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RECRUITING
NCT06819904
NA

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

Summary

The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) with usual care vestibular rehabilitation (VESTIB CONTROL) in 250 individuals with mTBI-related vestibular 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.

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

Key Details

Gender

All

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-02-27

Completion Date

2027-08

Last Updated

2025-07-03

Healthy Volunteers

No

Interventions

BEHAVIORAL

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE)

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. They will also receive vestibular therapy that may include one or more exercises in the following groups: 1) gaze stability, 2) visual-vestibular habituation, and 3) balance/gait.

BEHAVIORAL

Usual Care Vestibular Rehabilitation

Participants will receive usual care at the discretion of each site's treating providers, excluding any components associated with ACT. They will also receive vestibular therapy that may include one or more exercises in the following groups: 1) gaze stability, 2) visual-vestibular habituation, and 3) balance/gait.

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