Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Positive Affect Treatment for Anorexia Nervosa (PAT-AN):, Psychoeducational and Behavioral Therapy (PBT).
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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 a - 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.
Primary outcome measures
- Change in Body Mass Index (BMI) from Baseline to End of Treatment [Time frame: Baseline to End of treatment (week 24)]
- Change in Eating Disorder Symptoms [Time frame: Baseline to End of treatment (week 24)]
Secondary outcome measures (3)
- 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)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Virginia Commonwealth University — Richmond
Identifiers
NCT: NCT05799872 · HM20025847 · R34MH129464