The Virtual Mindfulness Study

Overview

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 (Kiep, Spek & Hoeben, 2015; Sizoo & Kuiper, 2017; Spek, van Ham & Nyklíček, 2013). 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 allows (camera on or off, communicating with text or speaking, being able to attend from home in a familiar and comfortable space). This project builds upon lessons learned from our previous study REB 116-2017: 'Mindfulness for Adults with ASD. 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, such as being part of a supportive group of autistic peers (Lunsky et al., 2022). Building on our previous work, there is a need to study whether improvements seen in the 2022 study are also evident when compared to individuals who do not take part in the intervention.

Full Title of Study: “Virtual Mindfulness for Autistic Adults: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2023

Interventions

  • Behavioral: Virtual Mindfulness
    • We have previously developed and tested a virtual mindfulness program. Six 1-hour sessions will be led on WebEx. Focus will be on skill building through the teaching of formal and informal mindfulness practices. The intervention, based on the MBSR curriculum, has been modified to make it more accessible for autistic adults. The curriculum developed for this program was designed with autistic advisors guiding the team on the length of meditations, the language used when giving instructions, and the range of techniques that would be most helpful for autistic adults. Each activity is presented as optional, recognizing that some people may find certain silent sensory experiences too distressing. We will include participation of autistic advisors in sessions, promotion of multiple communication options (text and audio, camera on or off), as well as anonymous polling.

Arms, Groups and Cohorts

  • Experimental: Group-A
    • After informed consent, we will assign participants in a 1:1 ratio to the intervention (Group-A) or control group (Group-B) using REDCap. Participant randomization will be stratified by gender, to ensure approximately equal numbers of men and women in treatment and waitlist groups.
  • No Intervention: Group-B
    • Those randomized to the waitlist control will be provided with links to online autism and mental health resources upon enrolment. 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.

Clinical Trial Outcome Measures

Primary Measures

  • Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
    • Time Frame: Baseline or enrolment
    • 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 anxiety or depression. Total scores for each subscale range from 0 to 42.
  • Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
    • Time Frame: 7 Weeks
    • 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 anxiety or depression. Total scores for each subscale range from 0 to 42.
  • Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
    • Time Frame: 15 Weeks
    • 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 anxiety or depression. Total scores for each subscale range from 0 to 42.
  • Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)
    • Time Frame: 22 Weeks
    • 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 anxiety or depression. Total scores for each subscale range from 0 to 42.

Secondary Measures

  • (i) Autistic Participant Depression and Anxiety: measured using the Depression and Anxiety Stress Scale (DASS-21)
    • Time Frame: Baseline/enrolment
    • To assess anxiety and depression, 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 anxiety or depression. Total scores for each subscale range from 0 to 42.
  • (i) Autistic Participant Depression and Anxiety: measured using the Depression and Anxiety Stress Scale (DASS-21)
    • Time Frame: 7 Week
    • To assess anxiety and depression, 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 anxiety or depression. Total scores for each subscale range from 0 to 42.
  • (i) Autistic Participant Depression and Anxiety: measured using the Depression and Anxiety Stress Scale (DASS-21)
    • Time Frame: 15 Week
    • To assess anxiety and depression, 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 anxiety or depression. Total scores for each subscale range from 0 to 42.
  • (i) Autistic Participant Depression and Anxiety: measured using the Depression and Anxiety Stress Scale (DASS-21)
    • Time Frame: 22 Week
    • To assess anxiety and depression, 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 anxiety or depression. Total scores for each subscale range from 0 to 42.
  • Autistic Participant Self Compassion – measured using Self Compassion Scale-Short Form (SCS-SF)
    • Time Frame: Baseline/enrolment
    • 12-item measure that assesses the ability to demonstrate care and kindness toward oneself, and acceptance of one’s own imperfections. Self-compassion is often a focus of mindfulness-based interventions because of the interrelatedness with state mindfulness (Nef, 2003). Responses will be given using a 5-point Likert scale that ranged from 1 (“Almost never”) to 5 (“Almost always”), yielding a total score between 12 and 60, with higher scores indicating greater self-compassion.
  • Autistic Participant Self Compassion – measured using Self Compassion Scale-Short Form (SCS-SF)
    • Time Frame: 7 week
    • 12-item measure that assesses the ability to demonstrate care and kindness toward oneself, and acceptance of one’s own imperfections. Self-compassion is often a focus of mindfulness-based interventions because of the interrelatedness with state mindfulness (Nef, 2003). Responses will be given using a 5-point Likert scale that ranged from 1 (“Almost never”) to 5 (“Almost always”), yielding a total score between 12 and 60, with higher scores indicating greater self-compassion.
  • Autistic Participant Self Compassion – measured using Self Compassion Scale-Short Form (SCS-SF)
    • Time Frame: 15 Week
    • 12-item measure that assesses the ability to demonstrate care and kindness toward oneself, and acceptance of one’s own imperfections. Self-compassion is often a focus of mindfulness-based interventions because of the interrelatedness with state mindfulness (Nef, 2003). Responses will be given using a 5-point Likert scale that ranged from 1 (“Almost never”) to 5 (“Almost always”), yielding a total score between 12 and 60, with higher scores indicating greater self-compassion.
  • Autistic Participant Self Compassion – measured using Self Compassion Scale-Short Form (SCS-SF)
    • Time Frame: 22 Week
    • 12-item measure that assesses the ability to demonstrate care and kindness toward oneself, and acceptance of one’s own imperfections. Self-compassion is often a focus of mindfulness-based interventions because of the interrelatedness with state mindfulness (Nef, 2003). Responses will be given using a 5-point Likert scale that ranged from 1 (“Almost never”) to 5 (“Almost always”), yielding a total score between 12 and 60, with higher scores indicating greater self-compassion.
  • Autistic Community connectedness (ACC) – measured using Autistic Community Connectedness (ACC) measured using Autistic Community Connectedness Measure (ACC)
    • Time Frame: Baseline/enrolment
    • ACC will be used to measure how connected to the autistic community each participant felt. It comprises of ten statements and is rated on a 6-point Likert scale ranging from 1(‘strongly disagree’) to 6, (‘strongly agree’). Total scores range from 10 to 60, with higher scores reflecting greater autistic community connectedness.
  • Autistic Community connectedness (ACC) – measured using Autistic Community Connectedness (ACC) measured using Autistic Community Connectedness Measure (ACC)
    • Time Frame: 7 week
    • ACC will be used to measure how connected to the autistic community each participant felt. It comprises of ten statements and is rated on a 6-point Likert scale ranging from 1(‘strongly disagree’) to 6, (‘strongly agree’). Total scores range from 10 to 60, with higher scores reflecting greater autistic community connectedness.
  • Autistic Community connectedness (ACC) – measured using Autistic Community Connectedness (ACC) measured using Autistic Community Connectedness Measure (ACC)
    • Time Frame: 15 Week
    • ACC will be used to measure how connected to the autistic community each participant felt. It comprises of ten statements and is rated on a 6-point Likert scale ranging from 1(‘strongly disagree’) to 6, (‘strongly agree’). Total scores range from 10 to 60, with higher scores reflecting greater autistic community connectedness.
  • Autistic Community connectedness (ACC) – measured using Autistic Community Connectedness (ACC) measured using Autistic Community Connectedness Measure (ACC)
    • Time Frame: 22 Week
    • ACC will be used to measure how connected to the autistic community each participant felt. It comprises of ten statements and is rated on a 6-point Likert scale ranging from 1(‘strongly disagree’) to 6, (‘strongly agree’). Total scores range from 10 to 60, with higher scores reflecting greater autistic community connectedness.
  • Autistic Participant Satisfaction-measured using Intervention Satisfaction Scale (ISS)
    • Time Frame: Baseline/enrolment
    • At the end of each session of virtual mindfulness session. Participants will be asked open-ended questions asking about what they liked best and least about the group, what the biggest challenges they had to attending group meetings, what would make participation easier, and how they would change the group for future participants via an online survey will be distributed at the end of the course with the post-evaluation measures.
  • Autistic Participant Satisfaction-measured using Intervention Satisfaction Scale (ISS)
    • Time Frame: 7 Week
    • At the end of each session of virtual mindfulness session. Participants will be asked open-ended questions asking about what they liked best and least about the group, what the biggest challenges they had to attending group meetings, what would make participation easier, and how they would change the group for future participants via an online survey will be distributed at the end of the course with the post-evaluation measures.
  • Autistic Participant Satisfaction-measured using Intervention Satisfaction Scale (ISS)
    • Time Frame: 15 Week
    • At the end of each session of virtual mindfulness session. Participants will be asked open-ended questions asking about what they liked best and least about the group, what the biggest challenges they had to attending group meetings, what would make participation easier, and how they would change the group for future participants via an online survey will be distributed at the end of the course with the post-evaluation measures.
  • Autistic Participant Satisfaction-measured using Intervention Satisfaction Scale (ISS)
    • Time Frame: 22 Week
    • At the end of each session of virtual mindfulness session. Participants will be asked open-ended questions asking about what they liked best and least about the group, what the biggest challenges they had to attending group meetings, what would make participation easier, and how they would change the group for future participants via an online survey will be distributed at the end of the course with the post-evaluation measures.
  • Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)
    • Time Frame: Baseline/ enrolment
    • FFMQ-SF will be used to assess five components of mindfulness: observing one’s experiences, describing one’s experiences, acting with awareness, accepting inner experiences in a nonjudgmental way, and accepting inner experiences without reacting. Participants will be asked to rate how generally true each item was for them using a 5-point scale ranging from 1 (“Never or very rarely true”) to 5 (“Very often or always true”), with higher total scores suggesting greater mindfulness (total score range from 24 to 120).
  • Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)
    • Time Frame: 7 Week
    • FFMQ-SF will be used to assess five components of mindfulness: observing one’s experiences, describing one’s experiences, acting with awareness, accepting inner experiences in a nonjudgmental way, and accepting inner experiences without reacting. Participants will be asked to rate how generally true each item was for them using a 5-point scale ranging from 1 (“Never or very rarely true”) to 5 (“Very often or always true”), with higher total scores suggesting greater mindfulness (total score range from 24 to 120).
  • Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)
    • Time Frame: 15 Week
    • FFMQ-SF will be used to assess five components of mindfulness: observing one’s experiences, describing one’s experiences, acting with awareness, accepting inner experiences in a nonjudgmental way, and accepting inner experiences without reacting. Participants will be asked to rate how generally true each item was for them using a 5-point scale ranging from 1 (“Never or very rarely true”) to 5 (“Very often or always true”), with higher total scores suggesting greater mindfulness (total score range from 24 to 120).
  • Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)
    • Time Frame: 22 Week
    • FFMQ-SF will be used to assess five components of mindfulness: observing one’s experiences, describing one’s experiences, acting with awareness, accepting inner experiences in a nonjudgmental way, and accepting inner experiences without reacting. Participants will be asked to rate how generally true each item was for them using a 5-point scale ranging from 1 (“Never or very rarely true”) to 5 (“Very often or always true”), with higher total scores suggesting greater mindfulness (total score range from 24 to 120).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre for Addiction and Mental Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yona Lunsky, Professor – Centre for Addiction and Mental Health

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.