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

Not Applicable
Completed
Conditions
Stress, Psychological
Racism
Interventions
Behavioral: Contemplative-Based Resilience Training (CBRT)
Registration Number
NCT06146218
Lead Sponsor
Rockefeller University
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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
22
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Contemplative-Based Resilience Training (CBRT)Contemplative-Based Resilience Training (CBRT)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.
Primary Outcome Measures
NameTimeMethod
Feasibility of study10 weeks

percentage of participants who complete the study

Qualitative themes of participants perspectives on CBRT Intervention10 weeks

A thematic analysis of qualitative interviews to identify recurring themes. Interviews using semistructured questions will be conducted to understand participants' perspectives regarding their experiences of the intervention. Participants will be asked questions regarding the intervention, experiences of the sessions, features of the intervention, likes and dislikes, and changes experienced. Interviews will be conducted at the end of the 10-week intervention period for each group to assess the acceptability of the CBRT program.

Secondary Outcome Measures
NameTimeMethod
Allostatic load composite score (NHANES Clinically Relevant Scoring 0-11 )10 weeks

The allostatic score is calculated as a composite of 11 biomarkers. The cut points are determined by pre-established values in clinical medicine and generate three categories: high-risk (1 point), moderate-risk (0.5 points), and low-risk (0 points). High scores indicate a more significant risk.

Systolic BP≥ 150 mmHg, 120 to 149 mmHg, and \< 120 mmHg Diastolic BP ≥ 90 mmHg, 80 to 89 mmHg, and \< 80 mmHg Total cholesterol ≥ 240 mg/dL, 200 to 239 mg/dL, and \< 200 mg/dL HDL cholesterol \< 40 mg/dL, 40 to 59 mg/dL, and \> 60 mg/dL Total/HDL cholesterol ratio≥ 6, 5 to \< 6, and \< 5 Glycated hemoglobin≥ 6.5%, 5.7 to \< 6.5%, and \< 5.7% Waist-hip ratio (women) ≥ 0.85, \> 0.80 to \< 0.85, and ≤ 0.80 Waist-hip ratio (men) ≥ 1.0, \> 0.95 to \< 1.0, and ≤ 0.95 Body mass index≥ 30 kg/m2, 25 to \< 30 kg/m2, and 18 to \< 25 kg/m2 Albumin\< 3%, 3 to \< 3.8%, and ≥ 3.8% Creatinine clearance\< 30 mL/min/, 30 to \< 60 mL/min, and ≥ 60 mL/min/ C-reactive protein \> 3 mg/L, 1 to 3 mg/L, and \< 1 mg/L

Telomere Length10 weeks

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

Concentrations of pro-inflammatory gene expression Response to Adversity (CTRA)10 weeks

Gene expression measures of immune system function will be collected via PAXgene tubes. Analyses will focus on a priori-specified gene regulation pattern involving increased expression of inflammation-related genes and decreased expression of antiviral genes - a pattern called the conserved transcriptional response to adversity.

Salivary Cortisol-AUCAfter baseline, 3 timepoints at waking, 30minutes after waking, and at bedtime. In a 24 hour period

Samples will be collected using the passive drool technique using swabs and tubes. Participants will be instructed to gather saliva samples 3 times in one day: at waking, 30 minutes after waking, and at bedtime. Participants will be instructed not to eat, drink, or brush their teeth during the 30 minutes before sample collection times. Salivary cortisol will be analyzed using area-under-the-curve (AUC)

Trial Locations

Locations (1)

Recrutment Office

🇺🇸

New York, New York, United States

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