Acceptance and Commitment Therapy for Traumatic Brain Injury

Recruiting at 2 trial locations

Overseen By Courtney Perry, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Vestibular disorder, Neurological disorder, Cervical spine injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for individuals with mild traumatic brain injury (mTBI) who experience balance and dizziness issues. It compares Acceptance and Commitment Therapy combined with balance exercises (ACTIVE) to the usual care for these symptoms. This therapy helps participants manage their symptoms by focusing on values, goal setting, and mental flexibility. The trial may suit those who sustained a mild brain injury over a week ago and experience dizziness or balance problems. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment options for mTBI-related symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) is safe for individuals with mTBI-related vestibular symptoms?

Research has shown that Acceptance and Commitment Therapy (ACT) has been safely used in individuals with brain injuries and strokes. While ACT can be effective, further studies are needed to fully understand its safety for this group. The ACTIVE treatment combines ACT with exercises to help with balance and dizziness, aiming to assist those with mild traumatic brain injury (mTBI) who experience symptoms like dizziness or balance issues.

Generally, ACT is well-tolerated and carries a low risk of serious side effects. It helps individuals accept their thoughts and feelings while taking actions that align with their values. This therapy has been used in other areas without major safety concerns.

Although limited data exists on the exact combination used in ACTIVE, the individual components are known to be safe. Participants should consult their healthcare providers about any concerns or questions before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) because it combines psychological techniques with physical therapy to address traumatic brain injury (TBI) in a new way. Unlike standard vestibular rehabilitation, which focuses primarily on physical exercises like balance and coordination, ACTIVE includes Acceptance and Commitment Therapy (ACT) to help patients develop psychological flexibility. This approach involves values clarification, goal setting, and training in emotional acceptance, cognitive defusion, and present-moment awareness. By integrating mental health strategies into physical rehab, ACTIVE aims to help patients overcome mental obstacles and achieve values-driven goals, potentially leading to more comprehensive recovery outcomes for individuals with TBI.

What evidence suggests that Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) might be an effective treatment for mTBI-related vestibular symptoms?

Research has shown that Acceptance and Commitment Therapy (ACT) can reduce anxiety, depression, and stress in individuals with traumatic brain injuries. Several studies have found ACT effective for brain injuries such as mild traumatic brain injury (mTBI) and stroke. In this trial, participants in the ACTIVE intervention group will receive ACT combined with targeted vestibular rehabilitation exercises. ACT teaches skills like accepting emotions and staying focused on the present, helping individuals manage symptoms more effectively. When combined with exercises that improve balance and coordination, this approach aims to enhance both mental and physical recovery. This combination therapy specifically addresses the unique challenges faced by mTBI patients. Meanwhile, the VESTIB CONTROL group will receive usual care vestibular rehabilitation without the ACT components. ^{1 2 3 4 5}

Who Is on the Research Team?

Anthony Kontos, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals with mild traumatic brain injury (mTBI) who are experiencing vestibular symptoms, such as dizziness or balance problems. Participants must be treated at either the University of Pittsburgh Medical Center or the Intrepid Spirit Center in Texas.

Inclusion Criteria

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

My vision is normal or corrected to normal.

I have experienced symptoms like confusion, dizziness, or memory problems after a head injury.

Exclusion Criteria

Exercise-induced dizziness as determined by the Physical Therapist exam

I have trouble moving my neck due to an injury.

< 8 days following current mTBI as determined by self-report

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ACTIVE or VESTIB CONTROL interventions over 4 weeks, with weekly in-person sessions

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment at 4-week, 3-month, and 6-month intervals

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE)

Trial Overview The study compares two treatments: usual care vestibular rehabilitation and a new approach called Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE). Each treatment lasts four weeks, with assessments before, after, and at 3- and 6-month follow-ups.

How Is the Trial Designed?

Group I: Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) Experimental Treatment 1 Intervention

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.

Group II: Usual Care Vestibular Rehabilitation (VESTIB CONTROL) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Acceptance and Commitment Therapy (ACT-Adjust) showed promise in reducing psychological distress, specifically depression and stress, in individuals with severe traumatic brain injury (TBI) compared to an active control group, with significant results observed immediately post-treatment.

While the initial reductions in depression and stress were clinically significant, these benefits did not persist at the one-month follow-up, indicating that additional sessions may be necessary to maintain treatment effects and warranting further research in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can acceptance and commitment therapy facilitate psychological adjustment after a severe traumatic brain injury? A pilot randomized controlled trial. Whiting, D., Deane, F., McLeod, H., et al.[2021]

Acceptance and commitment therapy combined with vestibular rehabilitation was successfully implemented in 27 patients with persistent postural-perceptual dizziness, showing significant improvement in dizziness scores 6 months post-treatment (P < .001).

40.7% of patients achieved remission and 59.3% showed a significant treatment response, indicating that this therapy may provide long-term benefits for managing dizziness symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy combined with vestibular rehabilitation for persistent postural-perceptual dizziness: A pilot study. Kuwabara, J., Kondo, M., Kabaya, K., et al.[2021]

Acceptance and Commitment Therapy (ACT) may effectively reduce anxiety and depressive symptoms in patients with acquired brain injury (ABI), as shown by medium to large decreases in symptoms for three out of four participants in a year-long study.

Participants also reported improvements in stress and quality of life, although there were no significant changes in psychological flexibility or social participation, indicating that while ACT shows promise, further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for individuals with depressive and anxiety symptoms following acquired brain injury: A non-concurrent multiple baseline design across four cases. Rauwenhoff, JCC., Bol, Y., Peeters, F., et al.[2023]

A scoping review of 54 studies on Acceptance and Commitment Therapy (ACT) in adults with neurological conditions identified 136 measurement tools, highlighting the need for standardized measures in this area.

The most commonly used process measure was the Acceptance and Action Questionnaire, while health-related outcomes focused on quality of life, anxiety, and depression, indicating key areas of concern for patients with conditions like multiple sclerosis and stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review to identify process and outcome measures used in acceptance and commitment therapy research, with adults with acquired neurological conditions. Foote, H., Bowen, A., Cotterill, S., et al.[2023]

Acceptance and Commitment Therapy (ACT) shows promising effectiveness in improving functionality and well-being for individuals with psychological disturbances or medical problems, including those with acquired brain injuries (ABI).

There is a growing body of evidence suggesting that ACT and mindfulness-based interventions could be beneficial in the rehabilitation of ABI patients, highlighting the need for further research to rigorously test their efficacy in helping these individuals lead meaningful lives despite their challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it time to act? The potential of acceptance and commitment therapy for psychological problems following acquired brain injury. Kangas, M., McDonald, S.[2021]

A randomized controlled trial involving 93 individuals with traumatic brain injury (TBI) showed that Acceptance and Commitment Therapy (ACT) significantly reduced psychological distress over eight weeks compared to a control group that received brief counseling.

The ACT group not only reported lower distress levels but also improved psychological flexibility, suggesting that ACT is an effective intervention for addressing psychological issues in TBI patients, especially when tailored to their cognitive needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of acceptance and commitment therapy for psychological distress among persons with traumatic brain injury. Sander, AM., Clark, AN., Arciniegas, DB., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06819904

Acceptance and Commitment Therapy Integrated ... The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Vestibular ...

2. trialx.com trialx.com/clinical-trials/listings/324045/acceptance-and-commitment-therapy-integrated-vestibular-rehabilitation-active-rct/

Acceptance and Commitment Therapy Integrated ... Overview. The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy ...

3. strongstar.org strongstar.org/research/strongstar/acceptance-and-commitment-therapy-integrated-vestibular-rehabilitation-active-for-mtbi-a-targeted-randomized-controlled-trial/

Acceptance and Commitment Therapy Integrated ... A combination therapy for vestibular rehabilitation and psychological health following a mild traumatic brain injury.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10291735/

Acceptance and commitment therapy for people with ... Furthermore, several studies showed that acceptance and commitment therapy can be effective for people with traumatic brain injury and stroke. However, more ...

5. withpower.com withpower.com/trial/acceptance-and-commitment-therapy-for-traumatic-brain-injury-27b5e

Acceptance and Commitment Therapy for Traumatic Brain ... Research shows that Acceptance and Commitment Therapy (ACT) can help reduce anxiety, depression, and stress in people with traumatic brain injuries. Studies ...