Yoga and Female Concussion

University of Pittsburgh

Status: Completed

Conditions: Concussion Mild

Treatments: Behavioral: Yoga for wait list control; Behavioral: Yoga

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07170488

STUDY23090017

K01NS121199 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Most research on the impact of mild Traumatic Brain Injury/Concussions have been deficit-based and focused on the impairments induced by the injury. Research shows that trauma doesn't always have negative effects. While some people suffer, others may experience positive psychological changes. This is known as posttraumatic growth (PTG), which refers to the positive changes that can come from struggling with a life-changing event. In this study, the investigators explore if pilot yoga intervention improves PTG scores for women who have had concussions.

Full description

The investigators will be collaborating with the Pink Concussion network on this endeavor to recruit study participants who are residents of United States. PINK is an online support network for women with concussion symptoms lasting ≥1 month. PINK participants will be recruited online using an IRB approved consent form that will be on the study's landing page. Upon clicking the survey invitation link, potential survey takers will be brought to the very first page of the survey which will be the IRB-approved consent page. This will list the risks, benefits, incentives, and overall research processes. The consent will also state that the research is no greater than minimal risk and involves procedures for which written consent is normally not required outside of the research context. After reviewing the approved information sheet, participants will be prompted to consent yes in order to move on to the survey body. Those who do not consent will be sent to a "Thank you page" and not continue. Those who do so, will begin the survey. All survey questions will be voluntary and responses will be de-identified and analyzed in aggregate to ensure anonymity.

The Yoga intervention will be administered by LoveYourBrain Yoga, a US-based global non-profit organization that aims to improves the quality of life of people affected by traumatic brain injury through Yoga and meditation, education and other brain-health initiatives.

Thirty PINK participants will be randomly selected to participate in the LYB Yoga intervention. The Yoga sessions will be virtual and study participants will be able to complete these sessions at home. The session will not be recorded. They will be free of cost for the study participants. Yoga that will be taught is a simple form of exercise that is tailored to people with a history of TBI. The movements are slow and study participants will have the choice to participate up to their comfort level.The role of LoveYourBrain will be to administer the yoga intervention and will not be engaged in the research study.

The investigators will administer the Post-Traumatic Growth surveys again at 7 weeks and 30 days to 15 Yoga and 15 Wait list controls. The 15 Yoga participants will also do the post-yoga assessments at 7 weeks (1 week post-yoga). The 15 Wait list controls will do the LYB program after the 30-day PTG surveys have been completed. The 15 Wait list controls will receive a follow up survey, 1 week after the completion of the LYB program. The intervention group participants who have attended 3 or more LYB yoga sessions will also receive a week-20 follow up survey. Total evaluations will be at 1 week, 5 weeks and 20 weeks post-yoga

Because all participants will be receiving the Yoga intervention eventually (using a sequential design), allocation will be on a first come, first serve basis. After the n=15 has been reached for the Yoga, those still interested and available will be put in the wait-list control group to also receive the Yoga after the original Yoga group has finished all intervention activities.

Enrollment: 27 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for ALL PINK participants (STEP 1):

• 18 years of age or older
• Assigned female at birth
• Belongs to PINK Concussion Facebook group from as a concussion survivor
• Should be a resident of United States

Exclusion Criteria:

• Does not consent to study

To be included in YOGA intervention from STEP 1, they should:

1. Have low PTG (PGI-X score <75)
2. Be inexperienced/novice yoga users
3. Not be receiving rehab services

Exclusion Criteria:

• Does not consent to study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Yoga group

Experimental group

Description:

The Yoga group were assigned to a six-week, evidence-based, light intensity Yoga and meditation curriculum developed for individuals living with TBI. The intervention is delivered online and synchronously, the program is led by experienced instructors with more than a decade of teaching experience in Yoga. Each weekly session is 75 minutes and combines gentle postures, guided breathing exercises (pranayama), Yoga nidra (deep relaxation), and meditation practices. Before each of the Yoga sessions, participants are e-mailed prerecorded tools that focused on a specific theme for the week

Treatment:

Behavioral: Yoga

Wait List Control Group

Other group

Description:

This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group.

Treatment:

Behavioral: Yoga for wait list control