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

Sponsor

Asana Recovery (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05850533

Collaborator

(none)

Enrollment

Location

Arm

6.4

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder Chronic Pain Anxiety	Behavioral: Virtual Tai Chi Easy	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 22, 2023

Anticipated Primary Completion Date :

Dec 4, 2023

Anticipated Study Completion Date :

Dec 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tai Chi Easy Intervention 8-week/16-session virtual Tai Chi Easy (vTCE) intervention for adults with OUD, anxiety, and chronic pain	Behavioral: Virtual Tai Chi Easy 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.

Arm

Intervention/Treatment

Experimental: Tai Chi Easy Intervention

8-week/16-session virtual Tai Chi Easy (vTCE) intervention for adults with OUD, anxiety, and chronic pain

Behavioral: Virtual Tai Chi Easy

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.

Outcome Measures

Primary Outcome Measures

Participant Recruitment benchmark [2 months]
recruit 20 adults within 2 months
Participant Retention benchmark [8 weeks]
at least 75% study retention, with reasons for attrition collected
Data Collection benchmark [8 weeks]
80% of data collected, with reasons for missing data or other data collection issues identified
Intervention Adherence benchmark [8 weeks]
at least 80% adherence to the interventions with class attendance recorded
Intervention Acceptability, Appropriateness and Feasibility [8 weeks]
an average rating of 4.0 intervention acceptability, appropriateness, and feasibility (i.e., three valid 4-item measures, 5-point Likert scale)
Intervention Safety benchmark [8 weeks]
0% safety or injury issues during virtual tai chi classes.

Secondary Outcome Measures

perceptions of the virtual tai chi easy [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
Generalized anxiety [pre (week 0) and post (week 9)]
General Anxiety Disorder- 7 items (GAD-7)
Chronic pain [pre (week 0) and post (week 9)]
Graded Chronic Pain Scale (GCPS)
Opioid cravings [pre (week 0) and post (week 9)]
opioid cravings (OC-VAS scale)
Basic Psychological Needs [pre (week 0) and post (week 9)]
Basic Psychological Needs Satisfaction (BPNS)
Opioid use [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.