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The REACH Intervention for Caregivers of Veterans and Service Members With TBI (REACH TBI)

University of Virginia logo

University of Virginia

Status

Enrolling

Conditions

Traumatic Brain Injury
Caregiver

Treatments

Other: REACH TBI

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT06111794
CDMRP-TP220091

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

To be eligible for the study, the participant must:

  • identify as a primary caregiver for a V/SM who sustained a TBI at least 6 months prior;
  • identify as a primary caregiver who has provided care for a V/SM with TBI for at least 6 months;
  • provide some level of daily supervision or assistance with either a physical, cognitive, or behavioral issue they think is likely related to TBI;
  • believe that at least half of their caregiving responsibilities are likely related to TBI rather than another health condition(s); and
  • endorse a score of at least high burden (a score of 8 or higher) on the Zarit Burden Inventory-4.

Exclusion criteria

  • no telephone;
  • current diagnosis of schizophrenia or other major mental illness;
  • auditory impairment that would make telephone use difficult; or
  • the caregiver believes that more than half of their caregiving for the V/SM is for issues related to another health condition(s) rather than TBI.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

160 participants in 2 patient groups

REACH TBI
Experimental group
Description:
Participants will receive the REACH TBI psychoeducational intervention.
Treatment:
Other: REACH TBI
Waitlist Control
Active Comparator group
Description:
Participants will receive the REACH TBI psychoeducational intervention.
Treatment:
Other: REACH TBI

Trial contacts and locations

1

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Central trial contact

Paul B Perrin, PhD

Data sourced from clinicaltrials.gov

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