Clinical trial NCT06146218: Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress
Official title: Effects of Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress Among African Americans: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Racism
Stress, Psychological
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of study
timeFrame: 10 weeks
measure: Qualitative themes of participants perspectives on CBRT Intervention
timeFrame: 10 weeks
Secondary outcomes:
measure: Allostatic load composite score (NHANES Clinically Relevant Scoring 0-11 )
timeFrame: 10 weeks
measure: Telomere Length
timeFrame: 10 weeks
measure: Salivary Cortisol-AUC
timeFrame: After baseline, 3 timepoints at waking, 30minutes after waking, and at bedtime. In a 24 hour period
measure: Concentrations of pro-inflammatory gene expression Response to Adversity (CTRA)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Recrutment Office
state: New York
Study officials:
affiliation: Rockefeller University
name: Rachel W Kimani, DNP
role: PRINCIPAL_INVESTIGATOR
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