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

Sponsor
Rockefeller University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06146218
Collaborator
(none)
40
1
2
6
6.7

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Contemplative-Based Resilience Training (CBRT
N/A

Detailed Description

Racism and racial discrimination profoundly affect mental and physical health among minoritized 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 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 (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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress Among African Americans: A Pilot Study
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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
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. Our 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 ofcomplex thoughts and feelings, reduces rumination, and improves psychological function, cognitive flexibility, and coping processes

Experimental: Group B

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. We will not be analyzing the results of this survey. After 10 weeks, they will switch to the intervention.

Behavioral: Contemplative-Based Resilience Training (CBRT
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. Our 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 ofcomplex thoughts and feelings, reduces rumination, and improves psychological function, cognitive flexibility, and coping processes

Outcome Measures

Primary Outcome Measures

  1. Feasibility of study [10 weeks]

    percentage of participants who complete the study

  2. Qualitative evaluation of participants perspectives on CBRT Intervention [10 weeks]

    Qualitative interviews using semistructured questions will be conducted to understand participants' perspectives regarding experiences of the intervention.

Secondary Outcome Measures

  1. Allostatic load composite score [10 weeks]

    The Allostatic score was calculated as a composite of these 10 biomarkers focused on the metabolic, renal, and immune physiologic systems. A Biomarkers from the metabolic system included body mass index (BMI) (kg/m2), albumin, and alkaline phosphatase. The renal system biomarkers were creatinine and creatinine clearance, and immune system biomarkers were C-reactive protein (CRP) and white blood cell count (WBC). The cut points are determined by pre-established values in clinical medicine and generate three categories: high-risk (1 point), moderate- risk (0.5 point), and low-risk (0 points)

  2. Telomere Length [10 weeks]

    Quantitative RT-PCR will be used to determine average telomere length

  3. Salivary Cortisol-AUC [After baseline, 3 timepoints at waking, 30min after waking, and at bedtime. In a 24 hour period]

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

  4. Concentrations of pro-inflammatory gene expression Response to Adversity (CTRA) [10 weeks]

    Gene expression measures of immune system function will be collected via Paxegene 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 >30 min.ute, 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 have known impacts on brain function) eg. 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Recrutment Office New York New York United States 10065

Sponsors and Collaborators

  • Rockefeller University

Investigators

  • Principal Investigator: Rachel W Kimani, DNP, Rockefeller University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rockefeller University
ClinicalTrials.gov Identifier:
NCT06146218
Other Study ID Numbers:
  • RKI-1047
First Posted:
Nov 24, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2023