Optimization and Multi-Site Feasibility of Yoga for Chron... | NCT04641221

NCT04641221

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
R01AT010863	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Video/No One-on-One/No Text/No Incentive	Active Comparator	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: Weekly Yoga Classes
No Video/No One-on-One/No Text/Yes Incentive	Active Comparator	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: Weekly Yoga Classes
No Video/No One-on-One/Yes Text/No Incentive	Active Comparator	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 receive prompting Text messages	Behavioral: Weekly Yoga Classes
No Video/No One-on-One/Yes Text/Yes Incentive	Active Comparator	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: Weekly Yoga Classes
No Video/Yes One-on-One/No Text/No Incentive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Weekly Yoga Classes	Behavioral	All participants are invited to attend weekly yoga classes.	No Video/No One-on-One/No Text/No Incentive No Video/No One-on-One/No Text/Yes Incentive

Measure	Description	Time Frame
Yoga Dosage	Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview	3 months

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Boston Medical Center		Boston	Massachusetts	02118	United States
CODAC Behavioral Healthcare

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38103784	Derived	Uebelacker LA, Braun TD, Taylor LE, Saper R, Baldwi M, Abrantes A, Tremont G, Toribio A, Kirshy S, Koch R, Lorin L, Van Noppen D, Anderson B, Roseen EJ, Stein MD. Evaluation of intervention components to maximize yoga practice among people with chronic pain taking opioid agonist therapy: A factorial experiment using the multiphase optimization strategy framework. Contemp Clin Trials. 2024 Feb;137:107411. doi: 10.1016/j.cct.2023.107411. Epub 2023 Dec 14.

Arm/Group Information

ID	Title	Description
FG000	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
FG001	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
FG002	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 receive prompting Text messages
FG003	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
FG004	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
FG005	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 One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes
FG006	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 One-on-One individual sessions with a Yoga Instructor and prompting Text messages
FG007	No Video/Yes One-on-One/Yes Text/Yes Incentive	This group does not receive Personal Practice Videos, but DOES receive One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes
FG008	Yes Video/No One-on-One/No Text/No Incentive	This group does not receive One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos
FG009	Yes Video/No One-on-One/No Text/Yes Incentive	This group does not receive One-on-One individual sessions with a Yoga Instructor or prompting Text messages, but DOES receive Personal Practice Videos and financial Incentives to attend yoga classes
FG010	Yes Video/No One-on-One/Yes Text/No Incentive	This group does not receive One-on-One individual sessions with a Yoga Instructor or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos and prompting Text messages
FG011	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
FG012	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 Personal Practice Videos and One-on-One individual sessions with a Yoga Instructor
FG013	Yes Video/Yes One-on-One/No Text/Yes Incentive	This group does not receive prompting Text messages, but DOES receive Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes
FG014	Yes Video/Yes One-on-One/Yes Text/No Incentive	This group does not receive financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor and prompting Text messages
FG015	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

Periods

Title

Milestones

Reasons Not Completed

First 3 months

Type	Comment	Milestone Data
STARTED		FG00012 subjects FG00112 subjects FG00212 subjects FG00312 subjects FG00412 subjects FG00512 subjects FG00612 subjects FG00712 subjects FG00812 subjects FG00912 subjects FG01012 subjects FG01112 subjects FG01212 subjects FG01312 subjects FG01412 subjects FG01512 subjects
COMPLETED		FG00010 subjects FG00111 subjects FG0029 subjects FG0039 subjects FG004
NOT COMPLETED		FG0002 subjects FG0011 subjects FG0023 subjects FG0033 subjects FG004

All 12 months

Type	Comment	Milestone Data
STARTED		FG00012 subjects FG00112 subjects FG00212 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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
BG001	No Video/No One-on-One/No Text/Yes Incentive

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous	Age in years

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Yoga Dosage

Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview

Posted

Mean

90% Confidence Interval

Total yoga Minutes

3 months

ID	Title	Description
OG000	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
OG001	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

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms