Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT06819904
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) — BEHAVIORAL
    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.
  • Usual Care Vestibular Rehabilitation — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 27, 2025
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE)
    The ACTIVE intervention group will receive Acceptance and Commitment Therapy (ACT) + targeted vestibular 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 ACTIVE sessions will last 90 minutes and will be divided between the vestibular rehabilitation portion (30 minutes) and the ACT portion (60 minutes). ACT component and therapy sessions 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 Vestibular Rehabilitation (VESTIB CONTROL)
    The VESTIB CONTROL group will receive standard of care evaluations and treatments involving a holistic multidisciplinary approach, which includes vestibular rehabilitation, but will exclude any ACT components. Because usual standard of care is individualized to the patient's unique functional deficits, treatments combined with vestibular rehabilitation may focus on any one or more of the following: neuro-optometry, neuropsychology, physical and occupational therapy, or speech and language pathology, or general mental health interventions such as instruction regarding stress reduction. Participants will attend 4 weekly in-person visits for vestibular rehab, as well as any other interventions provided to them by their treating clinician.

Primary Outcome Measure

Dizziness Handicap Inventory (DHI) [ Time Frame: Baseline, 4-week, 3-month, 6-month study visits ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Concussion Research LaboratoryPittsburghPennsylvania15213-4512
Cyndi Holland, MPH
[email protected]
412-904-1298
Eric Meyer, PhD (SUB_INVESTIGATOR)
Intrepid Spirit Center, Carl R. Darnall Army Medical CenterFort HoodTexas76544
Scot Engel, PsyD
[email protected]
254-287-7281
Stacey Young-McCaughan, PhD
[email protected]
Alan Peterson, PhD (SUB_INVESTIGATOR)

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By research site
University of Pittsburgh Concussion Research Laboratory· Pittsburgh, PAIntrepid Spirit Center, Carl R. Darnall Army Medical Center· Fort Hood, TX

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