Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03211884 |
| Other study ID # |
W81XWH-16-1-0690 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 13, 2017 |
| Est. completion date |
July 15, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Duquesne University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary aim of this study is to assess the efficacy of PST for positively impacting
distressed military family caregiver's depression and burden levels (secondary outcomes),
ultimately enhancing their mental health quality of life (QOL, primary outcome).
Description:
Background: Traumatic brain injury (TBI) is considered the "signature injury" of recent
conflicts in Iraq and Afghanistan, with 22% of returning troops experiencing a TBI. After
receiving acute and rehabilitative healthcare services, combat veterans with a TBI (active
Service Members and Veterans) are typically cared for at home, by their female (79%) parent
(62%, 32% spouses), and the majority (60%) of these caregivers receive little or no help from
others with their caregiving responsibilities. Not only is TBI a well-documented risk factor
for dementia of the Alzheimer's type (AD) later in life, noteworthy similarities exist
between the experiences of family caregivers of Veterans with TBI and caregivers of civilians
with AD. Symptoms of a TBI are very similar to AD and include cognitive impairment (deficits
in memory, language, attention, and/or planning), difficulty communicating, poor impulse
control, and poor emotion regulation. Both conditions necessitate adaptation to emotional and
behavioral changes in the injured family member, and personality changes may result in
relationship strain between the injured person and his or her family caregiver. Similar to
AD, symptoms of a TBI do not lessen over time, are often perceived as burdensome, and are
associated with negative mental health outcomes in their family caregivers. Similarly, both
AD and TBI family caregivers report additional stressors (e.g., continuous monitoring for
unpredictable behaviors and their consequences) when cohabitating with the impaired or
injured family member for an extended period of time.
Objective/Hypotheses: To improve the mental health of family caregivers of post-9/11 combat
veterans with a TBI, the proposed study is designed to evaluate the efficacy of an
evidence-based, short-term (9, 60-mintue session), solution-focused, self- management
intervention utilizing problem-solving therapy (PST) to lessen burden and depression levels,
and improve the quality of life (QOL) in co-residing family caregivers of combat veterans
with a TBI (military family caregivers). PST is based on the premise that real-life
problem-solving plays an important role as a mediator of the relationship between stressful
life events and negative mental health outcomes. When deficits in problem-solving lead to
ineffective coping attempts, under high levels of stress exposure, burden and depression is
likely to ensue. Building on our previous work with caregivers of civilians with mild
cognitive impairment (a proposed precursor for AD) and early-stage AD, it is hypothesized
that military family caregivers receiving PST training will endorse lower levels of
caregiving burden and depression, and improved mental health QOL, at each follow-up
assessment, than caregivers in the comparison (usual care) group.
Specific Aims: The primary aim of this study is to assess the efficacy of PST for positively
impacting distressed military family caregiver's burden, and depression levels, ultimately
enhancing their mental health QOL (primary outcomes). Data will also be collected to
characterize physical and social stressors for these caregivers such as illness that limits
the caregiver's activities, new household management and caregiving responsibilities,
satisfaction with social roles and activities, lifestyle constraints, the quality of the
marital relationship, perceived social support, and demographic factors. A secondary aim of
the proposed study is to determine which of a series of key caregiver sociodemographic
factors moderate PST- intervention efficacy for caregiving burden and mental health QOL
outcomes.
Study Design: A randomized controlled trail design (intention-to-treat model) will be used to
evaluate the effects of an individualized PST-based intervention on burden, mental health,
and well-being outcomes in family caregivers of combat veterans with a TBI. We expect to
enroll and randomize 100 family caregivers of Veterans with a TBI from the Joint Forces
Explosive Ordnance Disposal (the disarming and disposal of bombs) Warrior Foundation and
Boulder Crest Retreat for Wounded Warriors family caregiver websites. Caregivers assigned to
the PST group will receive nine PST training sessions (each approximately 60 minutes)
delivered face-to-face every two weeks (to allow time for problem solving efforts and
scheduling conflicts) using study-specific webcams (part of the Study Welcome Kit). Software
will be utilized that permits recording and saving of intervention sessions for review (to
ensure treatment fidelity over time). Outcomes will be collected through the Internet (to
enhance the study's sustainability and scalability) and measured baseline, and at 1-, 3-, 6-,
and 12-mos. post-intervention.
Study Relevance: Since family caregivers constitute the largest group of adult care providers
in the United States and the market value of family caregiving exceeds that spent on formal
health and nursing home care, the mental health and well-being of family caregivers of
Veterans with a TBI - and their subsequent ability to assist wounded Veterans at home (e.g.,
prevent institutionalization of injured/impaired Veterans) - is of paramount importance. If
the PST-based intervention reduces burden levels and improves mental health aspects of QOL in
military family caregivers, the data will be used to lay the foundation for offering PST-
based mental health services for distressed family caregivers of Veterans with a TBI through
the VA Program of Comprehensive Assistance for Family Caregivers.
