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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05850533
• Other study ID #: STUDY00002492
• Status: Completed
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: October 11, 2023

Study information

• Verified date: October 2023
• Source: Asana Recovery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 11, 2023
• Est. primary completion date: October 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Chronic Pain
• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Asana Recovery	Costa Mesa	California

Sponsors (1)

Lead Sponsor	Collaborator
Asana Recovery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Recruitment benchmark	recruit 20 adults within 2 months	2 months
Primary	Participant Retention benchmark	at least 75% study retention, with reasons for attrition collected	8 weeks
Primary	Data Collection benchmark	80% of data collected, with reasons for missing data or other data collection issues identified	8 weeks
Primary	Intervention Adherence benchmark	at least 80% adherence to the interventions with class attendance recorded	8 weeks
Primary	Intervention Acceptability, Appropriateness and Feasibility	an average rating of 4.0 intervention acceptability, appropriateness, and feasibility (i.e., three valid 4-item measures, 5-point Likert scale)	8 weeks
Primary	Intervention Safety benchmark	0% safety or injury issues during virtual tai chi classes.	8 weeks
Secondary	perceptions of the virtual tai chi easy	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	week 9-10 of study
Secondary	Generalized anxiety	General Anxiety Disorder- 7 items (GAD-7)	pre (week 0) and post (week 9)
Secondary	Chronic pain	Graded Chronic Pain Scale (GCPS)	pre (week 0) and post (week 9)
Secondary	Opioid cravings	opioid cravings (OC-VAS scale)	pre (week 0) and post (week 9)
Secondary	Basic Psychological Needs	Basic Psychological Needs Satisfaction (BPNS)	pre (week 0) and post (week 9)
Secondary	Opioid use	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	pre (week 0) and post (week 9)