Smartphone Mindfulness Autism Research Study

NCT05880498 | Completed

• 1 other identifier: 2105000376
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anxiety; Stress

Keywords

Autism; Mindfulness

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 weeks

Secondary Outcomes (6)

• State-Trait Anxiety Inventory for Adults

  12 Weeks

• Patient-Reported Outcomes Measurement Information System [PROMIS] Anxiety Short Form

  12 weeks

• Perceived Stress Scale

  6 weeks

• Perceived Stress Scale

  12 weeks

• Positive and Negative Affect Schedule, Short Form

  6 weeks

Other Outcomes (10)

• Mindfulness Attention Awareness Scale

  3 weeks

• Mindfulness Attention Awareness Scale

  6 weeks

• Mindfulness Attention Awareness Scale

  12 weeks

Study Arms (2)

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).

Behavioral: Mindfulness Intervention

Wait-List Control (WLC)

NO INTERVENTION

No intervention was administered during the 6-week wait list control period.

Interventions

Mindfulness Intervention BEHAVIORAL

Self-guided mindfulness training using a customized version of the Healthy Minds app

Mindfulness Intervention

Eligibility Criteria

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

You may qualify if:

• Daily access to smartphone
• Professional diagnosis of autism spectrum disorder

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Institute of Technology: lead

Study Sites (1)

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Autistic Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

• John DE Gabrieli, PhD

  Massachusetts Institute of Technology

  PRINCIPAL INVESTIGATOR

• Liron Rozenkrantz, PhD

  Massachusetts Institute of Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 30, 2023
• Study Start: January 30, 2022
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified data will be available upon request starting 6 months after publication and will remain available for 3 years.
• Access Criteria: Data requests should be submitted to Cindy Li at cindyeli@mit.edu including a description of study aims as well as how the data will be utilized. Requests will be reviewed by the team and secure access to the requested data will be provided in the form of downloadable materials.

Locations

US (1)