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

NCT05799872 | Recruiting

• 2 other identifiers: HM20025847R34MH129464
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to End of treatment (week 24)

Secondary Outcomes (3)

• Change in Depressive Symptoms

  Baseline to End of treatment (week 24)

• Change in Anxiety Symptoms

  Baseline to End of treatment (week 24)

• Change in Suicidal Ideation

  Baseline to End of treatment (week 24)

Study Arms (2)

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)

Interventions

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

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

Psychoeducational and Behavioral Therapy (PBT) 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.

Psychoeducational and Behavioral Therapy (PBT):

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ann Haynos, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kira Venables

CONTACT

(804)828-2658; venableskg@vcu.edu

Ann Haynos, PhD

CONTACT

(804)828-1193; haynosa@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: April 5, 2023
• Study Start: December 6, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Descriptive/raw research data will be made available for access to other researchers within four (4) months after submission.

Locations

US (1)