Concussion MildNCT07170488
Yoga and Female Concussion
A study testing Yoga in people with Concussion Mild, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Concussion Mild
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2023to 24 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not consent to study
- To be included in YOGA intervention from STEP 1, they should:
- Have low PTG (PGI-X score <75)
- Be inexperienced/novice yoga users
- Not be receiving rehab services
- Does not consent to study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh, DGIM
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Post Traumatic Growth After Concussion in Women
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.
Read the 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.
- Conditions
- Concussion Mild
- Being tested
- Yoga, Yoga for wait list control
- Keywords
- female, women, concussion
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Also called LoveYourBrain Yoga
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.)
Yoga for wait list controlBehavioural
After the active Yoga group received the intervention, the wait list control was then assigned to the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Yoga group | Experimental | 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 Receives: Behavioral: Yoga |
| Wait List Control Group | Other | This is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group. Receives: Behavioral: Yoga for wait list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Secondary outcomes (3)
Female Sexual Function Index-6 (FSFI-6)
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.
Measured: 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
Resilience will be measured using the 25-item Resilience Scale. Range of scores: 25 - 175; higher scores indicating greater resilience
Measured: 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)
Flourishing
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start10 Nov 2023
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Concussion MildStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- PINK Concussions, LoveYourBrain Foundation, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Martina Anto-Ocrah, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170488
- Sponsor's protocol ID
- STUDY23090017
- Other IDs
- K01NS121199
- Status last verified
- Nov 2025
- First submitted
- 5 Sep 2025
- Last updated
- 10 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be analyzed in aggregate and there is no plans to share participant data individually. We must protect their identity and ensure data anonymity and confidentiality. This is particularly important given the small sample sizes. Upon reasonable request from the PI, Dr. Anto-Ocrah, the data will be shared in aggregate.
Publications
Donnelly KZ, Baker K, Pierce R, St Ivany AR, Barr PJ, Bruce ML. A retrospective study on the acceptability, feasibility, and effectiveness of LoveYourBrain Yoga for people with traumatic brain injury and caregivers. Disabil Rehabil. 2021 Jun;43(12):1764-1775. doi: 10.1080/09638288.2019.1672109. Epub 2019 Oct 2.
PubMed 31577456Callahan CE, Beisecker L, Zeller S, Donnelly KZ. LoveYourBrain Mindset: Feasibility, Acceptability, Usability, and Effectiveness of an Online Yoga, Mindfulness, and Psychoeducation Intervention for People with Traumatic Brain Injury. Brain Inj. 2023 Apr 16;37(5):373-382. doi: 10.1080/02699052.2023.2168062. Epub 2023 Jan 24.
PubMed 36692090Donnelly KZ, Linnea K, Grant DA, Lichtenstein J. The feasibility and impact of a yoga pilot programme on the quality-of-life of adults with acquired brain injury. Brain Inj. 2017;31(2):208-214. doi: 10.1080/02699052.2016.1225988. Epub 2016 Dec 12.
PubMed 27936953
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Traumatic Growth After Concussion in Women
- ClinicalTrials.gov ID
- NCT07170488
- Acronym / sponsor ID
- STUDY23090017
- Conditions
- Concussion Mild
- Keywords
- female, women, concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- PINK Concussions, LoveYourBrain Foundation, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 12 Sep 2025 (actual)
- Results
- Posted 10 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Yoga group | Experimental | Behavioral: YogaThe 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 |
| Wait List Control Group | Other | Behavioral: Yoga for wait list controlThis is the wait list control group that got the Yoga intervention after data collection was completed for the Yoga group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Does not consent to study
- Have low PTG (PGI-X score <75)
- Be inexperienced/novice yoga users
- Not be receiving rehab services
- Does not consent to study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaAlso: LoveYourBrain YogaThe 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.) | Behavioural | Yoga group |
| Yoga for wait list controlAfter the active Yoga group received the intervention, the wait list control was then assigned to the intervention. | Behavioural | Wait List Control Group |
Primary outcome
Post Traumatic Growth
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)
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
3 secondary outcomes
Female Sexual Function Index-6 (FSFI-6)
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)
Resilience
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)
Flourishing
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31577456Donnelly KZ, Baker K, Pierce R, St Ivany AR, Barr PJ, Bruce ML. A retrospective study on the acceptability, feasibility, and effectiveness of LoveYourBrain Yoga for people with traumatic brain injury and caregivers. Disabil Rehabil. 2021 Jun;43(12):1764-1775. doi: 10.1080/09638288.2019.1672109. Epub 2019 Oct 2.
- Background: PubMed 36692090Callahan CE, Beisecker L, Zeller S, Donnelly KZ. LoveYourBrain Mindset: Feasibility, Acceptability, Usability, and Effectiveness of an Online Yoga, Mindfulness, and Psychoeducation Intervention for People with Traumatic Brain Injury. Brain Inj. 2023 Apr 16;37(5):373-382. doi: 10.1080/02699052.2023.2168062. Epub 2023 Jan 24.
- Background: PubMed 27936953Donnelly KZ, Linnea K, Grant DA, Lichtenstein J. The feasibility and impact of a yoga pilot programme on the quality-of-life of adults with acquired brain injury. Brain Inj. 2017;31(2):208-214. doi: 10.1080/02699052.2016.1225988. Epub 2016 Dec 12.
- PINK Concussions. PINK concussions: Female brain injury from sports, violence, military serviceLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be analyzed in aggregate and there is no plans to share participant data individually. We must protect their identity and ensure data anonymity and confidentiality. This is particularly important given the small sample sizes. Upon reasonable request from the PI, Dr. Anto-Ocrah, the data will be shared in aggregate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Concussion Mild, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Traumatic Growth (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07170488, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.