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

NCT05799872 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-05

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Ann Haynos, PhD · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2026-07-30
Completion
2026-10-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05799872 on ClinicalTrials.gov