RecruitingNot ApplicableNCT06819904

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted Randomized Controlled Trial


Sponsor

University of Pittsburgh

Enrollment

250 participants

Start Date

Feb 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) and a behavioral approach called Usual Care Vestibular Rehabilitation for people with concussion, mild, mild traumatic brain injury (mtbi), and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 49 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAcceptance 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.

BEHAVIORALUsual 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.


Locations(2)

University of Pittsburgh Concussion Research Laboratory

Pittsburgh, Pennsylvania, United States

Intrepid Spirit Center, Carl R. Darnall Army Medical Center

Fort Hood, Texas, United States

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NCT06819904


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