NCT05850533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

May 22, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

April 25, 2023

Last Update Submit

October 11, 2023

Conditions

Opioid Use DisorderChronic PainAnxiety

Keywords

Mind-body therapyOpioid use disorderChronic painAnxietyTai Chi Easy

Outcome Measures

Primary Outcomes (6)

  • Participant Recruitment benchmark

    recruit 20 adults within 2 months

    2 months

  • Participant Retention benchmark

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

    8 weeks

  • Data Collection benchmark

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

    8 weeks

  • Intervention Adherence benchmark

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

    8 weeks

  • 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

  • Intervention Safety benchmark

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

    8 weeks

Secondary Outcomes (6)

  • perceptions of the virtual tai chi easy

    week 9-10 of study

  • Generalized anxiety

    pre (week 0) and post (week 9)

  • Chronic pain

    pre (week 0) and post (week 9)

  • Opioid cravings

    pre (week 0) and post (week 9)

  • Basic Psychological Needs

    pre (week 0) and post (week 9)

  • +1 more secondary outcomes

Study Arms (1)

Tai Chi Easy Intervention

EXPERIMENTAL

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

Behavioral: Virtual Tai Chi Easy

Interventions

Virtual Tai Chi EasyBEHAVIORAL

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.

Tai Chi Easy Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asana Recovery

Costa Mesa, California, 92627, United States

Location

Related Publications (1)

  • Coffee Z, Badger TA, Taylor-Piliae R, Vanderah TW, Yu CH, Gordon JS. Tai Chi Easy for Opioid Use Disorder: Pilot Feasibility Outcomes and Lessons Learned. J Integr Complement Med. 2025 Nov;31(11):979-986. doi: 10.1177/27683605251360930. Epub 2025 Jul 18.

    PMID: 40681321DERIVED

MeSH Terms

Conditions

Opioid-Related DisordersChronic PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 9, 2023

Study Start

May 22, 2023

Primary Completion

October 11, 2023

Study Completion

October 11, 2023

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)