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临床试验/NCT05830773
NCT05830773已完成不适用

Resonance Breathing Opioid Use Disorder

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Average rating of participant satisfaction with the app as assessed by the Acceptability of Intervention Measure

研究概览

简要总结

This study aims to assess the feasibility of an intervention for the management of craving, stress, anxiety, and depression among people who use opioids via a resonance breathing smartphone app.

详细描述

Most evidence-based treatments for substance use disorders (SUD) require face-to-face interactions with individuals who comprise a recovery support network. However, in the moment relapse occurs, people in recovery are often not in the presence of these trusted individuals. This project aims to address this issue by providing people in recovery with an application (app) that can be added to phones and other mobile devices to help them manage cravings, anxiety, and stress triggers at the specific moments they feel compelled to use. The connection between an individuals mind and body works in both directions. Psychological distress can cause psychosomatic symptoms in the body (e.g., stress is related to multiple chronic health conditions), but individuals can also use their bodies to affect psychology aspects (e.g., exercise can improve mood by releasing endorphins). A similar scientific theory is the foundation of controlled breathing interventions for anxiety, stress, and drug cravings. Psychological distress can disrupt the balance of our Autonomic Nervous System (which is responsible for our fight or flight response to threat), but breathing exercises can restore balance and decrease stress. The goal of this study is to test the feasibility, utility, and efficacy of an app that delivers controlled breathing exercises.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be eligible, participants need to be the legal age of majority (18 years of age or older), have the ability to read and speak in English, and have a history of alcohol or illicit drug use.

排除标准

  • Individuals with no access to a smartphone phone with a data plan, inability to provide consent and having suicidal thoughts or psychotic episodes.

结局指标

主要结局

Average rating of participant satisfaction with the app as assessed by the Acceptability of Intervention Measure

时间窗: 8 weeks

The measure has 4 items on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores are better outcomes. The citation for the measure is Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci 2017; 12(1):108.

Average rating of participant assessment of whether the app was easy and practical to use as assessed by the Feasibility of Intervention Measure.

时间窗: 8 weeks

Feasibility entails participant assessment of whether the app was easy and practical to use. The measure has 4 items on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores are better outcomes. The citation for the measure is Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci 2017; 12(1):108.

Average rating of participant assessment that the app is appropriate for managing cravings, stress, and anxiety as assessed by the Intervention Appropriateness Measure

时间窗: 8 weeks

The measure has 4 items on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores are better outcomes. The citation for the measure is Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci 2017; 12(1):108.

次要结局

  • Average rating of participant assessment of their frequency of drug craving as assessed by the Aggregated Drug Craving Scale.(8 weeks)
  • Average rating of participant assessment of their frequency of experieincing stress as assessed by the Peceived Stress Scale.(8 weeks)
  • Average rating of participant assessment of their frequency of experieincing anxiety as measured by the Beck Anxiety Inventory.(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fiona Conway

Assistant Professor

University of Texas at Austin

研究点 (2)

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