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

October 11, 2023 updated by: Zhanette Coffee, Asana Recovery

Pilot Feasibility of a Virtual Tai Chi Easy Intervention 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Costa Mesa, California, United States, 92627
        • Asana Recovery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participant Recruitment benchmark
Time Frame: 2 months
recruit 20 adults within 2 months
2 months
Participant Retention benchmark
Time Frame: 8 weeks
at least 75% study retention, with reasons for attrition collected
8 weeks
Data Collection benchmark
Time Frame: 8 weeks
80% of data collected, with reasons for missing data or other data collection issues identified
8 weeks
Intervention Adherence benchmark
Time Frame: 8 weeks
at least 80% adherence to the interventions with class attendance recorded
8 weeks
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)
8 weeks
Intervention Safety benchmark
Time Frame: 8 weeks
0% safety or injury issues during virtual tai chi classes.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
week 9-10 of study
Generalized anxiety
Time Frame: pre (week 0) and post (week 9)
General Anxiety Disorder- 7 items (GAD-7)
pre (week 0) and post (week 9)
Chronic pain
Time Frame: pre (week 0) and post (week 9)
Graded Chronic Pain Scale (GCPS)
pre (week 0) and post (week 9)
Opioid cravings
Time Frame: pre (week 0) and post (week 9)
opioid cravings (OC-VAS scale)
pre (week 0) and post (week 9)
Basic Psychological Needs
Time Frame: pre (week 0) and post (week 9)
Basic Psychological Needs Satisfaction (BPNS)
pre (week 0) and post (week 9)
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
pre (week 0) and post (week 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asana Recovery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00002492

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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