NCT03720600

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

October 22, 2018

Last Update Submit

September 2, 2021

Conditions

Keywords

mindfulnessacceptanceracism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Momentary changes in Positive And Negative Affect Scale

    four times a day for two weeks

  • Quantitative measure of intervention helpfulness

    Two weeks after baseline

Study Arms (3)

MAB Intervention

EXPERIMENTAL

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.

Behavioral: MAB Intervention

Waitlist-Control

OTHER

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.

Behavioral: MAB Intervention

No-EMA Control

NO INTERVENTION

Participants in the "No-EMA Control" condition will only complete questionnaires at T1 and T2.

Interventions

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.

MAB InterventionWaitlist-Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Has lived in the U.S. for less than 5 years
  • Not fluent in English
  • Identifies as White, European American

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Boston

Boston, Massachusetts, 02125, United States

Location

MeSH Terms

Conditions

Racism

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial Discrimination

Study Officials

  • Jennifer H. Martinez, M.A.

    University of Massachusetts, Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 25, 2018

Study Start

September 26, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

The proposed research will include data from approximately 100 subjects who will complete a coping with racism health promotion program and two-week momentary assessments at an urban university. The final dataset will include self-reported demographic, mood, and behavioral data from online questionnaires.

Shared Documents
STUDY PROTOCOL, ICF, CSR

Locations