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

Trial Summary

What is the purpose of this trial?

This randomized waitlist control trial will evaluate the effects of a psychoeducational intervention called Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) to decrease caregiver strain (primary outcome) and improve caregiver self-efficacy, anxiety, depression, and health care frustrations (secondary outcomes). This study will modify and adapt an award-winning caregiver intervention, Resources for Enhancing All Caregivers Health in the Department of Veterans Affairs (REACH VA), to support the needs of Caregivers of Veterans and Service Members with TBI.

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 data supports the effectiveness of the treatment REACH TBI, REACH VA, Resources for Enhancing All Caregivers Health - Traumatic Brain Injury?

The study titled 'A Randomized Controlled Pilot Study of a Manualized Intervention for Caregivers of Patients With Traumatic Brain Injury in Inpatient Rehabilitation' suggests that structured interventions can help address the needs of caregivers of people with traumatic brain injury, potentially improving their well-being. ^{1 2 3 4 5}

What makes the REACH TBI treatment unique for caregivers of individuals with traumatic brain injury?

The REACH TBI treatment is unique because it focuses specifically on supporting caregivers of individuals with traumatic brain injury, addressing their psychological and social needs, which are often overlooked in other treatments. It emphasizes education, encouragement, and social problem-solving to improve caregiver resilience and reduce stress. ^{1 4 5 6 7}

Eligibility Criteria

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

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

Participant has auditory impairment that would make telephone use difficult

I do not own a telephone.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Caregiver resilience following traumatic brain injury: Findings at six months postinjury. [2023]

2. United States 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). [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Characteristics and Health Outcomes of Post-9/11 Caregivers of US Service Members and Veterans Following Traumatic Brain Injury. [2019]

4. United States 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the Brain Injury Family Intervention: Impact on Family Members. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

The invisible side of war: families caring for US service members with traumatic brain injuries and polytrauma. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Caregiver's Burden of the Patients With Traumatic Brain Injury. [2020]