Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
- Conditions
- Anorexia Nervosa
- Interventions
- Behavioral: Psychoeducational and Behavioral Therapy (PBT)
- Registration Number
- NCT05799872
- Lead Sponsor
- Virginia Commonwealth University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psychoeducational and Behavioral Therapy (PBT): Psychoeducational and Behavioral Therapy (PBT) -
- Primary Outcome Measures
Name Time Method Change in Eating Disorder Symptoms Baseline to End of treatment (week 24) 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.
Change in Body Mass Index (BMI) from Baseline to End of Treatment Baseline to End of treatment (week 24) 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.
- Secondary Outcome Measures
Name Time Method Change in Anxiety Symptoms Baseline to End of treatment (week 24) The Depression, Anxiety, and Stress Scale-21 is a self-report measure that will assess anxiety symptom severity. The anxiety subscale consists of 7 items rated from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores on the DASS-21 anxiety subscale range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Change in Depressive Symptoms Baseline to End of treatment (week 24) The Depression, Anxiety, and Stress Scale-21 is a self-report measure that will assess depressive symptom severity. The depression subscale consists of 7 items rated from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Scores on the DASS-21 depression subscale range from 0 to 21, with higher scores indicating greater depressive symptom severity.
Change in Suicidal Ideation Baseline to End of treatment (week 24) The Columbia - Suicide Severity Rating Scale (C-SSRS) is an interview-based measure assessing the presence and intensity of suicidal ideation and the presence of suicidal behavior. The C-SSRS will be used to determine if treatment impacts suicidal ideation. Intensity of suicidal ideation is rated from 0-5, with higher scores indicating more severe suicidal ideation.
Trial Locations
- Locations (1)
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States