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

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 11, 2025
Start date
Feb 27, 2025
Status verified
Jun 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 Rehabilitation (ACT)
    The ACT intervention group will receive Acceptance and Commitment Therapy (ACT) + usual care 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 ACT sessions will last 60 minutes each and 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 Rehabilitation (CONTROL)
    The CONTROL group will receive standard of care evaluations and treatments involving a holistic multidisciplinary approach, but will exclude any ACT components. 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 such as instruction regarding stress reduction. The usual care intervention will be coordinated by a primary treating clinician and additional specialty care providers as indicated by the participant's evaluation, individualized patient goals, and concomitant treatments.

Primary Outcome Measure

Generalized Anxiety Disorder (GAD-7) [ 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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