The Virtual Mindfulness Study

NCT05490615 | Unknown

• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Outcome Measures

Primary Outcomes (5)

• Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)

  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).

  Baseline or enrolment (Group-A and Group B)

• Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)

  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).

  7 Weeks (Group-A and Group B)

• Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)

  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).

  15 Weeks (Group-A and Group B)

• Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)

  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).

  22 Weeks (Group-B)

• Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21)

  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).

  30 Weeks (Group-B)

Secondary Outcomes (28)

• 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 Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)

  30 Week (Group B)

Study Arms (2)

Mindfulness Intervention (Group-A)

EXPERIMENTAL

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/)

Behavioral: Virtual Mindfulness

Waitlist Control (Group-B)

NO INTERVENTION

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/)

Interventions

Virtual Mindfulness BEHAVIORAL

Investigators have previously developed and tested a virtual mindfulness program. Six 1-hour weekly group 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. Autistic advisors will participate in sessions as co-facilitators and multiple communication options will be available to group participants (text and audio, camera on or off).

Mindfulness Intervention (Group-A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

CAMH

Toronto, Ontario, M5V 2B4, Canada

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Yona Lunsky, PhD

  CAMH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 5, 2022
• Study Start: November 17, 2022
• Primary Completion: September 15, 2023
• Study Completion: August 30, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CA (1)