App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress

NCT05027113 | Completed

• 1 other identifier: 21-005750
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

In the United States, people of color (POC) are disproportionally affected by stressors related to race/ethnicity compared with their non-Latinx White (NLW). Considering POC exposed to race-related stress are at high risk of developing a mental health disorder, there is a clear need for treatments that allow individuals to cope effectively with these stressors. Among many evidence-based treatments available, mindfulness-based interventions (MBIs) may be particularly well suited to help POC cope. MBIs are hypothesized to be effective via increases in mindfulness and self-compassion, as well as reductions in experiential avoidance, rumination, and emotion suppression. Despite their effectiveness, MBIs rarely reach POC. As such, innovative strategies such as self-directed app-based intervention may reduce the treatment gap. Considering the lack of research examining the effectiveness of MBIs among POC, especially those who experience elevated levels of race-related stress, this study will employ a randomized control trial (RCT) approach to examine whether receiving an app-based MBI engages the hypothesized mechanisms of change (i.e., mindfulness, self-compassion, experiential avoidance, rumination, emotion suppression) among POC. Similarly, the study will test whether the intervention leads to decreases in the negative mental health outcomes more often associated with exposure to race-related stress (i.e., stress, anxiety, depression). Acceptability, adherence, and satisfaction also will be analyzed to explore whether a non-culturally adapted MBI is still relevant for POC who face race-related stress. Results from this trial will contribute to the nascent data on MBI acceptability and effectiveness with POC. To the investigators' knowledge, this study will also be the first to include a sample of POC recruited based on elevated levels of race-related stress, a high-risk population that is not commonly targeted in MBI research.

Conditions

Stress, Psychological; Anxiety; Depression; Rumination; Emotional Regulation; Mindfulness; Self-Compassion; Emotional Distress

Keywords

Race-Related Stress; Mental Health; Mindfulness; Meditation; App

Outcome Measures

Primary Outcomes (3)

• Change in stress

  The 10-item Perceived Stress Scale (PSS) measures stress. Participants rate items on a scale ranging from 0 (Never) to 4 (Very Often) with higher scores indicating more stress. The PSS has shown good reliability (α = .84 - .86) and validity, and it is commonly used in MBI research.

  Through study completion, 1-2 months

• Change in anxiety

  The General Anxiety Disorder (GAD-7) measures anxiety symptoms. Participants rate items on a scale ranging from 0 (Not at all) to 3 (Nearly Every Day) with higher scores indicating more severe anxiety symptoms. The GAD-7 has shown good internal consistency (α = .89 - .90) and validity in POC samples.

  Through study completion, 1-2 months

• Change in depression

  The 8-item Patient Health Questionnaire (PHQ-8) measures depressive symptoms. Participants rate items on a scale ranging from 0 (Not at all) to 3 (Nearly Every Day) with higher scores indicating more severe depressive symptoms.The PHQ-8 omits an item assessing suicidal ideation and self-harm included in the original PHQ-9, which makes it more adequate for self-guided digital intervention research. Furthermore, metanalytic work suggests that the PHQ-8 is practically equivalent to the original measure. The PHQ-8 has good reliability (α = .86 - .89) and has shown validity across different racial/ethnic groups.

  Through study completion, 1-2 months

Secondary Outcomes (5)

• Change in mindfulness

  Through study completion, 1-2 months

• Change in self-Compassion

  Through study completion, 1-2 months

• Change in experiential avoidance

  Through study completion, 1-2 months

• Change in rumination

  Through study completion, 1-2 months

• Change in emotion suppression

  Through study completion, 1-2 months

Other Outcomes (3)

• Change in acceptability and appropriateness of the intervention

  Through study completion, 1-2 months

• Change in treatment adherence

  Through study completion, 1-2 months

• Change in treatment satisfaction

  Through study completion, 1-2 months

Study Arms (2)

Mind-Us

EXPERIMENTAL

Use of the 10% Happier app to complete at least one meditation daily -with the possibility of exceeding this goal by choosing additional meditations- for 4 weeks. Participants will be asked to complete "The Basics" and "The Basics II" courses to familiarize themselves with the principles of mindfulness meditation. Each audio-recorded session begins with a short video providing psychoeducation around mindfulness meditation and teaching specific techniques (e.g., using the breath as an anchor, redirecting attention, noting thoughts and emotions). For the last two weeks of the program, participants will be invited to complete the "Essential Advice" course. This additional course is composed of 14 sessions ranging in length from 15 to 18 minutes.

Behavioral: Mindfulness meditation

Assessments First

NO INTERVENTION

Wait-list control group. Individuals in this group will complete baseline, mid-, and post-treatment assessments before receiving the intervention (i.e., 4 weeks after randomization).

Interventions

Mindfulness meditation BEHAVIORAL

Participants use the meditation app 10% Happier to practice mindfulness meditation (see detailed description in arm/group section)

Also known as: Mind-Us

Mind-Us

Eligibility Criteria

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

You may qualify if:

• Identify as a member of a people of color (POC) group
• Report experiencing elevated levels of race-related stress (i.e., a score of 55 in the IRRS-B or a score of 12 in the MDM)
• Speak and read English,
• Not receive psychological services currently
• Not have practiced mindfulness meditation for more than two hours in the month prior to study commencement
• Own a smartphone with access to the internet
• Be willing to install the MBI app and accept daily notifications and text reminders
• Be at least 18 years old
• Screening Measures:

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

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MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders; Depression; Rumination Syndrome; Emotional Regulation; Psychological Well-Being; Alzheimer Disease

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Self-Control; Social Behavior; Personal Satisfaction; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Giovanni Ramos, MA

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be aware of whether they were randomized to the intervention group or the wait-list control group. The intervention is self-guided and automated through the use of a smartphone app. As such, masking is not an issue. The principal investigator will not be involved with randomization. Assessments are self-administered via online questionnaires. As such, masking is not relevant in terms of outcomes assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Individuals who meet eligibility criteria will be randomized to either the intervention group (n = 40) or a wait-list control group (n = 40),

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 30, 2021
• Study Start: October 13, 2021
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)