Clinical trial NCT05799872: Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
Official title: Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-04-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Body Mass Index (BMI) from Baseline to End of Treatment
timeFrame: Baseline to End of treatment (week 24)
measure: Change in Eating Disorder Symptoms
timeFrame: Baseline to End of treatment (week 24)
Secondary outcomes:
measure: Change in Depressive Symptoms
timeFrame: Baseline to End of treatment (week 24)
measure: Change in Anxiety Symptoms
timeFrame: Baseline to End of treatment (week 24)
measure: Change in Suicidal Ideation
timeFrame: Baseline to End of treatment (week 24)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Principal Investigator
name: Ann Haynos, PhD
role: PRINCIPAL_INVESTIGATOR
References: