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Behavioural Intervention
"MTIA" intervention for Anxiety (SMILE Trial)
N/A
Recruiting
Led By Susan Gaylord, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Demonstrate symptoms of anxiety, as determined based on the GAD-7 screening measure (score between 8-14)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
SMILE Trial Summary
This trial aims to assess the effectiveness of a mindfulness intervention delivered through a smartphone app called SMILE in reducing stress related to COVID-19. The study will include adults who identify as African American, Black
Who is the study for?
The SMILE clinical trial is for African American, Black and/or Latino adults experiencing significant anxiety due to COVID-19. Participants must be willing to use the SMILE app and a device that records cardiac data at home. The study excludes details on specific exclusion criteria.Check my eligibility
What is being tested?
This trial tests an 8-week mindfulness program delivered through the SMILE app, aiming to reduce stress related to COVID-19. It measures improvements in anxiety, stress levels, quality of life, and heart rate variability (HRV). Participants are randomly placed into two intervention groups or a wait-list control group.See study design
What are the potential side effects?
Since this trial involves a non-invasive mindfulness intervention via an app, there are no direct physical side effects expected from participation. However, emotional discomfort may arise when engaging with mental health content.
SMILE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have mild to moderate anxiety based on the GAD-7 score.
SMILE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline to Follow-up in the Generalized Anxiety Disorder-7 scale
Change from Baseline to Post-Intervention in the Generalized Anxiety Disorder-7 scale
Secondary outcome measures
Change in Autonomic activity from Baseline to Follow-up as measured by heart period
Change in Autonomic activity from Baseline to Post-Intervention as measured by heart period
Change in Parasympathetic activity Baseline to Follow-up as measured by high-frequency heart rate variability (HF-HRV)
+31 moreSMILE Trial Design
3Treatment groups
Active Control
Group I: Wait-list ControlActive Control1 Intervention
The Wait-list Control (WLC) group will participate in all research assessment sessions, but will not be offered the Mindfulness intervention until after their role in the research is complete.
Group II: "MTIA" interventionActive Control1 Intervention
The Mindfulness Training Instructor Administered ("MTIA") intervention will incorporate the following elements: training in an 8-week, 90-minute per week, modified mindfulness program, which places additional emphasis on training which is feasible and relevant to race/ethnic groups, including: a) didactics on relevance to stress, coping and resilience, b) mindful compassion for self and others; c) mindful communication, including non-verbal mindfulness, mindful listening, and mindful speaking. The MTIA will be instructor led, internet-delivered (via Zoom), interactive, group-based mindfulness training intervention that will incorporate the training for approximately 9 persons in a group format, with outside-of session assignments.
Group III: "MAPP" interventionActive Control1 Intervention
The MindfulnessAPP ("MAPP") is a self-administered intervention developed by the SMILE study team. The MAPP is for individual use, with eight MAPP sessions composed of mindfulness exercises and didactics that correspond to the MTIA sessions. As the MTIA weekly class will be 90 minutes in length, the MAPP assignments will recommend spending approximately 90 minutes per week covering the assigned lesson, but in a flexible format convenient for the participant. In addition, each session will contain mindfulness-based practice assignments generally ranging from 10 to 30 minutes per day. The total number of suggested days for completion will be 49 days, comparable to the time from start to finish of a traditional 8 week MTIA session; however, there will be flexibility within this individualized program.
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Who is running the clinical trial?
RTI InternationalOTHER
190 Previous Clinical Trials
810,299 Total Patients Enrolled
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University of North Carolina, Chapel HillLead Sponsor
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National Institute on Minority Health and Health Disparities (NIMHD)NIH
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1,811 Patients Enrolled for Anxiety
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