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

Primary Purpose

Opioid Use Disorder, Chronic Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Tai Chi Easy
Sponsored by
Asana Recovery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring Mind-body therapy, Opioid use disorder, Chronic pain, Anxiety, Tai Chi Easy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Asana Recovery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tai Chi Easy Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Participant Recruitment benchmark
recruit 20 adults within 2 months
Participant Retention benchmark
at least 75% study retention, with reasons for attrition collected
Data Collection benchmark
80% of data collected, with reasons for missing data or other data collection issues identified
Intervention Adherence benchmark
at least 80% adherence to the interventions with class attendance recorded
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)
Intervention Safety benchmark
0% safety or injury issues during virtual tai chi classes.

Secondary Outcome Measures

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
Generalized anxiety
General Anxiety Disorder- 7 items (GAD-7)
Chronic pain
Graded Chronic Pain Scale (GCPS)
Opioid cravings
opioid cravings (OC-VAS scale)
Basic Psychological Needs
Basic Psychological Needs Satisfaction (BPNS)
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

Full Information

First Posted
April 25, 2023
Last Updated
October 11, 2023
Sponsor
Asana Recovery
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1. Study Identification

Unique Protocol Identification Number
NCT05850533
Brief Title
Tai Chi Easy for Opioid Use Disorder, Anxiety, and Chronic Pain
Official Title
Pilot Feasibility of a Virtual Tai Chi Easy Intervention for Opioid Use Disorder, Anxiety, and Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
October 11, 2023 (Actual)
Study Completion Date
October 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asana Recovery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Chronic Pain, Anxiety
Keywords
Mind-body therapy, Opioid use disorder, Chronic pain, Anxiety, Tai Chi Easy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi Easy Intervention
Arm Type
Experimental
Arm Description
8-week/16-session virtual Tai Chi Easy (vTCE) intervention for adults with OUD, anxiety, and chronic pain
Intervention Type
Behavioral
Intervention Name(s)
Virtual Tai Chi Easy
Intervention Description
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 Outcome Measure Information:
Title
Participant Recruitment benchmark
Description
recruit 20 adults within 2 months
Time Frame
2 months
Title
Participant Retention benchmark
Description
at least 75% study retention, with reasons for attrition collected
Time Frame
8 weeks
Title
Data Collection benchmark
Description
80% of data collected, with reasons for missing data or other data collection issues identified
Time Frame
8 weeks
Title
Intervention Adherence benchmark
Description
at least 80% adherence to the interventions with class attendance recorded
Time Frame
8 weeks
Title
Intervention Acceptability, Appropriateness and Feasibility
Description
an average rating of 4.0 intervention acceptability, appropriateness, and feasibility (i.e., three valid 4-item measures, 5-point Likert scale)
Time Frame
8 weeks
Title
Intervention Safety benchmark
Description
0% safety or injury issues during virtual tai chi classes.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
perceptions of the virtual tai chi easy
Description
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
Time Frame
week 9-10 of study
Title
Generalized anxiety
Description
General Anxiety Disorder- 7 items (GAD-7)
Time Frame
pre (week 0) and post (week 9)
Title
Chronic pain
Description
Graded Chronic Pain Scale (GCPS)
Time Frame
pre (week 0) and post (week 9)
Title
Opioid cravings
Description
opioid cravings (OC-VAS scale)
Time Frame
pre (week 0) and post (week 9)
Title
Basic Psychological Needs
Description
Basic Psychological Needs Satisfaction (BPNS)
Time Frame
pre (week 0) and post (week 9)
Title
Opioid use
Description
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
Time Frame
pre (week 0) and post (week 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Asana Recovery
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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