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Completed

NCT Number: NCT06146218

Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recrutment Office

New York, 10065, United States

About this study

Racism and racial discrimination profoundly affect mental and physical health among historically disenfranchised ethnic groups, including Black, Indigenous, and People of Color (BIPOC). The negative health impacts are evident in elevated mortality rates, early disease onset, and increased comorbidity burden among BIPOC individuals. This study seeks to address these health disparities by investigating the potential of Contemplative-Based Resilience Training (CBRT) to mitigate the impact of racism-related stress. CBRT holds promise in countering the neurobiological changes attributed to chronic stress, aligning with the "weathering hypothesis" and Allostatic load theory.

The primary aim of this pilot study is to explore the feasibility, acceptability, and preliminary effectiveness of CBRT intervention among African Americans compared to a waitlist 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 utilizes a one-group pretest-posttest design, where participants are recruited from various sources and undergo baseline and follow-up assessments. The intervention involves a ten-week Cognitive-Based Resilience Training (CBRT) program focusing on developing mindfulness, compassion, self-awareness, and stress-reduction techniques. The study measures include socio-demographics and psychological measures such as race-based stress, depression, perceived stress, quality of life, social connectedness, sleep, and resilience, as well as biological measures including allostatic load, saliva cortisol, telomere length, and gene expression. Data is collected at baseline and after ten weeks of the program.

Feasibility will be assessed based on recruitment rates, retention, attendance, and qualitative feedback. The impact of CBRT will be evaluated through various statistical analyses, considering intention-to-treat principles and controlling for covariates. Preliminary findings from a pilot investigation with 20 African-American participants suggest associations between psychological measures, mindfulness, sleep, coping, resilience, and racism-induced stress. These results underscore the potential of CBRT in addressing complex relationships among these factors. By investigating the potential benefits of CBRT in alleviating racism-induced stress and associated health disparities, this research aims to contribute insights into mindfulness-based interventions to address racism-related stress and its broader implications for the well-being of BIPOC communities.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self Identity as African American or Black
  • 18-50 years old
  • Fluent in English

Exclusion criteria

  • 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)

Treatment and study plan

Contemplative-Based Resilience Training (CBRT)

Behavioral

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.

Primary outcomes

  1. Feasibility of Study

    Time frame: 10 weeks

    number of participants who complete the study

  2. Acceptability of CBRT (Qualitative Interview Findings)

    Time frame: at the end of the 10 week intervention

    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.

Secondary outcomes

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

    Time frame: Baseline (pre-CBT) to 10 weeks (post-CBT)

    Allostatic load score is a composite score based on eleven biomarkers. Risk categories for the level of each biomarker are defined and points, high (Hi) (1 point), moderate (Mod) (0.5 points), or low (low) (0 points), are awarded based on established norms in clinical medicine. Allostatic Load is the sum of the points from the 11 biomarkers. High scores indicate a more significant risk.

    • SBP: Hi ≥ 150 mmHg, Mod 120 to 149 mmHg, Low < 120 mmHg; 2) DBP: Hi ≥ 90 mmHg, Mod 80 to 89 mmHg, Low < 80 mmHg; 3) Total cholesterol: Hi ≥ 240 mg/dL, Mod 200 to 239 mg/dL, Low < 200 mg/dL; 4) HDL cholesterol: Hi < 40 mg/dL, Mod 40 to 59 mg/dL, Low > 60 mg/dL; 5) Total/HDL cholesterol ratio: Hi ≥ 6, Mod 5 to < 6, Low < 5; 6) HgbA1C: Hi ≥ 6.5%, Mod 5.7 to < 6.5%, Low < 5.7%; 7) Waist-hip ratio (women): Hi ≥ 0.85, Mod > 0.80 to < 0.85, Low ≤ 0.80; Waist-hip ratio (men): Hi ≥ 1.0, Mod > 0.95 to < 1.0, Low ≤ 0.95; 8); BMI: Hi ≥ 30 kg/m2, Mod 25
  2. Cortisol Awakening Response (CAR)

    Time frame: Baseline (Pre-CBRT) and 10 weeks (Post-CBRT)

    Cortisol Awakening Response (CAR) was calculated as the difference between salivary cortisol concentration measured 30 minutes after awakening and at waking (µg/dL). Positive values reflect a physiologic increase in cortisol following awakening.

  3. Composite CTRA Gene Expression Score

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

    CTRA gene expression was assessed using genome-wide transcriptional profiling of peripheral blood samples. Expression levels of 45 pre-specified CTRA indicator genes were quantified as log2-transformed mRNA abundance values. Gene expression values were mean-centered and weighted using established contrast scores reflecting pro-inflammatory and antiviral gene contributions. A composite CTRA score was calculated by averaging the weighted expression values across all genes, with higher scores indicating greater pro-inflammatory and lower antiviral gene expression activity.

  4. Telomere Length

    Time frame: 10 weeks

    Quantitative Polymerase Chain Reaction (PCR )will determine average telomere length.

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Registry information

Official study title

Effects of Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress Among African Americans: A Pilot Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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