Relapse Prevention and Changing Habits in Anorexia Nervosa

Официальное название

Optimizing Relapse Prevention and Changing Habits in Anorexia Nervosa

Обзор

This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the Preparation Phase, we examined accessibility and feasibility of the treatment package. In the current Optimization Phase, we will identify which components of treatment contribute to positive outcomes after acute hospitalization. We will carefully evaluate maintenance of remission, measured by rate of weight loss and end-of-trial status.

Подробное описание

While many approaches to reducing relapse after hospital care have been tried, there is little information about which treatment elements confer benefit. This trial, Relapse Prevention and Changing Habits (REACH+), targets the habitual control of maladaptive behavior to support patients with AN in the 6 months after acute treatment, a time of high vulnerability to relapse. Each component of REACH+ addresses a question that is critical to answer in order to identify and optimize a relapse prevention treatment package that balances efficacy and burden. We will test the acceptability and feasibility of 5 components that together target habits: 1) Behavioral, 2) Cognitive, 3)Motivation, 4) Food Monitoring, and 5) Skill Consolidation. In the Preparation Phase, 10 participants were enrolled, and accessibility and feasibility of the treatment package was examined. The current Optimization Phase includes a finalized treatment manual (including an online platform) and will test each component's contribution to weight maintenance after acute treatment.

Вмешательства

• Поведенческое Relapse Prevention and Changing Habits (REACH+)
  Psychotherapy

Первичные конечные точки

• Weight maintenance [Срок оценки: 6-month end of treatment]

Вторичные конечные точки (5)

• Habit strength [Срок оценки: 6-month end of treatment]
• Weight/shape distortion [Срок оценки: 6-month end of treatment]
• Intrinsic motivation [Срок оценки: 6-month end of treatment]
• Dietary restriction [Срок оценки: 6-month end of treatment]
• Skill consolidation [Срок оценки: 6-month end of treatment]

Критерии участия

Критерии включения

• Diagnosis of Anorexia Nervosa at hospital admission
• Medically Stable
• Internet capability with videoconferencing
• Weight restored (BMI > 19 kg/m2) at New York State Psychiatric Institute

Критерии исключения

• Current substance use or other comorbid disorder requiring specialized treatment
• Pregnancy
• Imminent risk of suicide
• Serious medical illness
• Daily psychotropic medication other than antidepressants (medications that are known effect weight are exclusionary, i.e. stimulants, olanzapine, mirtazapine)
• Participation in outside psychotherapy or structured treatment program (support groups will be allowed). Individuals who are discharged on medications would need to have a non-study psychiatrist.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• New York State Psychiatric Institute — New York

Публикации

• Steinglass JE, Attia E, Glasofer DR, Wang Y, Ruggiero J, Walsh BT, Thomas JG. Optimizing relapse prevention and changing habits (REACH+) in anorexia nervosa. Int J Eat Disord. 2022 Jun;55(6):851-857. doi: 10.1002/eat.23724. Epub 2022 Apr 30. PMID 35488866

Идентификаторы

NCT: NCT04810624 · 8110 · R34MH127180

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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