Yoga and Female Concussion

Post Traumatic Growth After Concussion in Women

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07170488

Enrollment

Registered

2025-09-12

Start date

2023-11-10

Completion date

2024-04-24

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion Mild

Keywords

female, women, concussion

Brief summary

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.

Detailed 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.

Interventions

BEHAVIORALYoga

The LoveYourBrain (LYB) Yoga program is a six-week, evidence-based, light intensity Yoga and meditation curriculum developed for individuals living with TBI. It 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 (resilience, mindfulness etc.)

BEHAVIORALYoga for wait list control

After the active Yoga group received the intervention, the wait list control was then assigned to the intervention.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Post Traumatic Growth	Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)	Post Traumatic Growth Inventory (PTGI-X). Scores range from 0-125, with higher scores indicating greater post traumatic growth. Scores ≥75 is used as cutoff for moderate to high PTG; and scores \<75 are deemed low PTG

Secondary

Measure	Time frame	Description
Female Sexual Function Index-6 (FSFI-6)	Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)	To assess intimacy/relationships after brain injury. Consists of 6 questions related to sexual activity within the 4 weeks prior to the examination and includes sexual desire, sexual arousal, lubrication, orgasm, satisfaction, and pain. Scoring is based on Likert scoring from 0-5. Total scores range from 2-30 with lower scores corresponding to worse sexual functioning.
Resilience	Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)	Resilience will be measured using the 25-item Resilience Scale. Range of scores: 25 - 175; higher scores indicating greater resilience
Flourishing	Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)	This 12- item scale will be used to understand overall wellbeing before and after the intervention. The score is obtained by summing the scores from the twelve questions in all six domains and results in a score from 0 - 120. Scores are on a scale of 0-10. Higher scores are indicative of greater flourishing.

Other

Measure	Time frame	Description
Rivermead Post-Concussion Questionnaire	Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)	The investigators will use the Rivermead Post-Concussion Questionnaire to evaluate prevalence of persistent Post-concussion Symptoms among study participants. The RPQ is a 16-item self-report measure of the presence and severity of the 16 most commonly reported post-concussive symptoms observed in the literature. Values for each of the 16 items are ranked on a five-point scale (0 = not experienced at all, 4 = severe problem). Scores on the RPQ range from 0 to 64, with higher scores suggestive of greater PCS burden.
Anxiety	Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)	The investigators will use the General Anxiety Disorder (GAD-7) to evaluate prevalence of anxiety post-concussion using this brief 9-item screener. Participants respond to how often they have been bothered by symptoms, from 0 (not at all) to 3 (nearly every day).GAD-7 total score for the seven items ranges from 0 to 21, with higher scores suggestive of greater anxiety.
Depression	Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)	The investigators will use the Patient Health Questionnaire (PHQ-9) to evaluate prevalence of depression post-concussion among study participants. The Patient Health Questionnaire (PHQ-9) is a 9-item screener to assess the frequency of depressed mood/anhedonia over the past two weeks. Participants respond to how often they have been bothered by symptoms, from 0 (not at all) to 3 (nearly every day). Scores range from 0-27, with higher scores suggestive of greater depression.
Post Traumatic Stress Disorder (PTSD)	Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)	The investigators will use the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) (PCL-5) to evaluate prevalence of PTSD among study participants. This is a well-validated 20-item scale that assesses symptoms mirrored from the diagnostic criteria for PTSD in the DSM-V. Participants rate the extent that symptoms have bothered them in the past month on a 5-point scale from 0-4, with total scores ranging from 0-80 and higher scores indicating greater symptom severity.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Yoga Group 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	12
Wait List Control Group This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group.	15
Total	27

Baseline characteristics

Characteristic	Wait List Control Group	Total	Yoga Group
Age, Continuous	35.8 Years	40.8 Years	46.6 Years
Race/Ethnicity, Customized Black/AA	5 Participants	6 Participants	1 Participants
Race/Ethnicity, Customized Hispanic	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized White	10 Participants	20 Participants	10 Participants
Sex: Female, Male Female	15 Participants	27 Participants	12 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 12	0 / 15
other Total, other adverse events	0 / 12	0 / 15
serious Total, serious adverse events	0 / 12	0 / 15

Outcome results

Primary

Post Traumatic Growth

Post Traumatic Growth Inventory (PTGI-X). Scores range from 0-125, with higher scores indicating greater post traumatic growth. Scores ≥75 is used as cutoff for moderate to high PTG; and scores \<75 are deemed low PTG

Time frame: Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions)