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临床试验/NCT05880498
NCT05880498已完成不适用

Smartphone Mindfulness Autism Research Team Study

Massachusetts Institute of Technology2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2022年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
2
主要终点
State-Trait Anxiety Inventory for Adults

研究概览

简要总结

Individuals diagnosed with autism are also often diagnosed with anxiety disorders. Therefore, having useful strategies to manage stress and anxiety may be particularly helpful for autistic individuals. Mindfulness-based interventions, delivered in-person as well as those offered remotely online, have been found to lower stress and anxiety. Although in-person mindfulness training has been found to be helpful for autistic individuals, there is little research that has studied remote app-based mindfulness training in autistic adults.

This study examines whether a six-week structured intervention, using a mindfulness app, lowers anxiety and stress in autistic adults. Participants were randomly assigned either to an intervention group, which started the intervention immediately, or a wait-list control group, which participated in the same intervention program six-weeks later. Findings will provide important information about the potential for remote app-based mindfulness training to lower stress and anxiety in adults diagnosed with autism.

详细描述

A significant proportion of individuals diagnosed with autism are also diagnosed with one or more anxiety disorders. Since stress and anxiety in autism have been found to exacerbate common symptoms associated with autism, such as sleep problems and sensory sensitivities, having effective strategies to manage anxiety and stress may be particularly beneficial for autistic individuals. Mindfulness-based therapies have been increasingly recognized as promising interventions to reduce stress and anxiety, and improve mental health in individuals with and without autism. Several studies of individuals without autism have demonstrated that remote digital mindfulness training is equally as effective as traditional in-person mindfulness training in reducing stress and anxiety and enhancing well-being. However, there is little research investigating remote app-based mindfulness training for autistic individuals, which could be especially beneficial with this population due to anxiety and other constraints that make in-person training less feasible.

The primary objective is to assess efficacy of a six-week remote self-guided mindfulness intervention in reducing anxiety and stress in autistic adults. Autistic adults were invited to participate in a remote app-based mindfulness study where participants use their smartphones to complete the six-week structured mindfulness intervention. Participants were block randomized (based on initial trait anxiety scores) to either an intervention group or a wait-list control group. The intervention group immediately received the online mindfulness intervention. The wait-list control group received the same intervention program six-weeks later. All sessions and assessments were delivered online; thus participants were allowed maximal flexibility in participating in this fully remote intervention.

Self-reported levels of stress, anxiety, positive and negative emotions, and trait/dispositional mindfulness were measured at four time-points throughout the study: before the intervention, half-way through (at 3 weeks), after the intervention, and at follow-up (6 weeks after the end of the intervention). The wait-list control group was assessed at two additional time-points: before they began their waiting period and half-way through their waiting period (at 3 weeks). The primary aim of the study is to compare between-group (and secondarily, within-group) outcome measures to determine whether stress and anxiety levels decrease after the mindfulness intervention and whether they decrease above and beyond any decreases experienced by the wait-list control group.

Additionally, the study aims to:

  • Determine whether and how changes in mindfulness are associated with changes in anxiety and stress, over the course of the intervention, including whether there is a negative association of mindfulness with stress and anxiety. In using two different measures of mindfulness the specific components of mindfulness can be examined that appear to be most likely to change and most likely to be (negatively) associated with stress and anxiety.
  • Assess the feasibility of such a remote intervention with this sample of autistic adults by examining:

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Daily access to smartphone
  • Professional diagnosis of autism spectrum disorder

排除标准

  • Non-corrected hearing impairment (if it impacts their ability to listen to the app)
  • Far below average nonverbal intellectual ability: 2 standard deviations below the mean on the Test My Brain, matrix reasoning subtest (a validated and normed proxy for nonverbal IQ)
  • Listening comprehension skills that may compromise one's ability to understand the lessons and practices in the app: Below 60% correct on the Listening Comprehension measure (created for this study, based on language used in the Healthy Minds app)
  • Ever taken part in a meditation retreat
  • Engaged in meditation practice at least once per week over the past year
  • Used Healthy Minds app ever
  • Prior training with a meditation teacher (other than an introductory course)
  • Practiced meditation daily for the past 6 months

结局指标

主要结局

State-Trait Anxiety Inventory for Adults

时间窗: 6 Weeks

40-item self-report assessing both state anxiety (20 items) and trait anxiety (20 items) on a 4-point Likert scale. Total trait anxiety scores range from 20 to 80. Total state anxiety scores range from 20 to 80. Higher scores are indicative of a greater level of anxiety.

Patient-Reported Outcomes Measurement Information System [PROMIS] Anxiety Short Form

时间窗: 6 weeks

8-item self-report measure of anxiety, on a 5-point Likert scale. Raw scores range from 8 to 40, with higher scores indicating more anxiety.

次要结局

  • State-Trait Anxiety Inventory for Adults(12 Weeks)
  • Perceived Stress Scale(12 weeks)
  • Positive and Negative Affect Schedule, Short Form(12 weeks)
  • Patient-Reported Outcomes Measurement Information System [PROMIS] Anxiety Short Form(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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