Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Change in anxiety and depression symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •Altered mental status that precludes the ability to provide informed assent or consent (acute psychosis, intoxication, or mania)
- •Imminent risk of suicide
结局指标
主要结局
Change in anxiety and depression symptoms
时间窗: Baseline, up to 18 weeks
The Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) is a 16-item composite measure that provides a single composite score for depression and anxiety. It comprises the 9-item Patient Health Questionnaire depression scale (PHQ-9) and the 7-item Generalized Anxiety Disorder scale (GAD-7). PHQ-ADS scores can range from 0 to 48 with higher scores indicating more severe depression/anxiety.
次要结局
- Change in quality of life(Baseline through 6 months of follow-up)
- Potential Negative Effects of Intervention(Up to 6-months follow-up)
- Change in mental health(Baseline through 6 months of follow-up)
- Change in disability(Baseline through 6 months of follow-up)
- Intervention services satisfaction(Up to 18 weeks)
- Intervention therapist and therapy satisfaction(Up to 18 weeks)
- Change in psychiatric diagnosis(Baseline through 6 months of follow-up)
- Change in well-being(Baseline through 6 months of follow-up)
- Change in self-acceptance(Baseline through 6 months of follow-up)
- Change in functional impairment(Baseline through 6 months of follow-up)