REACH Intervention for Caregivers of Individuals with Traumatic Brain Injury

(REACH TBI Trial)

Overseen By Paul B Perrin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: No telephone, Schizophrenia, Auditory impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called REACH TBI (Resources for Enhancing All Caregivers Health - Traumatic Brain Injury) to determine its effectiveness in reducing stress for caregivers of individuals with traumatic brain injury (TBI). The program also aims to boost caregivers' confidence, improve their mood, and reduce frustrations with health care. Participants will either receive the program immediately or join a waitlist to receive it later. The trial seeks caregivers who have provided daily assistance for someone with a TBI for at least six months and attribute most of their caregiving to TBI-related issues. As an unphased trial, it offers caregivers the opportunity to access potentially helpful resources and support.

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 seems focused on a psychoeducational program for caregivers, so it's unlikely that medication changes are required.

What prior data suggests that the REACH TBI intervention is safe for caregivers?

Research shows that the REACH psychoeducational program, used in the REACH TBI intervention, is safe. Studies have found that this program reduces stress and depression in caregivers without causing harm. Reports of negative effects are absent, indicating it is generally well-tolerated. The similar REACH VA program has also successfully helped caregivers manage stress and frustration. Overall, existing evidence considers the REACH TBI intervention safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the REACH TBI intervention because it takes a unique approach to support caregivers of individuals with traumatic brain injury. Unlike traditional treatment options that often focus solely on the medical aspects of TBI, REACH TBI provides a psychoeducational intervention specifically designed to address the emotional and educational needs of caregivers. This intervention aims to equip caregivers with the knowledge and skills to better manage the challenges of caring for someone with a TBI, potentially improving outcomes for both the caregiver and the patient. By focusing on the caregivers' well-being and education, this method could offer a more comprehensive support system that is currently lacking in standard care practices.

What evidence suggests that the REACH TBI intervention is effective for reducing caregiver strain?

Research has shown that the REACH VA program, on which REACH TBI is based, effectively reduces depression, stress, and frustration for caregivers. Known for addressing many challenges caregivers face, this program offers a personalized, 6-session telehealth approach that has successfully supported them. In this trial, participants in the REACH TBI arm will receive this intervention, which is expected to similarly help caregivers of people with traumatic brain injuries by reducing stress and improving overall well-being. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for primary caregivers of Veterans/Service Members (V/SM) who have been caring for someone with a Traumatic Brain Injury (TBI) for at least 6 months. Caregivers should provide daily help due to TBI-related issues and feel the burden of care. Those without phone access, with major mental illnesses or hearing issues that hinder phone use, or whose caregiving mainly involves non-TBI conditions cannot participate.

Inclusion Criteria

You must have a high score (8 or higher) on the Zarit Burden Inventory-4.

I need daily help due to issues from a brain injury.

I believe over half of my caregiving duties are for someone with a brain injury.

Exclusion Criteria

I do not own a telephone.

You have been diagnosed with schizophrenia or another serious mental illness.

Participant has auditory impairment that would make telephone use difficult

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist Control

Participants in the waitlist control group will receive the REACH TBI psychoeducational intervention after a waiting period

3 months

Regular check-ins (virtual)

REACH TBI Intervention

Participants receive the REACH TBI psychoeducational intervention to decrease caregiver strain and improve self-efficacy, anxiety, depression, and health care frustrations

3 months

Regular sessions (virtual)

Follow-up

Participants are monitored for caregiver strain, self-efficacy, anxiety, depression, and health care frustrations after the intervention

6 months

Follow-up assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• REACH TBI

Trial Overview The study tests REACH TBI, an educational program designed to reduce caregiver strain and improve their confidence, mood, and ability to handle health care frustrations. Participants will be randomly assigned either immediate entry into the program or placed on a waitlist as part of the control group.

How Is the Trial Designed?

Group I: REACH TBI Experimental Treatment 1 Intervention

Participants will receive the REACH TBI psychoeducational intervention.

Group II: Waitlist Control Active Control 1 Intervention

Participants will receive the REACH TBI psychoeducational intervention.

REACH TBI is already approved in United States for the following indications:

Approved in United States as REACH VA for:

• Support for caregivers of Veterans with Alzheimer's disease, spinal cord injuries, traumatic brain injuries, Multiple Sclerosis, Post Traumatic Stress Disorder, and Amyotrophic lateral sclerosis

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

University of Tennessee

Collaborator

Trials

202

Recruited

146,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+

James A. Haley Veterans Administration Hospital

Collaborator

Trials

21

Recruited

13,200+

Published Research Related to This Trial

A survey of 564 caregivers for US service members with traumatic brain injury revealed that caregiving is predominantly undertaken by women, mainly parents or spouses, highlighting the significant role of family in post-injury support.

After an average of 4 years post-injury, many patients still require substantial assistance, with 22% needing help with daily activities and nearly 25% of caregivers providing over 40 hours of care per week, indicating a need for additional resources to support these caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The invisible side of war: families caring for US service members with traumatic brain injuries and polytrauma. Griffin, JM., Friedemann-Sánchez, G., Jensen, AC., et al.[2022]

Caregivers of individuals with moderate-to-severe traumatic brain injury reported resilience levels comparable to community norms, indicating that they can maintain psychological strength despite their caregiving challenges.

The study found that meeting emotional support needs significantly contributes to caregiver resilience, suggesting that enhancing emotional support networks could improve outcomes for both caregivers and individuals with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver resilience following traumatic brain injury: Findings at six months postinjury. Marwitz, JH., Perera, RA., Klyce, DW., et al.[2023]

The Brain Injury Family Intervention significantly improved caregiver outcomes, including increased satisfaction with services and reduced caregiver burden, after five 2-hour sessions with 108 families participating in the study.

The benefits of the intervention were observed up to 3 months post-treatment, indicating its effectiveness in addressing the needs of family caregivers after acquired brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Brain Injury Family Intervention: Impact on Family Members. Kreutzer, JS., Marwitz, JH., Sima, AP., et al.[2015]

Caregivers of patients with moderate-to-severe traumatic brain injury (TBI) showed significant improvements in meeting their emotional support needs and knowledge about brain injury after a 5-session intervention, compared to a control group.

However, the benefits of the intervention did not last at the 3-month follow-up, suggesting that caregivers may need ongoing support to maintain these improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Pilot Study of a Manualized Intervention for Caregivers of Patients With Traumatic Brain Injury in Inpatient Rehabilitation. Niemeier, JP., Kreutzer, JS., Marwitz, JH., et al.[2020]

Caregivers of traumatic brain injury (TBI) patients, especially spouses and females, experience significant psychological and health issues, highlighting the need for better support and education for these caregivers before patient discharge.

The D'Zurilla and Nezu social problem-solving model was identified as the most beneficial therapeutic intervention for caregivers, suggesting that structured support and counseling can help alleviate caregiver stress and improve family dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver's Burden of the Patients With Traumatic Brain Injury. Qadeer, A., Khalid, U., Amin, M., et al.[2020]

The study involved 278 caregivers of service members and veterans with traumatic brain injuries, primarily focusing on those with mild TBI and comorbid PTSD/depression, highlighting the significant caregiving burden they face, often exceeding 40 hours per week.

Caregivers providing high levels of support reported poorer physical and mental health outcomes, indicating that the demands of caregiving can negatively impact their well-being and financial stability, emphasizing the need for better support systems for these caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Health Outcomes of Post-9/11 Caregivers of US Service Members and Veterans Following Traumatic Brain Injury. Brickell, TA., French, LM., Lippa, SM., et al.[2019]

The TBI-CareQOL measurement system, which includes 26 item banks for assessing health-related quality of life in caregivers of individuals with traumatic brain injury, has demonstrated strong reliability and validity based on a study of 385 caregivers.

The measures within TBI-CareQOL showed excellent internal consistency and stability, making them suitable for standardized assessments of caregiver quality of life in both civilian and service member populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and validity data to support the clinical utility of the Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL). Carlozzi, NE., Boileau, NR., Kallen, MA., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06111794

The REACH Intervention for Caregivers of Veterans and ... This study will modify and adapt an award-winning caregiver intervention, Resources for Enhancing All Caregivers Health in the Department of Veterans Affairs ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11362706/

Protocol for the REACH Intervention for Caregivers of ... This study will adapt and test an evidence-based, personalized, 6-session telehealth caregiver intervention, “Resources for Enhancing All Caregivers' Health” ( ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39145996/

Protocol for the REACH Intervention for Caregivers of ... This study will adapt and test an evidence-based, personalized, 6-session telehealth caregiver intervention, "Resources for Enhancing All Caregivers' Health" ( ...

4. caregiver.va.gov caregiver.va.gov/reach_va_program.asp

Resources for Enhancing All Caregivers Health (REACH ... The REACH VA Program has been shown to decrease caregiver depression, burden, and frustrations, and reduce the number of challenging problems reported.

5. psycnet.apa.org psycnet.apa.org/record/2026-45730-001

Reducing burden and anxiety for caregivers of veterans with ... This study developed and tested Resources for Enhancing All Caregivers' Health (REACH) Hope, which provides caregivers with one-on-one ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06111794/the-reach-intervention-for-caregivers-of-veterans-and-service-members-with-tbi?q=traumatic%20brain%20injury

The REACH Intervention for Caregivers of Veterans and ... This randomized waitlist control trial will evaluate the effects of a psychoeducational intervention called Resources for Enhancing All ...

7. centreforevidence.org centreforevidence.org/article/20250731-reducing-burden-and-anxiety-for-caregivers-of-veterans-with-traumatic-brain-injury-and-dementia-randomized-controlled-trial-of-the-resources-for-enhancing-all-caregivers-health

Reducing burden and anxiety for caregivers of Veterans with ... Conclusion: This is the first clinical trial to evaluate the efficacy of a telehealth intervention for caregivers of veterans with both TBI and dementia. REACH ...