AnxietySMARTNCT05880498
Smartphone Mindfulness Autism Research Study
A study testing Mindfulness Intervention in people with Anxiety and Stress, run by Massachusetts Institute of Technology at 1 site in United States.
Trial summary
Individuals diagnosed with autism are also often diagnosed with anxiety disorders. Therefore, having useful strategies to manage stress and anxiety may be particularly helpful for autistic individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2022to 17 Apr 2023
- 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
- Daily access to smartphone
- Professional diagnosis of autism spectrum disorder
Who cannot join
- Non-corrected hearing impairment (if it impacts their ability to listen to the app)
- Far below average nonverbal intellectual ability: 2 standard deviations below the mean on the Test My Brain, matrix reasoning subtest (a validated and normed proxy for nonverbal IQ)
- Listening comprehension skills that may compromise one's ability to understand the lessons and practices in the app: Below 60% correct on the Listening Comprehension measure (created for this study, based on language used in the Healthy Minds app)
- Ever taken part in a meditation retreat
- Engaged in meditation practice at least once per week over the past year
- Used Healthy Minds app ever
- Prior training with a meditation teacher (other than an introductory course)
- Practiced meditation daily for the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
About this study
Official title: Smartphone Mindfulness Autism Research Team Study
Individuals diagnosed with autism are also often diagnosed with anxiety disorders. Therefore, having useful strategies to manage stress and anxiety may be particularly helpful for autistic individuals. Mindfulness-based interventions, delivered in-person as well as those offered remotely online, have been found to lower stress and anxiety. Although in-person mindfulness training has been found to be helpful for autistic individuals, there is little research that has studied remote app-based mindfulness training in autistic adults.
This study examines whether a six-week structured intervention, using a mindfulness app, lowers anxiety and stress in autistic adults. Participants were randomly assigned either to an intervention group, which started the intervention immediately, or a wait-list control group, which participated in the same intervention program six-weeks later. Findings will provide important information about the potential for remote app-based mindfulness training to lower stress and anxiety in adults diagnosed with autism.
Read the detailed description
A significant proportion of individuals diagnosed with autism are also diagnosed with one or more anxiety disorders. Since stress and anxiety in autism have been found to exacerbate common symptoms associated with autism, such as sleep problems and sensory sensitivities, having effective strategies to manage anxiety and stress may be particularly beneficial for autistic individuals. Mindfulness-based therapies have been increasingly recognized as promising interventions to reduce stress and anxiety, and improve mental health in individuals with and without autism. Several studies of individuals without autism have demonstrated that remote digital mindfulness training is equally as effective as traditional in-person mindfulness training in reducing stress and anxiety and enhancing well-being. However, there is little research investigating remote app-based mindfulness training for autistic individuals, which could be especially beneficial with this population due to anxiety and other constraints that make in-person training less feasible.
The primary objective is to assess efficacy of a six-week remote self-guided mindfulness intervention in reducing anxiety and stress in autistic adults. Autistic adults were invited to participate in a remote app-based mindfulness study where participants use their smartphones to complete the six-week structured mindfulness intervention. Participants were block randomized (based on initial trait anxiety scores) to either an intervention group or a wait-list control group. The intervention group immediately received the online mindfulness intervention. The wait-list control group received the same intervention program six-weeks later. All sessions and assessments were delivered online; thus participants were allowed maximal flexibility in participating in this fully remote intervention.
Self-reported levels of stress, anxiety, positive and negative emotions, and trait/dispositional mindfulness were measured at four time-points throughout the study: before the intervention, half-way through (at 3 weeks), after the intervention, and at follow-up (6 weeks after the end of the intervention). The wait-list control group was assessed at two additional time-points: before they began their waiting period and half-way through their waiting period (at 3 weeks). The primary aim of the study is to compare between-group (and secondarily, within-group) outcome measures to determine whether stress and anxiety levels decrease after the mindfulness intervention and whether they decrease above and beyond any decreases experienced by the wait-list control group.
Additionally, the study aims to:
- Determine whether and how changes in mindfulness are associated with changes in anxiety and stress, over the course of the intervention, including whether there is a negative association of mindfulness with stress and anxiety. In using two different measures of mindfulness the specific components of mindfulness can be examined that appear to be most likely to change and most likely to be (negatively) associated with stress and anxiety.
- Assess the feasibility of such a remote intervention with this sample of autistic adults by examining:
- percentages of individuals in each group (intervention and wait-list control) who complete various stages of the intervention (e.g., post-test surveys, follow-up surveys).
- percentages of individuals in each group (intervention and wait-list control) who complete all of the intervention activities, as well as those who complete at least a certain percentage (e.g. 50% and 75%) of the intervention activities.
- Examine who seems to benefit most from the intervention (by demographic variables, autistic traits, and other baseline measures obtained).
The aim is to have approximately 30 participants per group participate in the intervention and complete follow-up surveys. Individuals initially completed screening questionnaires to determine study eligibility. Eligible individuals were then given baseline measures, which included the outcome measures as well as autistic characterization measures. Participants were then randomly assigned (through block randomization based on baseline trait anxiety scores) to either the intervention group or the wait-list control group.
After completing their pre-intervention surveys participants were instructed to download the Healthy Minds customized application for this study and were then given a start date for the six-week self-guided intervention. They received automated emails instructing them to complete the outcome measures at the time-points specified above.
The intervention consisted of a customized version of the Healthy Minds app, with six-weeks of alternating didactic 'lessons' (each up to 7 minutes in length) and mindfulness 'practices' (either 10 minutes or 15 minutes in length- as chosen by the participant). There were a total of 29 lessons and practices that were part of the structured curriculum. Other optional practices were included on the app as well. Participants were instructed to listen to (at least) one activity per day for 5 days per week, for 6 weeks. They were told that it was suggested (but not required) that they listen to the activities in order, that they could re-listen to activities as they desired, and that they could listen to the optional practices as they saw fit.
Findings from this intervention will provide important information about the feasibility of remote app-based mindfulness training for autistic adults and the potential of remote app-based mindfulness training to reduce stress and anxiety in this population.
- Being tested
- Mindfulness Intervention
- Keywords
- Autism, Mindfulness
- Medical subject headings
- Anxiety Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness InterventionBehavioural
Self-guided mindfulness training using a customized version of the Healthy Minds app
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention | Experimental | 6 week smartphone-based self-guided mindfulness training using a customized version of the Healthy Minds app.
Participants were instructed to listen to at least one activity per day for 5 days per week, for 6 weeks. Activities that were part of the structured curriculum consisted of alternating mindfulness didactic 'lessons' (each up to 7 minutes in length) and mindfulness 'practices' (either 10 minutes or 15 minutes in length- as chosen by the participant). Receives: Behavioral: Mindfulness Intervention |
| Wait-List Control (WLC) | No intervention | No intervention was administered during the 6-week wait list control period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory for Adults
40-item self-report assessing both state anxiety (20 items) and trait anxiety (20 items) on a 4-point Likert scale. Total trait anxiety scores range from 20 to 80. Total state anxiety scores range from 20 to 80. Higher scores are indicative of a greater level of anxiety.
Measured: 6 Weeks
Patient-Reported Outcomes Measurement Information System [PROMIS] Anxiety Short Form
8-item self-report measure of anxiety, on a 5-point Likert scale. Raw scores range from 8 to 40, with higher scores indicating more anxiety.
Measured: 6 weeks
Secondary outcomes (6)
State-Trait Anxiety Inventory for Adults
40-item self-report assessing both state anxiety (20 items) and trait anxiety (20 items) on a 4-point Likert scale. Total trait anxiety scores range from 20 to 80. Total state anxiety scores range from 20 to 80. Higher scores are indicative of a greater level of anxiety.
Measured: 12 Weeks
Patient-Reported Outcomes Measurement Information System [PROMIS] Anxiety Short Form
8-item self-report measure of anxiety, on a 5-point Likert scale. Raw scores range from 8 to 40, with higher scores indicating more anxiety.
Measured: 12 weeks
Perceived Stress Scale
10-item self-report measure of stress, on a 5-point Likert scale. Scores range from 0 to 40. Higher scores signify more stress.
Measured: 6 weeks
Perceived Stress Scale
10-item self-report measure of stress, on a 5-point Likert scale. Scores range from 0 to 40. Higher scores signify more stress.
Measured: 12 weeks
Positive and Negative Affect Schedule, Short Form
20-item self-report of 10 positive and 10 negative emotions, on a 5-point Likert scale, resulting in both a positive and a negative affect score. Scores for each scale range from 10-50, with higher scores on the Positive Affect Score indicating a greater degree of positive emotions, and higher scores on the Negative Affect Score indicating a greater degree of negative emotions.
Measured: 6 weeks
Positive and Negative Affect Schedule, Short Form
20-item self-report of 10 positive and 10 negative emotions, on a 5-point Likert scale, resulting in both a positive and a negative affect score. Scores for each scale range from 10-50, with higher scores on the Positive Affect Score indicating a greater degree of positive emotions, and higher scores on the Negative Affect Score indicating a greater degree of negative emotions.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start30 Jan 2022
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John DE Gabrieli, PhD, Principal investigator, Massachusetts Institute of TechnologyLiron Rozenkrantz, PhD, Study director, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880498
- Sponsor's protocol ID
- 2105000376
- Acronym
- SMART
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to results in a publication will be available upon request to approved researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Mindfulness Autism Research Team Study
- ClinicalTrials.gov ID
- NCT05880498
- Acronym / sponsor ID
- SMART / 2105000376
- Keywords
- Autism, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals diagnosed with autism are also often diagnosed with anxiety disorders. Therefore, having useful strategies to manage stress and anxiety may be particularly helpful for autistic individuals. Mindfulness-based interventions, delivered in-person as well as those offered remotely online, have been found to lower stress and anxiety. Although in-person mindfulness training has been found to be helpful for autistic individuals, there is little research that has studied remote app-based mindfulness training in autistic adults.
This study examines whether a six-week structured intervention, using a mindfulness app, lowers anxiety and stress in autistic adults. Participants were randomly assigned either to an intervention group, which started the intervention immediately, or a wait-list control group, which participated in the same intervention program six-weeks later. Findings will provide important information about the potential for remote app-based mindfulness training to lower stress and anxiety in adults diagnosed with autism.
Detailed description
A significant proportion of individuals diagnosed with autism are also diagnosed with one or more anxiety disorders. Since stress and anxiety in autism have been found to exacerbate common symptoms associated with autism, such as sleep problems and sensory sensitivities, having effective strategies to manage anxiety and stress may be particularly beneficial for autistic individuals. Mindfulness-based therapies have been increasingly recognized as promising interventions to reduce stress and anxiety, and improve mental health in individuals with and without autism. Several studies of individuals without autism have demonstrated that remote digital mindfulness training is equally as effective as traditional in-person mindfulness training in reducing stress and anxiety and enhancing well-being. However, there is little research investigating remote app-based mindfulness training for autistic individuals, which could be especially beneficial with this population due to anxiety and other constraints that make in-person training less feasible.
The primary objective is to assess efficacy of a six-week remote self-guided mindfulness intervention in reducing anxiety and stress in autistic adults. Autistic adults were invited to participate in a remote app-based mindfulness study where participants use their smartphones to complete the six-week structured mindfulness intervention. Participants were block randomized (based on initial trait anxiety scores) to either an intervention group or a wait-list control group. The intervention group immediately received the online mindfulness intervention. The wait-list control group received the same intervention program six-weeks later. All sessions and assessments were delivered online; thus participants were allowed maximal flexibility in participating in this fully remote intervention.
Self-reported levels of stress, anxiety, positive and negative emotions, and trait/dispositional mindfulness were measured at four time-points throughout the study: before the intervention, half-way through (at 3 weeks), after the intervention, and at follow-up (6 weeks after the end of the intervention). The wait-list control group was assessed at two additional time-points: before they began their waiting period and half-way through their waiting period (at 3 weeks). The primary aim of the study is to compare between-group (and secondarily, within-group) outcome measures to determine whether stress and anxiety levels decrease after the mindfulness intervention and whether they decrease above and beyond any decreases experienced by the wait-list control group.
Additionally, the study aims to:
- Determine whether and how changes in mindfulness are associated with changes in anxiety and stress, over the course of the intervention, including whether there is a negative association of mindfulness with stress and anxiety. In using two different measures of mindfulness the specific components of mindfulness can be examined that appear to be most likely to change and most likely to be (negatively) associated with stress and anxiety.
- Assess the feasibility of such a remote intervention with this sample of autistic adults by examining:
- percentages of individuals in each group (intervention and wait-list control) who complete various stages of the intervention (e.g., post-test surveys, follow-up surveys).
- percentages of individuals in each group (intervention and wait-list control) who complete all of the intervention activities, as well as those who complete at least a certain percentage (e.g. 50% and 75%) of the intervention activities.
- Examine who seems to benefit most from the intervention (by demographic variables, autistic traits, and other baseline measures obtained).
The aim is to have approximately 30 participants per group participate in the intervention and complete follow-up surveys. Individuals initially completed screening questionnaires to determine study eligibility. Eligible individuals were then given baseline measures, which included the outcome measures as well as autistic characterization measures. Participants were then randomly assigned (through block randomization based on baseline trait anxiety scores) to either the intervention group or the wait-list control group.
After completing their pre-intervention surveys participants were instructed to download the Healthy Minds customized application for this study and were then given a start date for the six-week self-guided intervention. They received automated emails instructing them to complete the outcome measures at the time-points specified above.
The intervention consisted of a customized version of the Healthy Minds app, with six-weeks of alternating didactic 'lessons' (each up to 7 minutes in length) and mindfulness 'practices' (either 10 minutes or 15 minutes in length- as chosen by the participant). There were a total of 29 lessons and practices that were part of the structured curriculum. Other optional practices were included on the app as well. Participants were instructed to listen to (at least) one activity per day for 5 days per week, for 6 weeks. They were told that it was suggested (but not required) that they listen to the activities in order, that they could re-listen to activities as they desired, and that they could listen to the optional practices as they saw fit.
Findings from this intervention will provide important information about the feasibility of remote app-based mindfulness training for autistic adults and the potential of remote app-based mindfulness training to reduce stress and anxiety in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention | Experimental | Behavioral: Mindfulness Intervention6 week smartphone-based self-guided mindfulness training using a customized version of the Healthy Minds app. Participants were instructed to listen to at least one activity per day for 5 days per week, for 6 weeks. Activities that were part of the structured curriculum consisted of alternating mindfulness didactic 'lessons' (each up to 7 minutes in length) and mindfulness 'practices' (either 10 minutes or 15 minutes in length- as chosen by the participant). |
| Wait-List Control (WLC) | No intervention | –No intervention was administered during the 6-week wait list control period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Daily access to smartphone
- Professional diagnosis of autism spectrum disorder
Key exclusion criteria (8 listed)
- Non-corrected hearing impairment (if it impacts their ability to listen to the app)
- Far below average nonverbal intellectual ability: 2 standard deviations below the mean on the Test My Brain, matrix reasoning subtest (a validated and normed proxy for nonverbal IQ)
- Listening comprehension skills that may compromise one's ability to understand the lessons and practices in the app: Below 60% correct on the Listening Comprehension measure (created for this study, based on language used in the Healthy Minds app)
- Ever taken part in a meditation retreat
- Engaged in meditation practice at least once per week over the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness InterventionSelf-guided mindfulness training using a customized version of the Healthy Minds app | Behavioural | Mindfulness Intervention |
Primary outcome
State-Trait Anxiety Inventory for Adults
Time frame: 6 Weeks
40-item self-report assessing both state anxiety (20 items) and trait anxiety (20 items) on a 4-point Likert scale. Total trait anxiety scores range from 20 to 80. Total state anxiety scores range from 20 to 80. Higher scores are indicative of a greater level of anxiety.
Patient-Reported Outcomes Measurement Information System [PROMIS] Anxiety Short Form
Time frame: 6 weeks
8-item self-report measure of anxiety, on a 5-point Likert scale. Raw scores range from 8 to 40, with higher scores indicating more anxiety.
6 secondary outcomes
State-Trait Anxiety Inventory for Adults
Time frame: 12 Weeks
Patient-Reported Outcomes Measurement Information System [PROMIS] Anxiety Short Form
Time frame: 12 weeks
Perceived Stress Scale
Time frame: 6 weeks
Perceived Stress Scale
Time frame: 12 weeks
Positive and Negative Affect Schedule, Short Form
Time frame: 6 weeks
Positive and Negative Affect Schedule, Short Form
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to results in a publication will be available upon request to approved researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John DE Gabrieli, PhD principal investigator
Massachusetts Institute of Technology
Liron Rozenkrantz, PhD study director
Massachusetts Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Intervention in people with Anxiety and Stress, run by Massachusetts Institute of Technology at 1 site in United States.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 30 May 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
State-Trait Anxiety Inventory for Adults (time frame: 6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2023.