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AzTrials

Military FamilyNCT03211884

Effects of PSTon Mental Health Outcomes in Caregivers of Post-9/11 Combat Veterans With a Traumatic Brain Injury

A study testing Problem-Solving Thearpy in people with Military Family and Brain Injuries, Traumatic, run by Duquesne University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Military Family, Brain Injuries, Traumatic
What is being tested?
Problem-Solving Thearpy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
1 siteUnited States
Study dates
13 Jul 2017to 15 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duquesne University

    Pittsburgh, Pennsylvania, 15282

Other trials in United States

About this study

Official title: Evidence-Based Mental Health Services for Distressed Post-9/11 Military Family Caregivers

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).

Read the 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.

Being tested
Problem-Solving Thearpy
Keywords
Problem solving therapy, Military family caregivers, Cognitive impariment, Traumatic brain injury
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Problem-Solving ThearpyBehavioural

    Also called PST

    The problem-solving therapy (PST)-based intervention consists of nine, 60-90 minute educational sessions conducted face-to-face via the Internet (through video conferencing software) approximately 2 weeks apart. After attending a preliminary 15 minute "meet \& greet" session, participants received written and verbal education about solving everyday problems. Together, the participant and interventionist complete the 7-steps to solve at least one problem together before ending the training. Participants keep a record of their problem-solving efforts between sessions and questions they had related to the application of PST. These records were used as a basis for discussion during the PST training sessions.

Study groups in NCT03211884
Study groupRoleWhat they receive
Problem-solving therapyExperimentalCouched within Bandura's social-cognitive theory, self-management refers to the process by which individuals accept responsibility for and take action to change their behaviors, obtain knowledge related to their situation (e.g., behavioral manifestations of a TBI) through increased awareness and use of effective personal resources (e.g., skill in every-day problem-solving). This ultimately enhances the caregivers' confidence that they can cope with caregiving and behavior-related stressors in the care recipient.
Receives: Behavioral: Problem-Solving Thearpy
Usual CareNo interventionUsual care was defined as various military caregiver organizations, support groups and services available to all family caregivers of combat Veterans (e.g., Military OneSource; Operation We Are Here; Veterans Administration Program of Comprehensive Assistance for Family Caregivers; American Red Cross Military and Veteran Caregiver Network; Project New Hope; Wounded Veteran Family Care; Women for Wounded Warriors).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mental health quality of life (QOL)

    Mental health quality of life (QOL) is measured with the mental health component of the Medical Outcomes Survey (MOS) Health Survey Short Form-12 Version 2 (SF-12v2). MOS-SF-12V2 is a multipurpose survey of health related quality of life (both physical and mental) and a practical tool for directly linking norms from large population surveys with the results from more focused RCTs. Both Mental Component Summary Scores (MCS) and Physical Component Summary Scores (PCS) were shown to have high internal consistency reliability (alpha > .80).

    Measured: Baseline, 1, 3, 6, & 12 months post-intervention

  2. Change in Subjective caregiver burden

    Caregiving burden (worry, exhaustion) is measured with the Montgomery's Subjective Burden Scale (SBS). The SBS includes a series of 13 questions to establish how the caregiver feels about caring for their family member with dementia. The SBS demonstrated sound psychometric properties in the feasibility study (Cronbach's alpha = .95) and preliminary data shows variability in responses for the target population.

    Measured: Baseline, 1, 3, 6, & 12 months post-intervention

Secondary outcomes (1)
  1. Change in Depression Levels

    Depression levels are measured with the Center for epidemiological Studies - Depression Scale (CES-D, Revised) is composed of 20 items, each response corresponds to the frequency of the symptom in the preceding week, higher score indicate more severe depressive symptoms. A cutoff score of 16 or greater is indicative of individuals at high risk for clinical depression. The CES-D demonstrated high internal reliability (Cronbach's alpha = .91) in our feasibility study.

    Measured: Baseline, 1, 3, 6, & 12 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2017
  2. Study start13 Jul 2017
  3. Primary completion15 Jul 2020
  4. Study completion15 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Clinical Trail.
Masking
None (open label)
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03211884
Sponsor's protocol ID
W81XWH-16-1-0690
Status last verified
Mar 2021
First submitted
7 Jun 2017
Last updated
24 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data generated from the study will be made widely available, while safeguarding the privacy of participants and protecting confidential and proprietary data and third-party intellectual property. In line with the Congressionally Directed Medical Research Programs (CDMRP) policy, all unique data and final research data generated will be made available to the research community and to the public at large. Along with the data, documentation will be provided about the methodology and procedures used to collect the data, details about codes, definitions of variables, variable field locations, frequencies, and any other unique background information. The PI will share data via external storage media after the requester has completed a data-sharing agreement to impose appropriate limitations on the user.

Questions about this trial

What is this clinical trial studying?

A study testing Problem-Solving Thearpy in people with Military Family and Brain Injuries, Traumatic, run by Duquesne University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mental health quality of life (QOL) (time frame: Baseline, 1, 3, 6, & 12 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.

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