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

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Anorexia Nervosa

Treatments: Behavioral: Psychoeducational and Behavioral Therapy (PBT); Behavioral: Positive Affect Treatment for Anorexia Nervosa (PAT-AN):

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05799872

R34MH129464 (U.S. NIH Grant/Contract)

HM20025847

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

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

Experimental group

Treatment:

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

Psychoeducational and Behavioral Therapy (PBT):

Active Comparator group

Treatment:

Behavioral: Psychoeducational and Behavioral Therapy (PBT)