- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03720600
Forms of Racial Discrimination Study (FORD)
Examination of a Mindfulness- and Acceptance-Based Health Promotion Program on Momentary Experiences of Racism and Mental Health Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study focuses on the unique experiences of people of color (e.g., Asian American, Black/African American, Latinx, Native, Multiracial), ways they manage coping with race-related stress, as well as evaluating the effectiveness of a brief, one-hour intervention focused on coping with racism. First, the study will evaluate the acceptability and impact of a brief, single-session, 1-hour intervention aimed at addressing strategies for coping with racism compared to a waitlist-control condition. The intervention will integrate culturally-adapted approaches for enhancing compassionate awareness, emotional acceptance, valued actions, and coping flexibility (CAAVAF). The study will also evaluate whether the brief CAAVAF program will be associated with increased use of CAAVAF strategies (compassionate awareness, emotional acceptance, valued action, and coping flexibility) in response to racial discrimination over time and whether the brief CAAVAF program improves mental health outcomes at the two-week follow-up. Second, the study aims to evaluate the impact of CAAVAF strategies on mental health outcomes in response to momentary reports of coping with discrimination and from pre- to two-week follow-up.
All participants will be asked to complete an online screening questionnaire, which will include informed consent, demographic questionnaires, past experiences of discrimination, and trait measures of coping. Participants will be randomized into a.) a CAAVAF program, b.) a waitlist control condition with EMA, or c.) a control condition without the CAAVAF program or EMA. Participants in the CAAVAF condition will watch a scripted CAAVAF psychoeducation video during an initial laboratory session; in contrast, participants in the waitlist control condition will watch the video in a second session (after two weeks of ecological momentary assessment). Participants in both the CAAVAF program and waitlist control condition will be given instructions on using an EMA cellphone application during the initial session for repeated momentary assessments. Following this session, participants in the EMA conditions will monitor their experiences of discrimination over two weeks, and report their mood and strategies used. Participants will then return to the lab and complete a final battery of questionnaires and a qualitative exit-interview. Participants in the control condition will only complete pre questionnaires and questionnaires at a two-week follow-up.Study findings will contribute to the existing literature by evaluating whether CAAVAF strategies are effective buffers against racism-related mental health outcomes, and whether our CAAVAF and EMA program facilitates the use of these strategies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02125
- University of Massachusetts Boston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-identifies as a person of color (not white, European American)
- self-reported distress from racial microaggressions (score of 24 or higher on the Racial Microaggressions Scale; this score is 1 SD deviation below the mean in an unpublished dataset from a study conducted at the same institution)
Exclusion Criteria:
- Has lived in the U.S. for less than 5 years
- Not fluent in English
- Identifies as White, European American
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MAB Intervention
Participants in this condition will be asked to come into the laboratory twice.
At Time 1 (T1), participants in this condition will watch a voice-guided PowerPoint on MAB strategies for coping with discrimination.
For the following two weeks, they will be asked to complete multiple momentary assessments daily for two weeks.
After two weeks, participants will return to the laboratory to complete a final battery of questionnaires and complete a qualitative exit-interview.
|
The intervention is a 60-minute voice-recorded PowerPoint presentation on a mindfulness- and acceptance-based (MAB) intervention adapted from Eustis et al. (2017).
This adaptation was informed by research on MAB therapies and other approaches to coping with discrimination (e.g., Watson, Black, & Hunter, 2016), as well as clinical experience providing an in-person workshop on MAB strategies for coping with racism-related stress.
|
|
Other: Waitlist-Control
Participants in the "waitlist-control" condition will be asked to come into the laboratory twice.
At Time 1 (T1), participants in this condition will complete an initial set of questionnaires.
For the following two weeks, they will be asked to complete multiple daily momentary assessments daily.
After two weeks, participants will return to the laboratory to complete a final battery of questionnaires, watch a voice-guided PowerPoint on MAB strategies for coping with discrimination, and complete a qualitative exit-interview.
|
The intervention is a 60-minute voice-recorded PowerPoint presentation on a mindfulness- and acceptance-based (MAB) intervention adapted from Eustis et al. (2017).
This adaptation was informed by research on MAB therapies and other approaches to coping with discrimination (e.g., Watson, Black, & Hunter, 2016), as well as clinical experience providing an in-person workshop on MAB strategies for coping with racism-related stress.
|
|
No Intervention: No-EMA Control
Participants in the "No-EMA Control" condition will only complete questionnaires at T1 and T2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Depression Anxiety and Stress Scale scores
Time Frame: Baseline and two weeks later
|
21-item self-report measure of past-week depressive and anxious symptoms.
Each item is rated on a 4-point Likert scale (0= Did not apply to me at all, to 3= Applied to me very much or most of the time).
Subscale scores are summed, with higher scores indicating more persistent depressive or anxious symptoms.
|
Baseline and two weeks later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Momentary changes in Positive And Negative Affect Scale
Time Frame: four times a day for two weeks
|
20-item self-report measure of positive and negative emotions at the present moment.
Each item is rated on a 5-point Likert scale (1=very slightly or not at all to 5=extremely).
Subscale scores are summed, with higher scores indicating greater positive or negative affect.
|
four times a day for two weeks
|
|
Quantitative measure of intervention helpfulness
Time Frame: Two weeks after baseline
|
8-item measure developed by PI and colleagues to assess intervention helpfulness.
Items are rated on a 5-point Likert scale (1=extremely unhelpful/not at all helpful to 5=extremely helpful/definitely helpful).
Items will be summed, with higher scores indicating greater reports of helpfulness.
|
Two weeks after baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jennifer H. Martinez, M.A., University of Massachusetts, Boston
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018026
- 1R36MH116678-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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