Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa

NCT ID: NCT05799872

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-06
• Study Completion Date: 2026-10-30

Brief 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). 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Positive Affect Treatment for Anorexia Nervosa (PAT-AN):

Group Type: EXPERIMENTAL

Positive Affect Treatment for Anorexia Nervosa (PAT-AN):

Intervention Type: BEHAVIORAL

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):

Group Type: ACTIVE_COMPARATOR

Psychoeducational and Behavioral Therapy (PBT)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age > or = 18 years old

2. Ability to read and speak in English

3. DSM-5 diagnosis of AN or atypical AN at admission to higher-level care

4. In higher-level care discharging to outpatient care or discharged to outpatient care within the past 3 months

5. Current BMI > or = 18.5 kg/m2 (or will be by time of discharge)

6. BMI increase of > or = 0.5 kg/m2 while in higher-level care

7. Ability to designate and sign a release of information for a primary physical or mental health provider for study duration

8. Willingness to participate in weekly assessments (e.g., weight monitoring) and audio or video recording of study therapy sessions for study duration

9. Access to a smartphone and/or computer permitting engagement in remote therapy and assessment.

Exclusion Criteria

1. Medical instability for outpatient care;

2. Pregnancy

3. Lifetime DSM-5 primary psychotic or bipolar-I disorder

4. Current DSM-5 substance use disorder

5. Enrollment in outpatient therapy with highly overlapping content to PAT-AN

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Haynos, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kira Venables

Role: CONTACT

venableskg@vcu.edu

(804)828-2658

Ann Haynos, PhD

Role: CONTACT

haynosa@vcu.edu

(804)828-1193

Other Identifiers

R34MH129464

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20025847

Identifier Type: -

Identifier Source: org_study_id