Stress, Psychological Clinical Trial
Official title:
Effects of Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress Among African Americans: A Pilot Study
NCT number | NCT06146218 |
Other study ID # | RKI-1047 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 5, 2024 |
Est. completion date | May 31, 2024 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Recrutment Office | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Rockefeller University |
United States,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of study | percentage of participants who complete the study | 10 weeks | |
Primary | 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 | 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 | |
Secondary | Telomere Length | Quantitative Polymerase Chain Reaction (RT-PCR )will determine average telomere length. | 10 weeks | |
Secondary | 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 | |
Secondary | 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 |
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