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临床试验/NCT06146218
NCT06146218
已完成
不适用

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

Rockefeller University2 个研究点 分布在 1 个国家目标入组 22 人2024年2月15日

概览

阶段
不适用
干预措施
Contemplative-Based Resilience Training (CBRT)
疾病 / 适应症
Racism
发起方
Rockefeller University
入组人数
22
试验地点
2
主要终点
Feasibility of study
状态
已完成
最后更新
23天前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2024年2月15日
结束日期
2024年8月9日
最后更新
23天前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Self Identity as African American or Black
  • 18-50 years old
  • Fluent in English

排除标准

  • 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
  • Major life events in the last 30 days (hospitalization, marriage, death in the family of friends, disaster)

研究组 & 干预措施

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.

干预措施: Contemplative-Based Resilience Training (CBRT)

结局指标

主要结局

Feasibility of study

时间窗: 10 weeks

percentage of participants who complete the study

Qualitative themes of participants perspectives on CBRT Intervention

时间窗: 10 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.

Feasibility of Study

时间窗: 10 weeks

number of participants who complete the study

Acceptability of CBRT (Qualitative Interview Findings)

时间窗: at the end of the 10 week intervention

Acceptability was assessed using structured qualitative exit interviews conducted post-intervention. Interview transcripts were reviewed using structured thematic coding. Predefined themes reflecting participant experience were identified, including expectations alignment, perceived usefulness of meditation/emotional regulation tools, facilitator support, group dynamics, session structure, and behavioral impact. For reporting purposes, the number of participants who explicitly endorsed each theme during the interview was counted. Participants could endorse more than one theme; therefore, totals across themes do not sum to the overall sample size. Endorsement reflects a clear expression of agreement, perceived benefit, or experience related to the theme during qualitative analysis.

次要结局

  • Allostatic load composite score (NHANES Clinically Relevant Scoring 0-11 )(10 weeks)
  • Telomere Length(10 weeks)
  • Concentrations of pro-inflammatory gene expression Response to Adversity (CTRA)(10 weeks)
  • Salivary Cortisol-AUC(After baseline, 3 timepoints at waking, 30minutes after waking, and at bedtime. In a 24 hour period)
  • Allostatic Load Composite Score (NHANES Clinically Relevant Scoring 0-11 )(Baseline (pre-CBT) to 10 weeks (post-CBT))
  • Cortisol Awakening Response (CAR)(Baseline (Pre-CBRT) and 10 weeks (Post-CBRT))
  • Composite CTRA Gene Expression Score(comparison from baseline (pre-CBT) to 10 weeks (post-CBT))

研究点 (2)

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