire
Time frame: Baseline though study completion and up to one month follow-up
This measure will be used to assess eating behaviors over the past month. The seven-item version consists of seven items derived from the original Eating Disorder Examination Questionnaire and assesses for dietary restraint, shape/weight overvaluation, and body dissatisfaction. It consists of three subscales: dietary restraint (items 1, 3 and 4), shape/weight overvaluation (items 22 and 23) and body dissatisfaction (items 25 and 26).
Self-report Habit Index
Time frame: Baseline though study completion and up to one month follow-up
The self-report habit index measures habit strength, which is the underlying mechanism being targeted in the current intervention. 7-point Likert scale from "strongly disagree" to "strongly agree." Higher scores indicate a stronger habit, suggesting the behavior is more automatic and less consciously controlled.
State Hope Scale - Agency Subscale
Time frame: Baseline though study completion and up to one month follow-up
The 3-item agency subscale of the State Hope Scale measures belief in one's capacity to initiate and sustain actions. Research has shown that high agency is predictive of goal-related activities and utilization of coping skills. Higher scores on the agency subscale generally indicate a stronger sense of personal agency and belief in one's ability to take control and actively pursue goals.
Beck Hopelessness Scale - 4-item Version
Time frame: Baseline though study completion and up to one month follow-up
This 4-item measure assesses hopelessness about the future with excellent psychometric properties and good internal consistency. typically calculated by summing up the responses to the four selected items, with a potential range from 0 to 4, where higher scores indicate greater levels of hopelessness.
Barriers to Seeking Treatment.
Time frame: Baseline though study completion and up to one month follow-up
Help-seeking barriers will be assessed using this 26-item measure that was created in alignment with results of a systematic review of barriers and facilitators to help-seeking in eating disorders. A high score on a barrier-to-treatment scale suggests that the individual perceives that particular factor as a significant obstacle to seeking professional help.
SSI
Time frame: Baseline though study completion and up to one month follow-up
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 based on what participants learned throughout the intervention. 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 through each aspect of changing their habit based on what they learned.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Courtney Breiner principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening Questionnaire, Pre-Intervention Questionnaires (~10 minutes) and SSI (Single-session intervention (~30 minutes) Active arm in people with Eating Disorder Not Otherwise Specified, run by Virginia Commonwealth 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Breiner (518-376-2543, breinerc@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Attitudes Test - 26-item (time frame: Baseline though study completion and up to one month follow-up). The study lists 7 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 5 Aug 2026.