Clinical trial NCT03211884: Effects of PSTon Mental Health Outcomes in Caregivers of Post-9/11 Combat Veterans With a Traumatic Brain Injury
Official title: Evidence-Based Mental Health Services for Distressed Post-9/11 Military Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Military Family
Brain Injuries, Traumatic
Keywords: Problem solving therapy
Military family caregivers
Cognitive impariment
Traumatic brain injury
Lead sponsor: Duquesne University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Chatham University
name: University of Pittsburgh
First posted: 2017-07-07
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trail.
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: Screen positive for caregiving burden

Lives with a post-9/11 Veteran or Service Member with a combat-related traumatic brain injury

Communicates in English

No exclusion criteria

Primary outcomes:
measure: Change in Mental health quality of life (QOL)
timeFrame: Baseline, 1, 3, 6, & 12 months post-intervention
measure: Change in Subjective caregiver burden
timeFrame: Baseline, 1, 3, 6, & 12 months post-intervention
Secondary outcomes:
measure: Change in Depression Levels
timeFrame: Baseline, 1, 3, 6, & 12 months post-intervention
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Duquesne University
state: Pennsylvania
Study officials:
affiliation: Duquesne University
name: Linda Garand, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: