Mindfulness for Anxiety During the Coronavirus Pandemic

(SMILE Trial)

Overseen By Kim Faurot, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Cardiac, Seizure, Opioids

Disqualifiers: Heart disease, Stroke, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

404 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking cardiac medications (other than blood pressure medications), seizure medications, or opioids, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Mindfulness for Anxiety During the Coronavirus Pandemic?

Research shows that online-based mindfulness programs can help reduce anxiety, depression, and stress during the COVID-19 pandemic. These programs have been found to be beneficial for both healthcare workers and the general population dealing with psychological issues related to the pandemic. ^{1 2 3 4 5}

Is mindfulness safe for humans?

Mindfulness practices, including Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy, have been studied in various settings and are generally considered safe for humans. These practices have been used to help with stress, anxiety, and depression, especially during the COVID-19 pandemic, without significant safety concerns reported. ^{1 2 3 6 7}

How does the treatment Mindfulness differ from other treatments for anxiety during the COVID-19 pandemic?

Mindfulness is unique because it is a low-cost, non-drug approach that involves practices like meditation to help reduce anxiety and stress. Unlike medications, it can be practiced online and has been shown to improve mental health by decreasing symptoms of depression and anxiety, making it accessible and adaptable for different populations during the pandemic. ^{3 4 8 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the SMILE app, a Digital Health Platform (DHP), that will deliver a mindfulness intervention, designed to mitigate COVID-19 related stress. Additionally, the SMILE app will remotely collect self-reported psychological and physiological metrics of mental health and autonomic regulation. Study participants are adults who self-identify as African American, Black and/or Latino, and who have clinically significant levels of anxiety. The study aims are: * Aim 1: Establish the effectiveness and durability of an 8-week Mindfulness DHP intervention. The investigators will focus on two constructs important to mental health and hypothesize that: A) Anxiety, self-report stress and quality-of-life measures will significantly improve when comparing: A.1) Pre-to-post intervention, and; A.2) Control vs. intervention groups over 8 weeks and at 1-month follow-up. B) Arousal, autonomic indices of HRV (reflecting parasympathetic activation) will significantly improve, when comparing: B.1) Pre-to-post intervention, and; B.2) Control vs. intervention groups over 8 weeks and at 1-month follow-up. * Aim 2: Establish the sustainability of two Mindfulness DHP interventions utilizing retention, usage (frequency), and participant satisfaction. * Aim 3: Examine associations between COVID-19 related stress, mental health outcomes, and HRV. Examine the extent to which COVID-19 related stress and mental health symptoms are linked to HRV at baseline and how that relationship changes over time. Participants will be assigned to 1 of 3 arms of the study: MTIA intervention, MAPP intervention, or wait-list control. All participants will be mailed a device with the SMILE app installed, and the equipment for recording cardiac data in the home. All participants will complete the baseline psychometrics measures and physiological stress test using the instructions provided on the SMILE app. Those assigned to the MTIA or MAPP intervention groups will then participate in their assigned intervention over the subsequent 8 weeks. During these 8 weeks, psychometric and physiological data will be completed biweekly for all participants. 3 months following the initial baseline, all participants will complete a final psychometric/physiological evaluation.

Research Team

Keri J Heilman, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Susan Gaylord, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Maria Davila, PhD

Principal Investigator

Research Triangle Institute (RTI)

Eligibility Criteria

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.

Inclusion Criteria

Self-identify as African American, Black, Hispanic and/or Latino

I have mild to moderate anxiety based on the GAD-7 score.

Exclusion Criteria

Diagnosis of autism

I am on heart medication, not including blood pressure drugs.

I have been diagnosed with a mental health condition like schizophrenia or major depression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete demographic and psychological questionnaires followed by a HRV assessment protocol

1 week

Remote assessment

Intervention

Participants in MTIA and MAPP groups participate in an 8-week mindfulness intervention, with biweekly assessments

8 weeks

Biweekly remote assessments

Follow-up

Participants complete final psychometric and physiological evaluations

4 weeks

Remote assessment at week 12

Treatment Details

Interventions

• Mindfulness

Trial Overview 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.

Participant Groups

Group I: Wait-list Control Active Control 1 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" intervention Active Control 1 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" intervention Active Control 1 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.

Mindfulness is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mindfulness-Based Interventions for:

• Substance Abuse Treatment
• Anxiety Disorders
• Depression

Approved in European Union as Mindfulness-Based Stress Reduction for:

• Stress Management
• Anxiety Disorders
• Chronic Pain

Approved in Canada as Mindfulness-Based Cognitive Therapy for:

• Depression
• Anxiety Disorders
• Substance Abuse Treatment

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

RTI International

Collaborator

Trials

201

Recruited

942,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

Mindfulness-Based Stress Reduction (MBSR) has been shown to improve mental health in 11 studies compared to waitlist controls or treatment as usual, demonstrating its efficacy as a therapeutic intervention.

Mindfulness-Based Cognitive Therapy (MBCT) effectively reduces the risk of depressive relapse, showing similar efficacy to treatment as usual in two studies, indicating its potential as a preventive measure for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Fjorback, LO., Arendt, M., Ornbøl, E., et al.[2022]

A systematic review of six randomized controlled trials (RCTs) found that online-based mindfulness programs can effectively reduce psychological issues like anxiety, depression, and stress during the COVID-19 pandemic.

These mindfulness interventions are suggested as complementary treatments for various groups, including clinical populations, healthy individuals, and healthcare workers facing psychological challenges due to the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological Effects of Online-Based Mindfulness Programs during the COVID-19 Pandemic: A Systematic Review of Randomized Controlled Trials. Yeun, YR., Kim, SD.[2022]

A brief online mindfulness-based intervention (MBI) significantly improved self-care practices among 49 healthcare professionals during the COVID-19 pandemic, indicating its efficacy in helping them cope with stress (p < 0.05).

While personality traits generally did not affect self-care improvements, neuroticism was identified as a key moderating variable, suggesting that individuals with higher levels of neuroticism may benefit differently from mindfulness practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of personality traits on mindful self-care practices of healthcare workers. Osman, I., Singaram, VS.[2023]

In a randomized clinical trial involving 72 caregivers of COVID-19 patients, an Internet-delivered mindfulness stress reduction program combined with acceptance and commitment therapy significantly reduced health anxiety levels compared to a control group.

The intervention also improved the quality of life across various dimensions, including general health perceptions and mental health, indicating that this approach could be beneficial for caregivers in similar stressful situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Internet-delivered Mindfulness Stress Reduction Combined with Acceptance and Commitment Therapy on Health Anxiety and Quality of Life of Caregiver of Patients Infected by COVID-19: A Randomized Clinical Trial. Shahidi, S., Zargar, F., Aghaee Khajelangi, H., et al.[2023]

A brief mindfulness-based stress reduction intervention significantly improved psychological and social quality of life in cardiac patients after a percutaneous coronary intervention (PCI), compared to a self-help control group, with 114 participants involved in the study.

The intervention was particularly effective in reducing anxiety and depression symptoms in patients younger than 60 years, suggesting that mindfulness training may be more beneficial for younger cardiac patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief mindfulness based intervention for increase in emotional well-being and quality of life in percutaneous coronary intervention (PCI) patients: the MindfulHeart randomized controlled trial. Nyklíček, I., Dijksman, SC., Lenders, PJ., et al.[2021]

A randomized controlled trial involving 60 COVID-19 patients demonstrated that an 8-session Mindfulness-Based Stress Reduction (MBSR) program significantly improved mental well-being, with post-intervention scores rising from 56.76 to 80.76 in the intervention group, compared to a decline in the control group.

The study found significant differences in mental well-being dimensions before and after the intervention, suggesting that MBSR can be effectively integrated with physical treatments for better mental health outcomes in COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mindfulness-based Stress Reduction Program in Improving Mental Well-being of Patients with COVID-19: A Randomized Controlled Trial. Sadooghiasl, A., Ghalenow, HR., Mahinfar, K., et al.[2022]

Mindfulness Based Stress Reduction (MBSR) courses delivered online during the COVID-19 pandemic were found to be feasible and acceptable, with course completion rates similar to in-person sessions (84.1% vs 67.6%).

Participants reported significant benefits from the online MBSR, including improved stress coping, quality of life, and morale, suggesting that online formats can effectively expand access to mental health resources during challenging times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction Live Online During the COVID-19 Pandemic: A Mixed Methods Feasibility Study. Riley, TD., Roy, S., Parascando, JA., et al.[2022]

Mindfulness practitioners experienced significantly lower levels of pandemic-related distress, depression, anxiety, and stress compared to non-practitioners during the COVID-19 outbreak, based on assessments from 673 mindfulness practitioners and 1550 non-practitioners.

Increased frequency of mindfulness practice was linked to greater improvements in mental health, suggesting that mindfulness meditation could serve as an effective and low-cost intervention to alleviate psychological distress during pandemics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness practice for protecting mental health during the COVID-19 pandemic. Zhu, JL., Schülke, R., Vatansever, D., et al.[2021]

A brief online mindfulness-based intervention significantly improved mindfulness and reduced psychological distress among 51 Chinese residents during the COVID-19 pandemic, with strong statistical evidence for its effectiveness across various psychological symptoms.

The study demonstrated significant between-group treatment effects, indicating that participants in the mindfulness group experienced greater reductions in anxiety, depression, and somatic symptoms compared to the waitlist control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Online Mindfulness-Based Group Intervention for Psychological Distress Among Chinese Residents During COVID-19: a Pilot Randomized Controlled Trial. Zhang, H., Zhang, A., Liu, C., et al.[2022]

Mindfulness-based stress reduction (MBSR) has been shown to significantly improve anxiety, depression, and pain scores, making it a valuable tool for healthcare professionals and patients during crises like the COVID-19 pandemic.

Long-term meditation practice, including MBSR, is associated with structural and functional changes in the brain, indicating its potential for enhancing mental health across various populations and abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of meditation and mindfulness practices during times of crisis such as COVID-19. Behan, C.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Psychological Effects of Online-Based Mindfulness Programs during the COVID-19 Pandemic: A Systematic Review of Randomized Controlled Trials. [2022]

3. South Africa pubmed.ncbi.nlm.nih.gov

Effects of personality traits on mindful self-care practices of healthcare workers. [2023]

4. Iran pubmed.ncbi.nlm.nih.gov

The Effect of Internet-delivered Mindfulness Stress Reduction Combined with Acceptance and Commitment Therapy on Health Anxiety and Quality of Life of Caregiver of Patients Infected by COVID-19: A Randomized Clinical Trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A brief mindfulness based intervention for increase in emotional well-being and quality of life in percutaneous coronary intervention (PCI) patients: the MindfulHeart randomized controlled trial. [2021]

6. India pubmed.ncbi.nlm.nih.gov

Effectiveness of Mindfulness-based Stress Reduction Program in Improving Mental Well-being of Patients with COVID-19: A Randomized Controlled Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction Live Online During the COVID-19 Pandemic: A Mixed Methods Feasibility Study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Mindfulness practice for protecting mental health during the COVID-19 pandemic. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A Brief Online Mindfulness-Based Group Intervention for Psychological Distress Among Chinese Residents During COVID-19: a Pilot Randomized Controlled Trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The benefits of meditation and mindfulness practices during times of crisis such as COVID-19. [2021]