The Virtual Mindfulness Study

Autism Clinical Trial

Official title:

Virtual Mindfulness for Autistic Adults: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05490615
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: September 2023
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: August 30, 2024
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autism

Intervention

Behavioral:
• Virtual Mindfulness
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).

Locations

Country	Name	City	State
Canada	CAMH	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)	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. 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.	Baseline/enrolment (Group-A and Group B)
Secondary	Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)	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. 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.	7 week (Group-A and Group B)
Secondary	Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)	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. 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.	15 Week (Group-A and Group B)
Secondary	Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)	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. 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.	22 Week (Group B)
Secondary	Autistic Participant Self Compassion - measured using Self Compassion Scale-Short Form (SCS-SF)	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. 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.	30 Week (Group B)
Secondary	Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)	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.	Baseline/enrolment (Group-A and Group B)
Secondary	Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)	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.	7 week (Group-A and Group B)
Secondary	Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)	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.	15 Week (Group-A and Group B)
Secondary	Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)	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.	22 Week (Group B)
Secondary	Autistic Community connectedness (ACC) - measured using Autistic Community Connectedness Measure (ACC)	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.	30 Week (Group B)
Secondary	Autistic Participant Satisfaction-measured using Intervention Satisfaction Scale (ISS)	At the end 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. Participants will be asked to rate some items, 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 0 to 100)	7 Week (Group-A)
Secondary	Autistic Participant Satisfaction-measured using Intervention Satisfaction Scale (ISS)	At the end 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.; Participants will be asked to rate some items, 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 0 to 100).	22 Week (Group B)
Secondary	Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)	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).	Baseline/ enrolment (Group-A and Group B)
Secondary	Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)	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).	7 Week (Group-A and Group B)
Secondary	Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)	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).	15 Week (Group-A and Group B)
Secondary	Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)	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).	22 Week (Group B)
Secondary	Autistic Participant reactivity, observing, acting aware, describing, and non-judgment- measured using Five-Facet Mindfulness Questionnaire- Short Form (FFMQ-SF)	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).	30 Week (Group B)
Secondary	Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)	ISQ-8 will be used to measure interoception, the ISQ-8 is the first psychometrically validated self-report measure of interoception for autistic adolescents and adults,and is adapted from the ISQ-20. Items are rated on a 5-point likert scale. A higher score indicates more difficulty registering or interpreting interoceptive sensations.	Baseline (Group-A and Group B)
Secondary	Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)	ISQ-8 will be used to measure interoception, the ISQ-8 is the first psychometrically validated self-report measure of interoception for autistic adolescents and adults,and is adapted from the ISQ-20. Items are rated on a 5-point likert scale. A higher score indicates more difficulty registering or interpreting interoceptive sensations.	7 Week (Group-A and Group B)
Secondary	Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)	ISQ-8 will be used to measure interoception, the ISQ-8 is the first psychometrically validated self-report measure of interoception for autistic adolescents and adults,and is adapted from the ISQ-20. Items are rated on a 5-point likert scale. A higher score indicates more difficulty registering or interpreting interoceptive sensations.	15 Week (Group-A and Group B)
Secondary	Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)	ISQ-8 will be used to measure interoception, the ISQ-8 is the first psychometrically validated self-report measure of interoception for autistic adolescents and adults,and is adapted from the ISQ-20. Items are rated on a 5-point likert scale. A higher score indicates more difficulty registering or interpreting interoceptive sensations.	22 Week (Group B)
Secondary	Autistic Participant Interoception measured using, Interoception Sensory Questionnaire (ISQ-8)	ISQ-8 will be used to measure interoception, the ISQ-8 is the first psychometrically validated self-report measure of interoception for autistic adolescents and adults,and is adapted from the ISQ-20. Items are rated on a 5-point likert scale. A higher score indicates more difficulty registering or interpreting interoceptive sensations.	30 Week (Group B)
Secondary	Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS	The Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS is a 7-item measure of psychological wellbeing. Example items include 'I've been feeling relaxed' and 'I've been interested in new things'. Participants rated items on a 5-point Likert scale ['none of the time' (1) to 'all of the time' (5)]. Scores could range from 14 to 70, and higher scores indicated more positive mental wellbeing.	Baseline (Group-A and Group B)
Secondary	Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS	The Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS is a 7-item measure of psychological wellbeing. Example items include 'I've been feeling relaxed' and 'I've been interested in new things'. Participants rated items on a 5-point Likert scale ['none of the time' (1) to 'all of the time' (5)]. Scores could range from 14 to 70, and higher scores indicated more positive mental wellbeing.	7 Week (Group-A and Group B)
Secondary	Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS	The Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS is a 7-item measure of psychological wellbeing. Example items include 'I've been feeling relaxed' and 'I've been interested in new things'. Participants rated items on a 5-point Likert scale ['none of the time' (1) to 'all of the time' (5)]. Scores could range from 14 to 70, and higher scores indicated more positive mental wellbeing.	15 Week (Group-A and Group B)
Secondary	Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS	The Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS is a 7-item measure of psychological wellbeing. Example items include 'I've been feeling relaxed' and 'I've been interested in new things'. Participants rated items on a 5-point Likert scale ['none of the time' (1) to 'all of the time' (5)]. Scores could range from 14 to 70, and higher scores indicated more positive mental wellbeing.	22 Week (Group B)
Secondary	Autistic participant mental well-being measured using, the Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS	The Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWS is a 7-item measure of psychological wellbeing. Example items include 'I've been feeling relaxed' and 'I've been interested in new things'. Participants rated items on a 5-point Likert scale ['none of the time' (1) to 'all of the time' (5)]. Scores could range from 14 to 70, and higher scores indicated more positive mental wellbeing.	30 Week (Group B)
Secondary	Follow-up Satisfaction Form	At the end of the study participants will be asked 8 likert scale close ended questions and 10 open ended questions about what they liked best about the research study what were the biggest challenges they had, what would make participation easier, and what they would change for future participants via online survey at the end of the study.	End of the Study