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临床试验/NCT05850533
NCT05850533已完成不适用

Pilot Feasibility of a Virtual Tai Chi Easy Intervention for Opioid Use Disorder, Anxiety, and Chronic Pain

Asana Recovery2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2023年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
2
主要终点
Participant Recruitment benchmark

研究概览

简要总结

A pre-post, single-group, quasi-experimental design will be used to determine the acceptability, feasibility, and appropriateness of a theory-based, 8-week/16-session virtual Tai Chi Easy (vTCE) intervention for adults with OUD, anxiety, and chronic pain. This dissertation has three Aims: 1) Determine the feasibility of an 8-week/16-session, vTCE intervention for adults with OUD, CP, and anxiety; 2) Determine the perceptions of the vTCE intervention participants by conducting a focus group interview post-vTCE; 3) Explore within-subject changes in generalized anxiety, chronic pain intensity, opioid use, opioid cravings, and basic psychological needs post-vTCE.

详细描述

This study will determine the feasibility of a virtual Tai Chi Easy (vTCE) intervention for adults with opioid use disorder (OUD), chronic pain (CP), and anxiety. OUD is a public health crisis that causes more than 130 deaths daily, costs over $78 billion annually, and disproportionately affects persons with CP and anxiety. CP and anxiety are important contributors to treatment discontinuation and relapse. Interventions that treat the overlapping symptoms of OUD, anxiety, and CP, concurrently, may improve OUD outcomes. Medication Assisted Treatment (MAT) (e.g., Suboxone) is the most common intervention for OUD; yet MAT is underutilized and approximately 50% of people discontinue treatment prematurely or relapse. There is a small but growing body of literature demonstrating that mind-body therapies (e.g., mindfulness, acupuncture, Tai Chi) help improve opioid use, anxiety, pain, self-efficacy, stress, and quality of life. Unique to other mind-body therapies, Tai Chi Easy (TCE) is multi-component mind-body therapy including: 1) Gentle movement, 2) Breath practice, 3) Self-massage, and 4) Meditation. However, the feasibility of vTCE to ameliorate anxiety and CP symptoms among individuals with OUD is not known. This pilot study addresses this gap by examining the feasibility of a vTCE intervention for OUD, CP, and anxiety. A pre-post single-group quasi-experimental design of adults (N=20) with OUD, CP, and anxiety will be recruited from a substance use treatment facility in California. Aim 1, determine the feasibility of an 8-week/16-session, vTCE intervention for adults with OUD, CP, and anxiety using the following benchmarks: a) recruit 20 adults within 2 months, b) at least 75% study retention, c) 80% of data collected, d) at least 80% adherence to vTCE, e) an average rating of 4.0 on intervention acceptability, appropriateness, and feasibility (i.e., three valid 4-item measures, 5-point Likert scale), and f) 0% safety or injury issues during vTCE classes. Aim 2, determine the perceptions of vTCE intervention by conducting a focus group (FG) interview post-vTCE. FG participants (n=8-10) will generate feedback on the vTCE intervention. Aim 3: Explore within-subject changes in generalized anxiety, chronic pain intensity, opioid use, opioid cravings, and basic psychological needs post-vTCE. Exploratory outcome measures will be collected via REDCap at two intervals (pre-vTCE/Week 0) and (post-vTCE/Week 9). Self-report exploratory measures will be collected using the General Anxiety Disorder (GAD-7), chronic pain intensity (GCPS), opioid cravings (OC-VAS scale), and Basic Psychological Needs Satisfaction (BPNS). Changes in opioid use will be collected via urinalysis with a biomarker of opioid use from the outpatient clinic and reported to the principal investigator. A new holistic theoretical framework (Complexity of Opioid Use Disorder Model) will guide this project. Quantitative data will be analyzed using linear regression and Crist and Tanner's five interpretive phases will be used to analyze qualitative data. Results from this study will provide a foundation for conducting a randomized controlled feasibility trial to test vTCE for individuals with OUD, anxiety, and CP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • male and female adults 18 years and older
  • diagnosed with opioid use disorder and have a coexisting condition (e.g., anxiety AND/OR chronic pain)
  • able to read and comprehend 5th grade English and provide informed consent.

排除标准

  • subjects cognitively impaired
  • active psychosis or current substance use condition requiring a level of care higher than outpatient treatment
  • unable to complete study measures.

结局指标

主要结局

Participant Recruitment benchmark

时间窗: 2 months

recruit 20 adults within 2 months

Intervention Adherence benchmark

时间窗: 8 weeks

at least 80% adherence to the interventions with class attendance recorded

Participant Retention benchmark

时间窗: 8 weeks

at least 75% study retention, with reasons for attrition collected

Intervention Acceptability, Appropriateness and Feasibility

时间窗: 8 weeks

an average rating of 4.0 intervention acceptability, appropriateness, and feasibility (i.e., three valid 4-item measures, 5-point Likert scale)

Data Collection benchmark

时间窗: 8 weeks

80% of data collected, with reasons for missing data or other data collection issues identified

Intervention Safety benchmark

时间窗: 8 weeks

0% safety or injury issues during virtual tai chi classes.

次要结局

  • Opioid cravings(pre (week 0) and post (week 9))
  • perceptions of the virtual tai chi easy(week 9-10 of study)
  • Chronic pain(pre (week 0) and post (week 9))
  • Basic Psychological Needs(pre (week 0) and post (week 9))
  • Generalized anxiety(pre (week 0) and post (week 9))
  • Opioid use(pre (week 0) and post (week 9))

研究者

发起方
Asana Recovery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhanette Coffee

Principal Investigator

Asana Recovery

研究点 (2)

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