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临床试验/NCT07009977
NCT07009977终止不适用

Project BrEAtHe: Brothers, Reclaiming Emotional Awareness Tranquility Healing & Ex-istence): Disrupting Racism-related Stress, Trauma, & Problematic Substance Use

UConn Health1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年9月27日最近更新:
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
22
试验地点
1
主要终点
Daily Marijuana use levels

研究概览

简要总结

The purpose of this study is to create a program focused on mindfulness and stress reduction specifically tailored to young adult Black males.

详细描述

Project Brothers reclaiming Emotional Awareness, tranquility, Healing, and Ex-istence (BrEAtHe) is a research study to create a program focused on mindfulness and stress reduction specifically tailored to young adult Black males (18 to 29 years old) residing in Durham, NC and in Hartford, CT. The investigators plan to use a mobile app on a cell phone to better understand 'real-time' feedback of experiences of stress due to racism. The investigators are interested in learning about the recruitment and retention of Black males participating in mindfulness based practices. The investigators are also interested in receiving feedback about options to modify and scale a Mindfulness Based Stress Reduction intervention and its preliminary effects on reducing physical and emotional stress reactions and poor coping mechanisms like marijuana and alcohol use linked to everyday racism and discrimination.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age: 18-29
  • Ethnicity: non-Hispanic Black
  • Gender: Male
  • does not meet the DSM-V criteria for substance use disorder or dependence or severe post-traumatic stress disorder (PTSD);
  • Neighborhood Inclusion Criteria: must live in a high VAOD neighborhood in Durham County, NC, or North Hartford Promise Zone, CT and have resided in the selected neighborhood for at least 6 months.

排除标准

  • non-English speakers,
  • meet the DSM-V criteria for substance use disorder or dependence or severe post-traumatic stress disorder (PTSD);
  • men of other racial/ethnic groups;
  • neighborhood outside of high VAOD neighborhood in Durham County, NC or North Hartford Promise Zone, CT.

研究组 & 干预措施

Group based MBSR training with BrEAtHe App (No Feedback)

Experimental

self-guided mHealth app only

干预措施: self-guided mHealth app only (Behavioral)

Group based MBSR training with BrEAtHe App (Feedback)

Experimental

self-guided mHealth app + 'real-time' feedback.

干预措施: self-guided mHealth app + 'real-time' feedback (Behavioral)

结局指标

主要结局

Daily Marijuana use levels

时间窗: immediately before and after the intervention

Daily marijuana use will be assessed with ecological momentary assessment (EMA). Participants will be asked to respond to random digital prompts on a handheld mobile device about recent substance use. Questions will include "Within the past hour, have you: (used marijuana)?" The response anchors for these questions will be "NO" or "YES." To classify alcohol or marijuana use confirmed with a "YES" response as problematic, The Drug Abuse Screening Test (DAST-10) will be administered. A separate summed score will be created for alcohol and marijuana use levels based on DSM-V criteria with higher scores indicating more problematic alcohol or marijuana use.

Daily Alcohol use levels

时间窗: immediately before and after the intervention

Daily alcohol use will be assessed with ecological momentary assessment (EMA). Participants will be asked to respond to random digital prompts on a handheld mobile device about recent alcohol use (drank alcohol)?" The response anchors for these questions will be "NO" or "YES." To classify alcohol or marijuana use confirmed with a "YES" response as problematic, The Alcohol Use Disorders Identification Test (AUDIT-C) will be administered. A separate summed score will be created for alcohol and marijuana use levels based on DSM-V criteria with higher scores indicating more problematic alcohol or marijuana use.

Daily Racism-Related and General Stress

时间窗: immediately before and after the intervention

Daily racism-related and general stress will be assessed with questions about asked the occurrence and impact of stress related to general experiences (i.e., had money troubles; argued with spouse or partner; had transportation problems) and those attributed to experiences of everyday racism (i.e., been followed by police officers or neighborhood security patrols because of your race). The response anchors for these questions will be "NO" or "YES." The impact of these experiences will be rated on a 5-point scale (1=not at all to 5=very stressful). Higher scores on these measures indicate more frequent and impactful stress experiences. Participants will also be asked to initiate an entry when they experience an impactful everyday racism or general stress experience at times not coinciding with Random Digital Prompts or RDPs (also called event-contingent entries)

次要结局

  • Trauma Symptomatology(immediately before and after the intervention)
  • Affect Regulation (i.e., emotion suppression)(immediately before and after the intervention)
  • Stress Reactivity (i.e., Heart Rate Variability (HRV))(immediately before and after the intervention)
  • Acceptability (User Satisfaction, Intent to Continue, Perceived Appropriateness, Fit, & Demand of Use)(immediately after the intervention)

研究者

发起方
UConn Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wizdom Powell

Director of Health Disparities Institute, Associate Professor of Psychiatry

UConn Health

研究点 (1)

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