Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

Launched by UNIVERSITY OF PITTSBURGH · Feb 4, 2025

Keywords

ClinConnect Summary

The ACTIVE trial is a research study looking at two different types of therapy for people who have experienced mild traumatic brain injuries (mTBI) and are experiencing problems with balance or dizziness, known as vestibular symptoms. The study aims to see if a new approach called Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) is more effective than standard vestibular rehabilitation treatment. This trial is taking place at two sites: the University of Pittsburgh Medical Center and the Intrepid Spirit Center in Texas, and they are looking for 250 participants aged 18 to 49 who have had an mTBI diagnosed by a healthcare professional.

If you decide to participate, you will receive treatment once a week for four weeks, either through the new ACTIVE therapy or the usual care. Before starting the treatment and again after four weeks, as well as three and six months later, you will undergo assessments to see how well the treatment is working. To be eligible, you should not have had previous serious head injuries or certain other medical conditions, and you should be experiencing symptoms related to your recent mTBI. This trial is a great opportunity to help researchers understand better ways to support recovery from mTBI-related symptoms.

Gender

ALL

Eligibility criteria

• 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.
• • Reported or observed signs of mTBI including loss of consciousness, amnesia, disorientation/confusion, dizziness, imbalance, memory problems, vomiting at the time of injury as determined by self-report.
• • Positive for mTBI-related vestibular symptoms and/or impairments per a concussion common data elements (CDE) assessment. Participants must demonstrate a positive finding in at least one of the following tests: DVAT (\>2 lines lost), DNRS (\>2/10 score), VVAS (\>0 on 2 or more items), VOMS (\>2 score on VOR or VMS), mBESS (\> 9 total errors), and CP-Screen (avg vestibular factor score \>/= 2 or single item = 3 severity)
• Exclusion Criteria:
• • History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction) as determined by patient self-report and/or by Physical Therapist exam.
• • Exercise-induced dizziness as determined by the Physical Therapist exam.
• • 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.