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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03720600
Other study ID # 2018026
Secondary ID 1R36MH116678-01
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2018
Est. completion date June 1, 2020

Study information

Verified date September 2021
Source University of Massachusetts, Boston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The project aims to evaluate a brief intervention for coping with racism-related experiences for people of color and examine momentary factors that may buffer the negative mental health impact of racism.


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MAB Intervention
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.

Locations

Country Name City State
United States University of Massachusetts Boston Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
University of Massachusetts, Boston National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Depression Anxiety and Stress Scale scores 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 Momentary changes in Positive And Negative Affect Scale 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
Secondary Quantitative measure of intervention helpfulness 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
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