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

Study Overview
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Brief Summary
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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 employs a randomized two-arm crossover trial design with a wait-list control group. Participants are 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. The waitlist group will be engaged using a short weekly online survey. Measures include socio-demographics and psychological measures (racism-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, ten weeks, and 20 weeks.

Detailed Description
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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 employs a randomized two-arm crossover trial design with a waitlist control group. Participants are 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. The waitlist group will be engaged using a short weekly online survey. Measures include socio-demographics 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, ten weeks, and 20 weeks. 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.

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

Conditions
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Racism, Stress, Psychological

Intervention / Treatment
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* Behavioral: Contemplative-Based Resilience Training (CBRT)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A-Contemplative-Based Resilience Training (CBRT) then Online Survey<br>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. After 10 weeks, they will switch to the No intervention group. | Behavioral: Contemplative-Based Resilience Training (CBRT)<br>* 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.<br>|
| Experimental: Group B-Online Survey then Contemplative-Based Resilience Training (CBRT)<br>The control group will be engaged by having them fill out a weekly online survey sent to their phone. The purpose of the survey is to keep participants not receiving intervention engaged in the study. Investigators will not be analyzing the results of this survey. After 10 weeks, they will switch to the intervention. | Behavioral: Contemplative-Based Resilience Training (CBRT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of study | percentage of participants who complete the study | 10 weeks | 
| Qualitative themes of participants perspectives on CBRT Intervention | 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. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allostatic load composite score (NHANES Clinically Relevant Scoring 0-11 ) | 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 | 10 weeks | 
| Telomere Length | Quantitative Polymerase Chain Reaction (RT-PCR )will determine average telomere length. | 10 weeks | 
| Salivary Cortisol-AUC | 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) | After baseline, 3 timepoints at waking, 30minutes after waking, and at bedtime. In a 24 hour period | 
| Concentrations of pro-inflammatory gene expression Response to Adversity (CTRA) | 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. | 10 weeks |