Virtual Mindfulness for Autistic Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
研究概览
简要总结
The purpose of this study is to test the effectiveness of a virtual group mindfulness intervention for autistic adults on their mental health and well-being, compared to a group who has not received the virtual group intervention. Specifically, the investigators will compare change across multiple indicators of mental health and well-being for participants, post-intervention, and at 15 weeks follow-up, to participants in a waitlist control group who have not yet received the intervention.
详细描述
It is well recognized that autistic individuals experience high rates of mental health issues, but that needed mental health services are often inaccessible. There is some evidence to suggest that mindfulness-based therapies may help to reduce some of these challenges for autistic adults. While in person interventions may be helpful, there are also benefits to participating in virtually based interventions, particularly during the pandemic. Virtual groups have the added benefit of not requiring travel for people who have difficulties with travel because of anxiety or financial constraints. For some autistic individuals, virtual engagement can be preferred over in person interactions because of the flexibility that virtual interactions allow (camera on or off, communicating with text or speaking, being able to attend from home in a familiar and comfortable space).
In a prior CAMH led study, the investigators demonstrated that autism-informed adaptations to a standard mindfulness-based virtually delivered group intervention led to self-reported improvements in mindfulness, self-compassion, and distress, with changes maintained at three months follow-up. This prior study lacked a control group, however so it is not known whether the positive impacts reported were specific to the mindfulness-based intervention itself or to other factors. Building on this previous work, there is a need to study whether improvements are also evident when compared to individuals who do not take part in the intervention.
The purpose of this study is to test the effectiveness of a virtual group mindfulness intervention for autistic adults on their mental health and well-being, compared to a group who has not received the virtual group intervention. Specifically, the investigators will compare change across multiple indicators of mental health and well-being for participants, post-intervention, and at 15 weeks follow-up, to participants in a waitlist control group who have not yet received the intervention.
Study Design: Randomized controlled trial with waitlist control.
Hypotheses We expect that participants in the mindfulness-based intervention group will report improvements in self-reported distress (primary outcome), mindfulness, self-compassion, and sense of autistic belonging (secondary outcomes), relative to the waitlist control group, which will be maintained at 15 weeks follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Aged 18 years and older;
- •Proficient in English;
- •Able to independently complete survey questionnaires;
- •Able to independently participate in an online based group;
- •Access to internet and computer/tablet
排除标准
- •Presence of intellectual disability;
- •Unable to comprehend English or speak or write in English;
- •No access to internet and computer/tablet.
研究组 & 干预措施
Mindfulness Intervention (Group-A)
Total length of study for participants in Group-A:15 Week
Six weekly sessions (each 60 minutes in length) of group based virtual mindfulness instruction, co-led by a mindfulness teacher and two autistic adults, following a workbook designed for autistic adults. In between sessions, participants are encouraged to complete homework and keep a record of when they practice formal and informal mindfulness practices. In addition, participants are provided with a link to autism informed mental health resources (https://www.yorku.ca/health/lab/ddmh/am-help/)
干预措施: Virtual Mindfulness (Behavioral)
Waitlist Control (Group-B)
Total length of study for participants in Group-B: 30 Week
A waitlist control group is an ethical alternative to no-treatment control groups when studying psychological and behavioral interventions. This group will have access to intervention at the end of the study as well. All waitlist participants are provided with a link to autism informed mental health resources (https://www.yorku.ca/health/lab/ddmh/am-help/)
结局指标
主要结局
Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
时间窗: 30 Weeks (Group-B)
To assess psychological distress, including a 7-item depression subscale, a 7 -item anxiety subscale, and a 7-item stress subscale, each on a 4-point Likert scale, with higher scores indicating higher levels of distress. Total scores for each subscale range from 0 to 42 (summed numbers in each suscale multiplied by 2).
Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
时间窗: Baseline or enrolment (Group-A and Group B)
To assess psychological distress, including a 7-item depression subscale, a 7 -item anxiety subscale, and a 7-item stress subscale, each on a 4-point Likert scale, with higher scores indicating higher levels of distress. Total scores for each subscale range from 0 to 42 (summed numbers in each subscale multiplied by 2).
Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
时间窗: 7 Weeks (Group-A and Group B)
To assess psychological distress, including a 7-item depression subscale, a 7 -item anxiety subscale, and a 7-item stress subscale, each on a 4-point Likert scale, with higher scores indicating higher levels of distress. Total scores for each subscale range from 0 to 42 (summed numbers in each subscale multiplied by 2).
Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
时间窗: 15 Weeks (Group-A and Group B)
To assess psychological distress, including a 7-item depression subscale, a 7 -item anxiety subscale, and a 7-item stress subscale, each on a 4-point Likert scale, with higher scores indicating higher levels of distress. Total scores for each subscale range from 0 to 42 (summed numbers in each subscale multiplied by 2).
Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
时间窗: 22 Weeks (Group-B)
To assess psychological distress, including a 7-item depression subscale, a 7 -item anxiety subscale, and a 7-item stress subscale, each on a 4-point Likert scale, with higher scores indicating higher levels of distress. Total scores for each subscale range from 0 to 42 (summed numbers in each subscale multiplied by 2).
次要结局
- Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)(30 Week (Group B))
- Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)(30 Week (Group B))
- Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)(30 Week (Group B))
- Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)(30 Week (Group B))
- Autistic Participant Satisfaction-measured using Intervention Satisfaction Scale (ISS)(22 Week (Group B))
- Follow-up Satisfaction Form(End of the Study)
- Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS(30 Week (Group B))
- Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)(Baseline/enrolment (Group-A and Group B))
- Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)(7 week (Group-A and Group B))
- Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)(15 Week (Group-A and Group B))
- Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)(22 Week (Group B))
- Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)(Baseline/enrolment (Group-A and Group B))
- Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)(7 week (Group-A and Group B))
- Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)(15 Week (Group-A and Group B))
- Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)(22 Week (Group B))
- Autistic Participant Satisfaction-measured using Intervention Satisfaction Scale (ISS)(7 Week (Group-A))
- Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)(Baseline/ enrolment (Group-A and Group B))
- Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)(7 Week (Group-A and Group B))
- Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)(15 Week (Group-A and Group B))
- Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)(22 Week (Group B))
- Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)(Baseline (Group-A and Group B))
- Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)(7 Week (Group-A and Group B))
- Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)(15 Week (Group-A and Group B))
- Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)(22 Week (Group B))
- Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS(Baseline (Group-A and Group B))
- Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS(7 Week (Group-A and Group B))
- Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS(15 Week (Group-A and Group B))
- Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS(22 Week (Group B))
研究者
Yona Lunsky
Professor
Centre for Addiction and Mental Health