Psychological DistressFORDNCT03720600
Forms of Racial Discrimination Study
A study testing MAB Intervention in people with Psychological Distress, run by University of Massachusetts, Boston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- MAB Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2018to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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(score of 24 or higher on the Racial Microaggressions Scale; this score is 1 SD deviation below the mean in an unpublished dataset from a study conducted at the same institution)
Who cannot join
- Has lived in the U.S. for less than 5 years
- Not fluent in English
- Identifies as White, European American
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Boston
Boston, Massachusetts, 02125
About this study
Official title: Examination of a Mindfulness- and Acceptance-Based Health Promotion Program on Momentary Experiences of Racism and Mental Health Outcomes
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.
Read the 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.
- Conditions
- Psychological Distress
- Being tested
- MAB Intervention
- Keywords
- mindfulness, acceptance, racism
- Medical subject headings
- Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAB InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: MAB Intervention |
| No-EMA Control | No intervention | Participants in the "No-EMA Control" condition will only complete questionnaires at T1 and T2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and two weeks later
Secondary outcomes (2)
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.
Measured: four times a day for two weeks
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.
Measured: Two weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start26 Sep 2018
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jennifer Martinez, University of Massachusetts, Boston
- Investigators
- Jennifer H. Martinez, M.A., Principal investigator, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720600
- Sponsor's protocol ID
- 2018026
- Other IDs
- 1R36MH116678-01
- Acronym
- FORD
- Status last verified
- Sep 2021
- First submitted
- 22 Oct 2018
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of a Mindfulness- and Acceptance-Based Health Promotion Program on Momentary Experiences of Racism and Mental Health Outcomes
- ClinicalTrials.gov ID
- NCT03720600
- Acronym / sponsor ID
- FORD / 2018026
- Conditions
- Psychological Distress
- Keywords
- mindfulness, acceptance, racism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MAB Intervention | Experimental | Behavioral: MAB InterventionParticipants 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. |
| Waitlist-Control | Other | Behavioral: MAB InterventionParticipants 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. |
| No-EMA Control | No intervention | –Participants in the "No-EMA Control" condition will only complete questionnaires at T1 and T2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Has lived in the U.S. for less than 5 years
- Not fluent in English
- Identifies as White, European American
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAB InterventionThe 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. | Behavioural | MAB Intervention, Waitlist-Control |
Primary outcome
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.
2 secondary outcomes
Momentary changes in Positive And Negative Affect Scale
Time frame: four times a day for two weeks
Quantitative measure of intervention helpfulness
Time frame: Two weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer H. Martinez, M.A. principal investigator
University of Massachusetts, Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAB Intervention in people with Psychological Distress, run by University of Massachusetts, Boston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression Anxiety and Stress Scale scores (time frame: Baseline and two weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.