Anorexia NervosaNCT05799872
Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
A study testing Positive Affect Treatment for Anorexia Nervosa (PAT-AN): and Psychoeducational and Behavioral Therapy (PBT) in people with Anorexia Nervosa, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The investigators will recruit individuals with broadly-defined AN (n = 80) who are currently in or have recently participated in higher-level eating disorder treatment (e.g., residential, partial hospitalization/day treatment, intensive outpatient treatment). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Positive Affect Treatment for Anorexia Nervosa (PAT-AN): and Psychoeducational and Behavioral Therapy (PBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2023to 31 Aug 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = 18 years old
- Ability to read and speak in English
- DSM-5 diagnosis of AN or atypical AN at admission to higher-level care
- In higher-level care discharging to outpatient care or discharged to outpatient care within the past 3 months
- Current BMI > or = 18.5 kg/m2 (or will be by time of discharge)
- BMI increase of > or = 0.5 kg/m2 while in higher-level care
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- Ability to designate and sign a release of information for a primary physical or mental health provider for study duration
- Willingness to participate in weekly assessments (e.g., weight monitoring) and audio or video recording of study therapy sessions for study duration
- Access to a smartphone and/or computer permitting engagement in remote therapy and assessment.
Who cannot join
- Medical instability for outpatient care;
- Pregnancy
- Lifetime DSM-5 primary psychotic or bipolar-I disorder
- Current DSM-5 substance use disorder
- Enrollment in outpatient therapy with highly overlapping content to PAT-AN
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The investigators will recruit individuals with broadly-defined AN (n = 80) who are currently in or have recently participated in higher-level eating disorder treatment (e.g., residential, partial hospitalization/day treatment, intensive outpatient treatment). Interested participants will sign consent, complete eligibility assessments, and will be randomized to receive Positive Affect Treatment for Anorexia Nervosa (PAT-AN) or Psychoeducation and Behavioral Therapy (PBT) through teletherapy shortly following discharge from higher level of care. Participants can participate in most other forms of outpatient treatment while receiving the research intervention. Participants will engage in 24 weeks of PAT-AN or PBT starting in the first 3 months post-discharge. At each session, the investigators will complete brief measures assessing treatment acceptability, affect, and eating disorder symptoms. Participants will also complete an assessment battery of self-report, EMA, and neurocognitive measures evaluating primary outcomes (BMI; eating disorder symptoms), secondary outcomes (depression, anxiety, and suicidality), and presumed treatment mechanisms at baseline, end of treatment (EOT), and 3-month follow-up (FU). All assessments will be remotely delivered via HIPAA-compliant platforms.
- Conditions
- Anorexia Nervosa
- Being tested
- Positive Affect Treatment for Anorexia Nervosa (PAT-AN):, Psychoeducational and Behavioral Therapy (PBT)
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Affect Treatment for Anorexia Nervosa (PAT-AN):Behavioural
PAT-AN is an adaptation of the cognitive-behavioral outpatient individual therapy for anhedonia (17, 68). The overarching aim of PAT-AN is to enhance reward sensitivity (reward anticipation, experiencing, and learning) to non-eating disorder experiences and to decrease or replace reward sensitivity to weight-loss experiences (26). PAT-AN includes 6 sequential modules, each designated to target specific reward sensitivity disturbances (26, 68). Homework and experiential practice during sessions are essential components of PAT-AN, and participants are provided a workbook to assist with this practice. During each session, collaborative homework review is followed by skill development and homework assignments.
Psychoeducational and Behavioral Therapy (PBT)Behavioural
The comparison treatment is modeled off of educational and behavioral interventions used in prior clinical trials for AN and common elements of standard behavioral eating disorder treatments. The treatment is structured to parallel the modular format of PAT-AN.
| Study group | Role | What they receive |
|---|---|---|
| Positive Affect Treatment for Anorexia Nervosa (PAT-AN): | Experimental | Not described Receives: Behavioral: Positive Affect Treatment for Anorexia Nervosa (PAT-AN): |
| Psychoeducational and Behavioral Therapy (PBT): | Active comparator | Not described Receives: Behavioral: Psychoeducational and Behavioral Therapy (PBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI) from Baseline to End of Treatment
Objective height will be captured through guided measurement at baseline. Objective weight will be measured throughout on a blind smartscale, which will transfer weight data directly to the research team by wireless internet without providing an outward display of weight to participants. Participants will have a smartscale shipped to their home. They will measure their weight at baseline and following treatment on the scale in standard street clothes (no outer garments or shoes) while on a video call with research staff.
Measured: Baseline to End of treatment (week 24)
Change in Eating Disorder Symptoms
The Eating Disorder Examination (EDE) is an investigator-based interview assessing eating disorder psychopathology that will be used as the primary measure of eating disorder symptoms. The EDE has extensive psychometric data to support its reliability and validity. The EDE comprises four subscales: Restraint, Eating Concern, Shape Concern, and Weight Concern. Each question is scored by the interviewer based on frequency over the past month from 0 (symptom not present) to 6 (symptom present every day). Each subscale score is the average of all items in the subscale, while global EDE score is the average of the four subscale scores. Higher EDE scores indicate greater severity and frequency of eating disorder symptoms.
Measured: Baseline to End of treatment (week 24)
Secondary outcomes (3)
Change in Depressive Symptoms
The Depression, Anxiety, and Stress Scale-21 is a self-report measure that will assess depressive symptom severity. The depression subscale consists of 7 items rated from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores on the DASS-21 depression subscale range from 0 to 21, with higher scores indicating greater depressive symptom severity.
Measured: Baseline to End of treatment (week 24)
Change in Anxiety Symptoms
The Depression, Anxiety, and Stress Scale-21 is a self-report measure that will assess anxiety symptom severity. The anxiety subscale consists of 7 items rated from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores on the DASS-21 anxiety subscale range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Measured: Baseline to End of treatment (week 24)
Change in Suicidal Ideation
The Columbia - Suicide Severity Rating Scale (C-SSRS) is an interview-based measure assessing the presence and intensity of suicidal ideation and the presence of suicidal behavior. The C-SSRS will be used to determine if treatment impacts suicidal ideation. Intensity of suicidal ideation is rated from 0-5, with higher scores indicating more severe suicidal ideation.
Measured: Baseline to End of treatment (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start6 Dec 2023
- Primary completion17 Sep 2026
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ann Haynos, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799872
- Sponsor's protocol ID
- HM20025847
- Other IDs
- R34MH129464
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final dataset will include information from self-report questionnaires, clinician-guided interviews, physical assessments, ecological momentary assessment, and neurocognitive tasks. Data will be de-identified and consistent with NDA regulations. Data will be shared via the National Database for Clinical Trials Related to Mental Illness (NDCT) in the NIMH Data Archive (NDA). Established by NIMH, and supported by other Institutes of NIH, the NDA is a secure informatics platform for scientific collaboration and data-sharing. All data will be collected from subjects who have broadly consented to share their data for research use or who have consented to share their data for research, with data use limitations. All de-identified data resulting from this project will be submitted to the NDA at the item level and subject level along with appropriate supporting documentation to enable efficient use of the data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT05799872
- Acronym / sponsor ID
- HM20025847
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 17 Sep 2026 (actual)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Apr 2023 (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 investigators will recruit individuals with broadly-defined AN (n = 80) who are currently in or have recently participated in higher-level eating disorder treatment (e.g., residential, partial hospitalization/day treatment, intensive outpatient treatment). Interested participants will sign consent, complete eligibility assessments, and will be randomized to receive Positive Affect Treatment for Anorexia Nervosa (PAT-AN) or Psychoeducation and Behavioral Therapy (PBT) through teletherapy shortly following discharge from higher level of care. Participants can participate in most other forms of outpatient treatment while receiving the research intervention. Participants will engage in 24 weeks of PAT-AN or PBT starting in the first 3 months post-discharge. At each session, the investigators will complete brief measures assessing treatment acceptability, affect, and eating disorder symptoms. Participants will also complete an assessment battery of self-report, EMA, and neurocognitive measures evaluating primary outcomes (BMI; eating disorder symptoms), secondary outcomes (depression, anxiety, and suicidality), and presumed treatment mechanisms at baseline, end of treatment (EOT), and 3-month follow-up (FU). All assessments will be remotely delivered via HIPAA-compliant platforms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Affect Treatment for Anorexia Nervosa (PAT-AN): | Experimental | Behavioral: Positive Affect Treatment for Anorexia Nervosa (PAT-AN): |
| Psychoeducational and Behavioral Therapy (PBT): | Active comparator | Behavioral: Psychoeducational and Behavioral Therapy (PBT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > or = 18 years old
- Ability to read and speak in English
- DSM-5 diagnosis of AN or atypical AN at admission to higher-level care
- In higher-level care discharging to outpatient care or discharged to outpatient care within the past 3 months
- Current BMI > or = 18.5 kg/m2 (or will be by time of discharge)
Key exclusion criteria (5 listed)
- Medical instability for outpatient care;
- Pregnancy
- Lifetime DSM-5 primary psychotic or bipolar-I disorder
- Current DSM-5 substance use disorder
- Enrollment in outpatient therapy with highly overlapping content to PAT-AN
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 |
|---|---|---|
| Positive Affect Treatment for Anorexia Nervosa (PAT-AN):PAT-AN is an adaptation of the cognitive-behavioral outpatient individual therapy for anhedonia (17, 68). The overarching aim of PAT-AN is to enhance reward sensitivity (reward anticipation, experiencing, and learning) to non-eating disorder experiences and to decrease or replace reward sensitivity to weight-loss experiences (26). PAT-AN includes 6 sequential modules, each designated to target specific reward sensitivity disturbances (26, 68). Homework and experiential practice during sessions are essential components of PAT-AN, and participants are provided a workbook to assist with this practice. During each session, collaborative homework review is followed by skill development and homework assignments. | Behavioural | Positive Affect Treatment for Anorexia Nervosa (PAT-AN): |
| Psychoeducational and Behavioral Therapy (PBT)The comparison treatment is modeled off of educational and behavioral interventions used in prior clinical trials for AN and common elements of standard behavioral eating disorder treatments. The treatment is structured to parallel the modular format of PAT-AN. | Behavioural | Psychoeducational and Behavioral Therapy (PBT): |
Primary outcome
Change in Body Mass Index (BMI) from Baseline to End of Treatment
Time frame: Baseline to End of treatment (week 24)
Objective height will be captured through guided measurement at baseline. Objective weight will be measured throughout on a blind smartscale, which will transfer weight data directly to the research team by wireless internet without providing an outward display of weight to participants. Participants will have a smartscale shipped to their home. They will measure their weight at baseline and following treatment on the scale in standard street clothes (no outer garments or shoes) while on a video call with research staff.
Change in Eating Disorder Symptoms
Time frame: Baseline to End of treatment (week 24)
The Eating Disorder Examination (EDE) is an investigator-based interview assessing eating disorder psychopathology that will be used as the primary measure of eating disorder symptoms. The EDE has extensive psychometric data to support its reliability and validity. The EDE comprises four subscales: Restraint, Eating Concern, Shape Concern, and Weight Concern. Each question is scored by the interviewer based on frequency over the past month from 0 (symptom not present) to 6 (symptom present every day). Each subscale score is the average of all items in the subscale, while global EDE score is the average of the four subscale scores. Higher EDE scores indicate greater severity and frequency of eating disorder symptoms.
3 secondary outcomes
Change in Depressive Symptoms
Time frame: Baseline to End of treatment (week 24)
Change in Anxiety Symptoms
Time frame: Baseline to End of treatment (week 24)
Change in Suicidal Ideation
Time frame: Baseline to End of treatment (week 24)
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 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Final dataset will include information from self-report questionnaires, clinician-guided interviews, physical assessments, ecological momentary assessment, and neurocognitive tasks. Data will be de-identified and consistent with NDA regulations. Data will be shared via the National Database for Clinical Trials Related to Mental Illness (NDCT) in the NIMH Data Archive (NDA). Established by NIMH, and supported by other Institutes of NIH, the NDA is a secure informatics platform for scientific collaboration and data-sharing. All data will be collected from subjects who have broadly consented to share their data for research use or who have consented to share their data for research, with data use limitations. All de-identified data resulting from this project will be submitted to the NDA at the item level and subject level along with appropriate supporting documentation to enable efficient use of the data.
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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.
Ann Haynos, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Affect Treatment for Anorexia Nervosa (PAT-AN): and Psychoeducational and Behavioral Therapy (PBT) in people with Anorexia Nervosa, 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 9 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 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. 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?
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?
Change in Body Mass Index (BMI) from Baseline to End of Treatment (time frame: Baseline to End of treatment (week 24)). The study lists 2 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 27 Oct 2026.