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Acceptance and Commitment Therapy for Mild Traumatic Brain Injury (mTBI)

This study is testing a new approach called Acceptance and Commitment Therapy Integrated Rehabilitation (ACT) against usual care for people with mild traumatic brain injury (mTBI) and related symptoms. ACT helps you learn to be more present and do what matters, even with discomfort. Researchers want to see if ACT can improve symptoms like anxiety and other neurobehavioral issues better than standard care. You might be able to join if you are 18-49 years old, have normal or corrected vision, and were diagnosed with mTBI more than 8 days ago, with ongoing symptoms like dizziness or imbalance. The study aims to enroll 250 participants.

Study design
This is a randomized clinical trial, meaning participants will be assigned by chance to either the ACT treatment or usual care. The study plans to enroll 250 participants.
What's involved
You would receive weekly treatment over 4 weeks. You would also have assessments at the start of treatment, and then at 4 weeks, 3 months, and 6 months after treatment ends.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after completing treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06819904

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

Recruiting
NAAges 18–49InterventionalTreatment
University of Pittsburgh
~250 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Acceptance and Commitment Therapy Integrated Rehabilitation (ACT)Usual Care Rehabilitation

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Generalized Anxiety Disorder (GAD-7)
Measured over Baseline, 4-week, 3-month, 6-month study visits
+1 more outcome measured

Conditions

Concussion, Mild
Mild Traumatic Brain Injury (mTBI)
Psychological Health

Explore related trials

Concussion

Where it's being run

2 sites across 2 states
Pennsylvania1
Texas1

Study leadership

  • Anthony Kontos, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Anthony Kontos, PhD
[email protected]
814-615-2163
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Generalized Anxiety Disorder (GAD-7)Baseline, 4-week, 3-month, 6-month study visits

    The GAD-7 is a seven item self-reported questionnaire that measures severity of symptoms regarding anxiety. Responses are 0 = not at all, 1 = several days, 2= more than half the days, and 3 = nearly every day. Higher scores are indicative of higher anxiety (0-4 = minimal anxiety, 5-9= mild anxiety, 10-14 =moderate anxiety, 15-21 = severe anxiety.

  • Neurobehavioral Symptom Inventory (NSI)Baseline, 4-week, 3-month, 6-month study visits

    The NSI is a 22-item symptoms scale in which participants rate the severity of symptoms on a 5-point scale (0=none, 1= mild, 2=moderate, 3=severe, 4=very severe) Scores range from 0 to 60. The NSI takes approximately 5-10 minutes to administer. NSI total score changes will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.