Clinical trial NCT05490615: The Virtual Mindfulness Study
Official title: Virtual Mindfulness for Autistic Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Survey Evaluation: All participants will provide pre, post and follow-up survey data related to either a 6-week virtual mindfulness course or waitlist. Participants will fill out survey measures evaluating the impact of either the intervention or waitlist on distress levels, self-compassion, mindfulness, and connections from baseline (Time 1) to week 7 (Time 2) and week 15 (Time 3). In addition, the waitlist control group (Group B) will be offered virtual mindfulness intervention from week 16 to week 21 and will be asked to complete 2 additional set of questionnaires at week 22 and at week 30, thus providing data pre and post with follow-up related to the mindfulness intervention.

Study Setting: This study will be delivered virtually but will be offered through CAMH, Toronto.

Target Population We aim to recruit in total 80 autistic adults from across Canada.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years and older;
* Autistic
* Proficient in English;
* Able to independently complete survey questionnaires;
* Able to independently participate in an online based group;
* Access to internet and computer/tablet

Exclusion Criteria:

* Presence of intellectual disability;
* Unable to comprehend English or speak or write in English;
* No access to internet and computer/tablet.

Primary outcomes:
measure: Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
timeFrame: Baseline or enrolment (Group-A and Group B)
measure: Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
timeFrame: 7 Weeks (Group-A and Group B)
measure: Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
timeFrame: 15 Weeks (Group-A and Group B)
measure: Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
timeFrame: 22 Weeks (Group-B)
measure: Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
timeFrame: 30 Weeks (Group-B)
Secondary outcomes:
measure: Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)
timeFrame: Baseline/enrolment (Group-A and Group B)
measure: Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)
timeFrame: 7 week (Group-A and Group B)
measure: Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)
timeFrame: 15 Week (Group-A and Group B)
measure: Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)
timeFrame: 22 Week (Group B)
measure: Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)
timeFrame: 30 Week (Group B)
measure: Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)
timeFrame: Baseline/enrolment (Group-A and Group B)
measure: Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)
timeFrame: 7 week (Group-A and Group B)
measure: Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)
timeFrame: 15 Week (Group-A and Group B)
measure: Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)
timeFrame: 22 Week (Group B)
measure: Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)
timeFrame: 30 Week (Group B)
measure: Autistic Participant Satisfaction-measured using Intervention Satisfaction Scale (ISS)
timeFrame: 7 Week (Group-A)
measure: Autistic Participant Satisfaction-measured using Intervention Satisfaction Scale (ISS)
timeFrame: 22 Week (Group B)
measure: Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)
timeFrame: Baseline/ enrolment (Group-A and Group B)
measure: Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)
timeFrame: 7 Week (Group-A and Group B)
measure: Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)
timeFrame: 15 Week (Group-A and Group B)
measure: Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)
timeFrame: 22 Week (Group B)
measure: Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)
timeFrame: 30 Week (Group B)
measure: Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)
timeFrame: Baseline (Group-A and Group B)
measure: Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)
timeFrame: 7 Week (Group-A and Group B)
measure: Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)
timeFrame: 15 Week (Group-A and Group B)
measure: Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)
timeFrame: 22 Week (Group B)
measure: Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)
timeFrame: 30 Week (Group B)
measure: Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS
timeFrame: Baseline (Group-A and Group B)
measure: Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS
timeFrame: 7 Week (Group-A and Group B)
measure: Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS
timeFrame: 15 Week (Group-A and Group B)
measure: Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS
timeFrame: 22 Week (Group B)
measure: Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS
timeFrame: 30 Week (Group B)
measure: Follow-up Satisfaction Form
timeFrame: End of the Study
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: CAMH
state: Ontario
Study officials:
affiliation: CAMH
name: Yona Lunsky, PhD
role: PRINCIPAL_INVESTIGATOR
References: