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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

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 more

SMILE Trial Design

3Treatment groups

Active Control

Group I: "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 II: 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 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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

RTI InternationalOTHER

190 Previous Clinical Trials

875,943 Total Patients Enrolled

1 Trials studying Anxiety

105 Patients Enrolled for Anxiety

University of North Carolina, Chapel HillLead Sponsor

1,513 Previous Clinical Trials

4,193,776 Total Patients Enrolled

12 Trials studying Anxiety

3,803 Patients Enrolled for Anxiety

National Institute on Minority Health and Health Disparities (NIMHD)NIH

388 Previous Clinical Trials

1,217,801 Total Patients Enrolled

6 Trials studying Anxiety

1,311 Patients Enrolled for Anxiety

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I be considered a suitable candidate to partake in this clinical study?

"Candidates with anxiety aged 18 to 99 are sought for this study. The trial aims to recruit approximately 404 participants."

Answered by AI

What is the primary aim of conducting this clinical investigation?

"The primary aim of this clinical investigation, to be evaluated from Baseline through 8 weeks, is the alteration observed in the Generalized Anxiety Disorder-7 scale between Baseline and Follow-up. Secondary objectives encompass changes in autonomic function as determined by heart period using the Polar H10 device with a range of 200-1500 msec; variations in parasympathetic activity assessed via high-frequency heart rate variability (HF-HRV) calculated through CardioBatch Plus software within a range of 0 - 15 ln(msec), where higher values denote increased parasympathetic activation both post-intervention and at follow-up."

Answered by AI

Are individuals over the age of 30 being sought for enrollment in this research study?

"Individuals between the ages of 18 and 99 are eligible for participation in this trial as per the inclusion criteria. For those under 18 years old, there are a total of 184 trials available, while individuals over the age of 65 have access to 750 trials."

Answered by AI

Is the enrollment process currently in progress for participants of this research study?

"The information provided on clinicaltrials.gov indicates that this particular medical trial is not presently seeking participants. Despite being first listed on March 1st, 2024 and last revised on February 1st of the same year, it is important to note that there are currently 951 other ongoing studies actively enrolling subjects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SMILE: Clinical Trial to Evaluate Mindfulness as Intervention for Racial and Ethnic Populations During COVID-19

2024. "SMILE: Clinical Trial to Evaluate Mindfulness as Intervention for Racial and Ethnic Populations During COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06242080.

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