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Completed

NCT Number: NCT05850533

Tai Chi Easy for Opioid Use Disorder, Anxiety, and Chronic Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asana Recovery

Costa Mesa, California, 92627, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Virtual Tai Chi Easy

Behavioral

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.

Primary outcomes

  1. Participant Recruitment benchmark

    Time frame: 2 months

    recruit 20 adults within 2 months

  2. Participant Retention benchmark

    Time frame: 8 weeks

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

  3. Data Collection benchmark

    Time frame: 8 weeks

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

  4. Intervention Adherence benchmark

    Time frame: 8 weeks

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

  5. Intervention Acceptability, Appropriateness and Feasibility

    Time frame: 8 weeks

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

  6. Intervention Safety benchmark

    Time frame: 8 weeks

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

Secondary outcomes

  1. perceptions of the virtual tai chi easy

    Time frame: week 9-10 of study

    conducting a virtual focus group interview post-virtual tai chi easy, participants (n=8-10) will generate feedback on the virtual tai chi easy intervention

  2. Generalized anxiety

    Time frame: pre (week 0) and post (week 9)

    General Anxiety Disorder- 7 items (GAD-7)

  3. Chronic pain

    Time frame: pre (week 0) and post (week 9)

    Graded Chronic Pain Scale (GCPS)

  4. Opioid cravings

    Time frame: pre (week 0) and post (week 9)

    opioid cravings (OC-VAS scale)

  5. Basic Psychological Needs

    Time frame: pre (week 0) and post (week 9)

    Basic Psychological Needs Satisfaction (BPNS)

  6. Opioid use

    Time frame: pre (week 0) and post (week 9)

    Changes in opioid use will be collected via a urine drug screen with opioid results (biomarker of opioid use) from the outpatient clinic and reported to PI

Sponsors and collaborators

Lead sponsor

Asana Recovery

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 9, 2023
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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