Recruiting

ACTIVE

Sponsor:

University of Pittsburgh

Code:

NCT06819904

Conditions

Concussion, Mild

Mild Traumatic Brain Injury (mTBI)

Psychological Health

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Not accepted

Interventions

Acceptance and Commitment Therapy Integrated Rehabilitation (ACT)

Usual Care Rehabilitation

Study Details

Brief summary:

The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Rehabilitation (ACT) with usual care rehabilitation (CONTROL) in 250 individuals with mTBI-related symptoms attributable to mild traumatic brain injury (mTBI) treated at one of two sites (1) the University of Pittsburgh Medical Center, or (2) the Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Hood, Texas. Both interventions will be delivered weekly over 4 weeks. Assessments will be administered prior to the start of treatment (Baseline) and at 4-weeks, 3- and 6-months following the completion of treatment.

Conditions

Concussion, Mild

Mild Traumatic Brain Injury (mTBI)

Psychological Health

Study ID

NCT06819904

Start date

Feb 27, 2025

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18-49 years of age
  • Normal/corrected vision
  • Diagnosed with mTBI per military clinical practice guidelines (CPGs) that occurred over 8 days prior to consent as determined by a multi-domain assessment performed by a licensed healthcare professional.
  • mTBI-related symptoms and/or impairments in at least one or more areas, including vestibular (dizziness, imbalance), psychological health (anxiety, depression, stress), cognitive (memory problems), headache/migraine, ocular, or sleep. as determined by self-report.

Exclusion Criteria:

  • History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction) as determined by patient self-report.
  • History of neurological disorder (e.g., epilepsy, multiple sclerosis) as determined by self-report.
  • Cervical spine injury or dysfunction (i.e., limited range of motion; ROM) as determined by self-report.
  • Previous moderate to severe TBI as determined by self-report.
  • < 8 days following current mTBI as determined by self-report.
  • Currently pregnant as determined by self-report.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acceptance and Commitment Therapy Integrated Rehabilitation (ACT)

The ACT intervention group will receive Acceptance and Commitment Therapy (ACT) + usual care rehabilitation exercises and behavioral management during four weekly in person sessions along with daily at-home activities during the 4 week treatment period. The four ACT sessions will last 60 minutes each and will include: 1) values clarification and goal setting; 2) skills training in psychological flexibility including emotional acceptance, cognitive defusion, and present moment awareness; and 3) practice engaging these skills to overcome mental obstacles to values-driven goal attainment.

active comparator: Usual Care Rehabilitation (CONTROL)

The CONTROL group will receive standard of care evaluations and treatments involving a holistic multidisciplinary approach, but will exclude any ACT components. Because usual standard of care is individualized to the patient's unique functional deficits, treatments may focus on any one or more of the following: vestibular, rehabilitation, neuro-optometry, neuropsychology, physical and occupational therapy, or speech and language pathology, or general mental health interventions such as instruction regarding stress reduction. The usual care intervention will be coordinated by a primary treating clinician and additional specialty care providers as indicated by the participant's evaluation, individualized patient goals, and concomitant treatments.

Interventions

Acceptance and Commitment Therapy Integrated Rehabilitation (ACT)

Participants will receive the ACT treatment. It is comprised of three processes: Open Up, Be Present, and Do What Matters. Each of these is further sub-divided, for a total of six core processes. These processes include, but are not limited to, present moment awareness, de-fusion, and committed action. This group will also receive targeted vestibular therapy and standardized behavioral management strategies (physical activity, sleep, hydration, and nutrition prescription). Participants will also receive usual care at the discretion of each site's treating providers.

Usual Care Rehabilitation

Participants will receive usual care treatment at the discretion of each site's treating providers, excluding any components associated with ACT. Because usual standard of care is individualized to the patient's unique functional deficits, treatments may focus on any one or more of the following: vestibular rehabilitation, neuro-optometry, neuropsychology, physical and occupational therapy, or speech and language pathology, or general mental health interventions.

Primary outcome measure

  • Generalized Anxiety Disorder (GAD-7) [ Time Frame: Baseline, 4-week, 3-month, 6-month study visits ]
  • Neurobehavioral Symptom Inventory (NSI) [ Time Frame: Baseline, 4-week, 3-month, 6-month study visits ]

Central Contacts and Locations

Central contacts

Locations

University of Pittsburgh Concussion Research Laboratory

Recruiting

Pittsburgh, Pennsylvania, United States, 15213-4512

Contacts

More Information

Sponsor

University of Pittsburgh

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • concussion
  • mTBI
  • psychological health
  • treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-06-30.