Depression Clinical Trial
Official title:
App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress: A Randomized Control Trial
Verified date | May 2023 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 155 |
Est. completion date | December 2, 2022 |
Est. primary completion date | December 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Individuals interested in participating in this study will complete an online screening questionnaire using Qualtrics, a platform that is smartphone compatible. For study inclusion, participants are required to: 1. Identify as a member of a people of color (POC) group 2. 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) 3. Speak and read English, 4. Not receive psychological services currently 5. Not have practiced mindfulness meditation for more than two hours in the month prior to study commencement 6. Own a smartphone with access to the internet 7. Be willing to install the MBI app and accept daily notifications and text reminders 8. Be at least 18 years old Screening Measures: Race-Related Stress. The 22-item Index of Race-Related Stress-Brief (IRRS-B) measures multiple sources of race-related stress, including Individual, Institutional, and Cultural. Participants rate items on a scale ranging from 0 (This Never Happened to Me) to 4 (This Event Happened and I was Extremely Upset), with higher scores indicating more race-related stress. The IRRS-B was developed with a POC sample (i.e., Blacks), showing adequate reliability (a = .78) for both Cultural and Individual subscales and acceptable reliability (a = .69) for the Institutional subscale. For study inclusion, participants need to obtain a score of 55, which represents elevated race-related stress. Perceived Discrimination. The 8-item Multicultural Discrimination Module (MDM) measures perceived discrimination. Participants rate items on a scale ranging from 1 (Never) to 4 (Often) with higher scores indicating more levels of perceived discrimination. The MDM was developed using a U.S. population-based sample (approximately 40% POC) and has shown good internal consistency (a = .81 - .88) in a previous study. For study inclusion, participants need to obtain a score of 12, which represents the 75th percentile of the population distribution. Exclusion Criteria: - NA |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
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University of California, Los Angeles |
United States,
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* Note: There are 111 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in acceptability and appropriateness of the intervention | The 16-item Attitudes towards Psychological Online Interventions (APOI) measures experiences with digital interventions. Participants rate items on a scale ranging from 1 (Totally Agree) to 5 (Totally Disagree) with higher scores indicating more perceived acceptability and appropriateness. The APOI has shown good reliability (a = .83) and validity in previous studies. | Through study completion, 1-2 months | |
Other | Change in treatment adherence | Number of meditations completed, total time meditated in minutes, and number of days with at least one meditation with will be used as behavioral measures of treatment adherence. This information is tracked by the app. | Through study completion, 1-2 months | |
Other | Change in treatment satisfaction | The 7-item Satisfaction with Therapy (ST) subscale of the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) measures treatment satisfaction. Participants rate items on a scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree) with higher scores showing more treatment satisfaction. The ST subscale has shown excellent reliability (a = .92) and validity in a digital intervention study with a racially/ethnically diverse sample. | Through study completion, 1-2 months | |
Primary | 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 (a = .84 - .86) and validity, and it is commonly used in MBI research. | Through study completion, 1-2 months | |
Primary | 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 (a = .89 - .90) and validity in POC samples. | Through study completion, 1-2 months | |
Primary | 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 (a = .86 - .89) and has shown validity across different racial/ethnic groups. | Through study completion, 1-2 months | |
Secondary | Change in mindfulness | The 15-item Mindful Attention Awareness Scale (MAAS) measures mindfulness trait. Participants rate items using a scale ranging from 1 (Almost Always 1) to 6 (Almost Never) with higher scores indicating more mindfulness. The MAAS has shown good internal consistency (a = .80 - .87) during its development. | Through study completion, 1-2 months | |
Secondary | Change in self-Compassion | The 12-item Self-Compassion Scale, Short Form (SCS-SF) measures self-compassion trait. Participants rate items using a scale ranging from 1 (Almost Never) to 5 (Almost Always) with higher scores indicating more self-compassion. The SCS-SF has shown good internal consistency (a = .86) and validity in a sample with significant POC representation. | Through study completion, 1-2 months | |
Secondary | Change in experiential avoidance | The 15-item Brief Experiential Avoidance Questionnaire (BEAQ) measures experiential avoidance. Participants rate their responses in a scale ranging from 1 (Strongly Disagree) to 6 (Strongly Agree) with higher scores indicating higher experiential avoidance. The BAEQ has shown good internal consistency (a = .80 - .86) and construct validity. | Through study completion, 1-2 months | |
Secondary | Change in rumination | The 5-item Brooding subscale of the short version of the Ruminative Response Scale (RRS-SF) measures rumination. Participants rate their responses in a scale ranging from 1 (Almost Never) to 4 (Almost Always) with higher scores indicating more rumination. The RRS-SF Brooding subscale has shown adequate internal consistency (a = .79) and validity in studies with POC samples that experience discrimination. | Through study completion, 1-2 months | |
Secondary | Change in emotion suppression | The 4-item Expressive Suppression of the Emotion Regulation Questionnaire (ERQ) measures emotion suppression. Participants rate their responses on a scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree) with higher scores indicating more emotion suppression. The Expressive Suppression subscale of the ERQ has shown an adequate reliability (a = .68 - .76) and validity in samples with significant POC representation. | Through study completion, 1-2 months |
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