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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Change in Body Mass Index (BMI) from Baseline to End of Treatment [Срок оценки: Baseline to End of treatment (week 24)]
• Change in Eating Disorder Symptoms [Срок оценки: Baseline to End of treatment (week 24)]

Вторичные конечные точки (3)

• Change in Depressive Symptoms [Срок оценки: Baseline to End of treatment (week 24)]
• Change in Anxiety Symptoms [Срок оценки: Baseline to End of treatment (week 24)]
• Change in Suicidal Ideation [Срок оценки: Baseline to End of treatment (week 24)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT05799872 · HM20025847 · R34MH129464

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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