Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults

Обзор

Autistic adults are at a greater risk for mental health problems compared to the general population, with 50% meeting criteria for a co-occurring psychiatric condition. Depression and anxiety are the most common of these conditions among autistic adults, contributing to long-term detrimental effects on health, day-to-day functioning, and quality of life. This study will conduct the first large-scale head-to-head comparison of the two most widely studied mental health interventions for autistic adults: cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT). Both interventions are well-established, empirically supported treatments for depression and anxiety in the general population, and both interventions have demonstrated efficacy among autistic adults. However, their comparative effectiveness and heterogeneity of treatment effects have not been established in autistic adults. Both interventions will be delivered by telehealth.

Подробное описание

This study includes three aims:

Aim 1. Evaluate the effectiveness of two different mental health interventions, CBT versus MBT, to improve patient-centered mental health outcomes, quality of life, well-being, and functional impairment among autistic adults with co-occurring anxiety and/or depressive disorders.

Aim 2. Explore patient characteristics (e.g., expressive language ability, intellectual ability, alexithymia, sensory sensitivity) that may moderate the relationship between CBT or MBT and patient outcomes.

Aim 3. Compare implementation outcomes of acceptability and feasibility of CBT relative to MBT as reported by patients and clinicians using mixed methods.

Вмешательства

• Поведенческое Cognitive-Behavioral Therapy (CBT)
  The UP incorporates common principles among empirically supported CBT protocols, including restructuring maladaptive cognitions, changing maladaptive behaviors, preventing emotion avoidance, and incorporating exposure. It consists of five core treatment modules: 1. emotion awareness, 2. cognitive appraisal \& reappraisal, 3. emotion avoidance \& emotion-driven behaviors, 4. awareness and tolerance of emotion-related physical sensations, \& 5. interoceptive and situational emotion-focused exposu
• Поведенческое Mindfulness-Based Cognitive Therapy (MBCT)
  The study MBCT protocol is a 9-week program (90-120 minute sessions) with home-based practice between sessions. MBCT sessions incorporate formal mindfulness meditation practices such as sitting meditation, mindful movement, and body scan (with a focus on mindful and non-judgmental attention to sensations, thoughts, and feelings), as well as informal practices and homework to integrate mindful awareness into everyday life, such as mindful eating, mindful walking, and mindful breathing. All sessio

Первичные конечные точки

• Change in anxiety and depression symptoms [Срок оценки: Baseline, up to 18 weeks]

Вторичные конечные точки (10)

• Change in mental health [Срок оценки: Baseline through 6 months of follow-up]
• Change in psychiatric diagnosis [Срок оценки: Baseline through 6 months of follow-up]
• Change in quality of life [Срок оценки: Baseline through 6 months of follow-up]
• Change in well-being [Срок оценки: Baseline through 6 months of follow-up]
• Change in self-acceptance [Срок оценки: Baseline through 6 months of follow-up]
• Change in functional impairment [Срок оценки: Baseline through 6 months of follow-up]
• Change in disability [Срок оценки: Baseline through 6 months of follow-up]
• Potential Negative Effects of Intervention [Срок оценки: Up to 6-months follow-up]
• Intervention services satisfaction [Срок оценки: Up to 18 weeks]
• Intervention therapist and therapy satisfaction [Срок оценки: Up to 18 weeks]

Критерии участия

Критерии включения

• ≥18 years of age
• Co-occurring depression and/or anxiety as determined by a total score ≥10 on the PHQ-ADS
• Living in North Carolina or Virginia
• Ability to participate in therapy sessions over telehealth
• English-speaking
• Provide proof of a professional diagnosis of autism OR meet or exceed clinical cut-off on the Social Responsiveness Scale (SRS-2) autism screening instrument

Критерии исключения

• Altered mental status that precludes the ability to provide informed assent or consent (acute psychosis, intoxication, or mania)
• Imminent risk of suicide

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

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of North Carolina at Chapel Hill — Chapel Hill
• University of Virginia — Charlottesville

Идентификаторы

NCT: NCT06060860 · 23-0871

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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