Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase I (YOGAMAT-II)

August 19, 2022 updated by: Butler Hospital

Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in Treatment for Opioid Use Disorder - Phase I

Phase 1 - MOST Preparation Phase:

  1. To conduct a pilot trial at two opioid use disorder clinic sites, enrolling n=10 at both sites, for a total n=20.
  2. Establish clinical trial procedures and document feasibility at both sites prior to conducting a fully powered optimization trial.
  3. Demonstrate our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer components; d) run classes; and e) collect follow-up assessments.

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

In Phase 1, we will enroll 10 participants at each recruitment site (n=20). The purpose of Phase 1 (MOST Preparation Phase) is to allow us to establish and refine procedures at these new sites and document aspects of feasibility, including our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer these components; d) run classes; and e) collect follow-up assessments. Enrollment period for this phase will last approximately 4 months.

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.
20

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 Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02909
        • CODAC Behavioral Healthcare

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Enrolled in methadone maintenance (MMT) or buprenorphine/naloxone (BUP) treatment for > 3 months
  • Plan to continue treatment for next 6 months
  • Chronic pain, defined as pain for at least half the days over the previous three months, a mean score of 4 or higher on the Brief Pain Interference Scale (BPI; with reference to chronic pain), and pain severity of 4 or higher on a Visual Analog Scale (0-10) indicating "worst pain in the last week." Pain severity score will also refer to the areas of their body in which they have chronic pain.
  • Aged > 18
  • Proficiency in English sufficient to engage in informed consent in English, understand classes taught in English, and read short sentences
  • Available at least one of the times study classes are offered.

Exclusion Criteria:

  • Currently taking yoga classes or practicing yoga at home once per week or more often.
  • Medical conditions that would make participation in yoga unsafe or not possible, including active malignancy treatment, fracture, recent joint surgery, use of assistive ambulatory devices other than a cane. . (In cases where this is unclear, site PI will make final determination based on available evidence.)
  • Severe or progressive neurologic deficits. (In cases where this is unclear, site PI will make final determination based on available evidence.)
  • Other severe disabling chronic medical and/or psychiatric comorbidities deemed by the site PI on a case-by-case basis to prevent safe or adequate participation in the study (e.g., cognitive impairment that prevents a participant from understanding assessments; history of disruptive behavior in medical settings; severe disabling heart failure or lung disease)
  • Surgery requiring overnight hospitalization planned in the next 3 months
  • Pregnancy
  • Plan to move out of the area within 6 months.
  • Homeless, defined as any time in the past month sleeping in a shelter or on the street.

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: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

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.
Active Comparator: No Video/No One-on-One/No Text/No Incentive
This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, or financial Incentives to attend yoga classes
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: No Video/No One-on-One/No Text/Yes Incentive
This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, but DOES receive financial Incentives to attend yoga classes
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: No Video/No One-on-One/Yes Text/No Incentive
This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or financial Incentives to attend yoga classes, but DOES recieve prompting Text messages,
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: No Video/No One-on-One/Yes Text/Yes Incentive
This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, but DOES receive prompting Text messages, and financial Incentives to attend yoga classes
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: No Video/Yes One-on-One/No Text/No Incentive
This group does not receive Personal Practice Videos, or prompting Text messages, or financial Incentives to attend yoga classes, but DOES receive One-on-One individual sessions with a Yoga Instructor
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: No Video/Yes One-on-One/No Text/Yes Incentive
This group does not receive Personal Practice Videos, or prompting Text messages, but DOES receive financial Incentives to attend yoga classes and One-on-One individual sessions with a Yoga Instructor
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: No Video/Yes One-on-One/Yes Text/No Incentive
This group does not receive Personal Practice Videos, or financial Incentives to attend yoga classes, but DOES receive prompting Text messages and One-on-One individual sessions with a Yoga Instructor
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: No Video/Yes One-on-One/Yes Text/Yes Incentive
This group does not receive Personal Practice Videos, but DOES receive financial Incentives to attend yoga classes, prompting Text messages and One-on-One individual sessions with a Yoga Instructor
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: Yes Video/No One-on-One/No Text/No Incentive
This group does not receive financial Incentives to attend yoga classes, prompting Text messages or One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: Yes Video/No One-on-One/No Text/Yes Incentive
This group does not receive prompting Text messages or One-on-One individual sessions with a Yoga Instructor, but DOES receive financial Incentives to attend yoga classes and Personal Practice Videos
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: Yes Video/No One-on-One/Yes Text/No Incentive
This group does not receive financial Incentives to attend yoga classes, or One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos and prompting Text messages
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: Yes Video/No One-on-One/Yes Text/Yes Incentive
This group does not receive One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos, prompting Text messages and financial Incentives to attend yoga classes
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: Yes Video/Yes One-on-One/No Text/No Incentive
This group does not receive prompting Text messages or financial Incentives to attend yoga classes, but DOES receive One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: Yes Video/Yes One-on-One/No Text/Yes Incentive
This group does not receive prompting Text messages but DOES receive financial Incentives to attend yoga classes, One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: Yes Video/Yes One-on-One/Yes Text/No Incentive
This group does not receive financial Incentives to attend yoga classes, but DOES receive prompting Text messages, One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.
Active Comparator: Yes Video/Yes One-on-One/Yes Text/Yes Incentive
This group receives Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes
Behavioral: Yoga classes
All participants are invited to attend weekly yoga classes.

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
Number of Participants Recruited
Time Frame: 4 months
As this is a pilot study, a key outcome is number of participants recruited
4 months
Number of Yoga Teachers Trained to > 80% Fidelity to the Manual
Time Frame: 7 months
As this is a pilot study, an outcome is to assess whether we can train teachers to an acceptable level of fidelity
7 months
Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected
Time Frame: 3 months
As this is a pilot study, an outcome is percentage of weeks where data on amount of yoga personal practice were collected. The total number of weeks possible = 12. These data are most important as they will be used to derive the primary outcome in the next phase of this research (total amount of yoga practice.)
3 months

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.
Butler Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

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.
March 1, 2021

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.
November 1, 2021

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.
November 1, 2021

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).
November 12, 2020

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.
November 20, 2020

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.
November 27, 2020

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.
September 14, 2022

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.
August 19, 2022

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.
August 1, 2022

More Information

Terms related to this study

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.
  • 202002-002-1
  • U01AT010863 (U.S. NIH Grant/Contract)

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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