Yoga and Female Concussion

NCT07170488 | Completed Results

• 2 other identifiers: STUDY23090017K01NS121199
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion Mild

Keywords

female; women; concussion

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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

  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

  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)

Other Outcomes (4)

• 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)

• 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)

• 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)

Study Arms (2)

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

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.

Behavioral: Yoga for wait list control

Interventions

Yoga BEHAVIORAL

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.)

Also known as: LoveYourBrain Yoga

Yoga group

Yoga for wait list control BEHAVIORAL

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

Wait List Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• PINK Concussions: collaborator
• LoveYourBrain Foundation: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Pittsburgh, DGIM

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• 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.

  PMID: 31577456 BACKGROUND

• Callahan 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.

  PMID: 36692090 BACKGROUND

• Donnelly 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.

  PMID: 27936953 BACKGROUND

Related Links

• PINK Concussions. PINK concussions: Female brain injury from sports, violence, military service

MeSH Terms

Conditions

Brain Concussion

Interventions

Yoga

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Limitations and Caveats

This was a quasi-experimental feasibility pilot study with a targeted sample size of 30, and 16 completed (5 Yoga, 11 controls). The study is not sufficiently powered for statistical tests of significance of the primary and secondary outcome measures. Results may inform larger trials.

Results Point of Contact

• Title: Martina Anto-Ocrah
• Organization: University of Pittsburgh

maa509@pitt.edu

4123352862

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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 Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: November 10, 2023
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: December 10, 2025
• Results First Posted: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)