NCT06146218

Brief Summary

The primary aim of this study is to explore the feasibility, acceptability, and preliminary effectiveness of CBRT intervention among African Americans compared to a wait-list control group. The specific objectives include assessing feasibility, gathering participant feedback, evaluating CBRT's impact on psychological and biological outcomes, and exploring the mediating role of mindfulness. The study is a 1-group pretest-posttest design. 20 African American participants will be recruited from various sources and undergo baseline and follow-up assessments. The intervention involves a 10-week CBRT program focusing on mindfulness, compassion, self-awareness, and stress-reduction techniques. Measures include sociodemographics and psychological measures (race-based stress, depression, perceived stress, quality of life, social connectedness, sleep, and resilience) and biological measures ( allostatic load, saliva cortisol, telomere length, and gene expression. Data is collected at baseline and 10 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2024

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 9, 2026

Completed
Last Updated

April 9, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

November 17, 2023

Results QC Date

November 14, 2025

Last Update Submit

March 21, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Feasibility of Study

    number of participants who complete the study

    10 weeks

  • Acceptability of CBRT (Qualitative Interview Findings)

    Acceptability was assessed using structured qualitative exit interviews conducted post-intervention. Interview transcripts were reviewed using structured thematic coding. Predefined themes reflecting participant experience were identified, including expectations alignment, perceived usefulness of meditation/emotional regulation tools, facilitator support, group dynamics, session structure, and behavioral impact. For reporting purposes, the number of participants who explicitly endorsed each theme during the interview was counted. Participants could endorse more than one theme; therefore, totals across themes do not sum to the overall sample size. Endorsement reflects a clear expression of agreement, perceived benefit, or experience related to the theme during qualitative analysis.

    at the end of the 10 week intervention

Secondary Outcomes (4)

  • Allostatic Load Composite Score (NHANES Clinically Relevant Scoring 0-11 )

    Baseline (pre-CBT) to 10 weeks (post-CBT)

  • Cortisol Awakening Response (CAR)

    Baseline (Pre-CBRT) and 10 weeks (Post-CBRT)

  • Composite CTRA Gene Expression Score

    comparison from baseline (pre-CBT) to 10 weeks (post-CBT)

  • Telomere Length

    10 weeks

Study Arms (1)

Contemplative-Based Resilience Training (CBRT)

EXPERIMENTAL

The intervention group will undergo a 10-week program addressing mindfulness, compassion, social-emotional self-care, exposing stress-reactive habits, self-awareness, visualization, and deep breathing.

Behavioral: Contemplative-Based Resilience Training (CBRT)

Interventions

The intervention is a 10-week program that will address mindfulness, compassion, social-emotional self-care, exposing stress-reactive habits, self-awareness, visualization, and deep breathing. The rationale for applying this mindfulness intervention to promote psychological resilience following the development of race-based traumatic symptoms is based on the notion that mindfulness promotes acceptance of complex thoughts and feelings, reduces rumination, and improves psychological function, cognitive flexibility, and coping processes.

Contemplative-Based Resilience Training (CBRT)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Self Identity as African American or Black
  • years old
  • Fluent in English

You may not qualify if:

  • History of significant pre-existing brain disease or injury (e.g., dementia, stroke, seizure disorder, and head injury with cognitive sequelae or loss of consciousness more than 30 minutes, seizure disorder)
  • Reported history of learning disability/mental retardation
  • Current Attention Deficit Hyperactive Disorder (ADHD), depression, bipolar disorder, post-traumatic stress disorder (PTSD), or psychotic disorder diagnosis
  • Current psychotropic medication (as these medications are known impacts on brain function) e.g. antipsychotics, antianxiety
  • Severe/chronic medical illness (e.g., reported HIV+ status, cardiovascular disease, liver disease/cirrhosis, chronic kidney disease, current/past cancer with radiation/chemotherapy treatment, etc.)
  • Current methadone/suboxone/buprenorphine (or similar) maintenance
  • Use of illicit substances other than cannabis within the past 90 days
  • Pregnant
  • Major life events in the last 30 days (hospitalization, marriage, death in the family of friends, disaster)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recrutment Office

New York, New York, 10065, United States

Location

Related Publications (12)

  • Paradies Y, Ben J, Denson N, Elias A, Priest N, Pieterse A, Gupta A, Kelaher M, Gee G. Racism as a Determinant of Health: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 23;10(9):e0138511. doi: 10.1371/journal.pone.0138511. eCollection 2015.

    PMID: 26398658BACKGROUND
  • Geronimus AT, Hicken M, Keene D, Bound J. "Weathering" and age patterns of allostatic load scores among blacks and whites in the United States. Am J Public Health. 2006 May;96(5):826-33. doi: 10.2105/AJPH.2004.060749. Epub 2005 Dec 27.

    PMID: 16380565BACKGROUND
  • Clark US, Miller ER, Hegde RR. Experiences of Discrimination Are Associated With Greater Resting Amygdala Activity and Functional Connectivity. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Apr;3(4):367-378. doi: 10.1016/j.bpsc.2017.11.011. Epub 2017 Dec 8.

    PMID: 29628069BACKGROUND
  • Brody GH, Lei MK, Chae DH, Yu T, Kogan SM, Beach SRH. Perceived discrimination among African American adolescents and allostatic load: a longitudinal analysis with buffering effects. Child Dev. 2014 May-Jun;85(3):989-1002. doi: 10.1111/cdev.12213. Epub 2014 Feb 5.

    PMID: 24673162BACKGROUND
  • Tull ES, Sheu YT, Butler C, Cornelious K. Relationships between perceived stress, coping behavior and cortisol secretion in women with high and low levels of internalized racism. J Natl Med Assoc. 2005 Feb;97(2):206-12.

    PMID: 15712783BACKGROUND
  • Carter RT, Muchow C. Construct validity of the Race-Based Traumatic Stress Symptom Scale and tests of measurement equivalence. Psychol Trauma. 2017 Nov;9(6):688-695. doi: 10.1037/tra0000256. Epub 2017 Feb 6.

    PMID: 28165267BACKGROUND
  • Wei M, Alvarez AN, Ku TY, Russell DW, Bonett DG. Development and validation of a Coping with Discrimination Scale: factor structure, reliability, and validity. J Couns Psychol. 2010 Jul;57(3):328-44. doi: 10.1037/a0019969.

    PMID: 21133583BACKGROUND
  • McEwen BS. Stress, adaptation, and disease. Allostasis and allostatic load. Ann N Y Acad Sci. 1998 May 1;840:33-44. doi: 10.1111/j.1749-6632.1998.tb09546.x.

    PMID: 9629234BACKGROUND
  • Williams DR, Yan Yu, Jackson JS, Anderson NB. Racial Differences in Physical and Mental Health: Socio-economic Status, Stress and Discrimination. J Health Psychol. 1997 Jul;2(3):335-51. doi: 10.1177/135910539700200305.

    PMID: 22013026BACKGROUND
  • Zapolski TCB, Faidley MT, Beutlich M. The Experience of Racism on Behavioral Health Outcomes: The Moderating Impact of Mindfulness. Mindfulness (N Y). 2019 Jan;10(1):168-178. doi: 10.1007/s12671-018-0963-7. Epub 2018 Jun 4.

    PMID: 30854146BACKGROUND
  • Saban KL, Motley D, Shawahin L, Mathews HL, Tell D, De La Pena P, Janusek LW. Preliminary evidence for a race-based stress reduction intervention for Black women at risk for cardiovascular disease. Complement Ther Med. 2021 May;58:102710. doi: 10.1016/j.ctim.2021.102710. Epub 2021 Mar 13.

    PMID: 33727090BACKGROUND
  • Cole SW. The Conserved Transcriptional Response to Adversity. Curr Opin Behav Sci. 2019 Aug;28:31-37. doi: 10.1016/j.cobeha.2019.01.008. Epub 2019 Feb 25.

    PMID: 31592179BACKGROUND

MeSH Terms

Conditions

RacismStress, Psychological

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial DiscriminationBehavioral Symptoms

Limitations and Caveats

Telomere length assays were not performed due to funding constraints. As a result, no telomere data are available for analysis or reporting in this study.

Results Point of Contact

Title
Rachel W. Kimani
Organization
Rockefeller University

Study Officials

  • Rachel W Kimani, DNP

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 24, 2023

Study Start

February 15, 2024

Primary Completion

August 9, 2024

Study Completion

August 9, 2024

Last Updated

April 9, 2026

Results First Posted

April 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations