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AutismNCT05490615

The Virtual Mindfulness Study

A study testing Virtual Mindfulness in people with Autism, run by Centre for Addiction and Mental Health at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Autism
What is being tested?
Virtual Mindfulness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteCanada
Study dates
17 Nov 2022to 30 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • CAMH

    Toronto, Ontario, M5V 2B4

Other trials in Canada

About this study

Official title: Virtual Mindfulness for Autistic Adults: A Randomized Controlled Trial

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.

Read the 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.

Conditions
Autism
Being tested
Virtual Mindfulness
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual MindfulnessBehavioural

    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).

Study groups in NCT05490615
Study groupRoleWhat they receive
Mindfulness Intervention (Group-A)ExperimentalTotal 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/)
Receives: Behavioral: Virtual Mindfulness
Waitlist Control (Group-B)No interventionTotal 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/)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline or enrolment (Group-A and Group B)

  2. 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).

    Measured: 7 Weeks (Group-A and Group B)

  3. 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).

    Measured: 15 Weeks (Group-A and Group B)

  4. 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).

    Measured: 22 Weeks (Group-B)

  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 suscale multiplied by 2).

    Measured: 30 Weeks (Group-B)

Secondary outcomes (28)
  1. 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.

    Measured: Baseline/enrolment (Group-A and Group B)

  2. 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.

    Measured: 7 week (Group-A and Group B)

  3. 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.

    Measured: 15 Week (Group-A and Group B)

  4. 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.

    Measured: 22 Week (Group B)

  5. 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.

    Measured: 30 Week (Group B)

  6. 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.

    Measured: Baseline/enrolment (Group-A and Group B)

  7. 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.

    Measured: 7 week (Group-A and Group B)

  8. 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.

    Measured: 15 Week (Group-A and Group B)

  9. 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.

    Measured: 22 Week (Group B)

  10. 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.

    Measured: 30 Week (Group B)

  11. 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)

    Measured: 7 Week (Group-A)

  12. 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).

    Measured: 22 Week (Group B)

  13. 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).

    Measured: Baseline/ enrolment (Group-A and Group B)

  14. 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).

    Measured: 7 Week (Group-A and Group B)

  15. 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).

    Measured: 15 Week (Group-A and Group B)

  16. 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).

    Measured: 22 Week (Group B)

  17. 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).

    Measured: 30 Week (Group B)

  18. 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.

    Measured: Baseline (Group-A and Group B)

  19. 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.

    Measured: 7 Week (Group-A and Group B)

  20. 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.

    Measured: 15 Week (Group-A and Group B)

  21. 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.

    Measured: 22 Week (Group B)

  22. 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.

    Measured: 30 Week (Group B)

  23. 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.

    Measured: Baseline (Group-A and Group B)

  24. 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.

    Measured: 7 Week (Group-A and Group B)

  25. 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.

    Measured: 15 Week (Group-A and Group B)

  26. 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.

    Measured: 22 Week (Group B)

  27. 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.

    Measured: 30 Week (Group B)

  28. 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.

    Measured: End of the Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start17 Nov 2022
  3. Primary completion15 Sep 2023
  4. Study completion30 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05490615
Status last verified
Sep 2023
First submitted
4 Aug 2022
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lunsky Y, Carter M, Hutton S, Wozniak J, Chen S, Weiss J. Virtual group-based mindfulness for autistic adults: A randomized controlled trial. Autism. 2025 Oct;29(10):2489-2500. doi: 10.1177/13623613251340101. Epub 2025 Jul 1.

    PubMed 40598750

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Mindfulness in people with Autism, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychological distress: measured using the Depression and Anxiety Stress Scale (DASS-21) (time frame: Baseline or enrolment (Group-A and Group B)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05490615, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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