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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Military Family, Brain Injuries, Traumatic
- 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 group | Role | What they receive |
|---|---|---|
| Problem-solving therapy | Experimental | Couched 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 Care | No intervention | Usual 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.
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
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)
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.
- First posted7 Jul 2017
- Study start13 Jul 2017
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Military FamilyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Chatham University, University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Linda Garand, Ph.D., Principal investigator, Duquesne University
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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-Based Mental Health Services for Distressed Post-9/11 Military Family Caregivers
- ClinicalTrials.gov ID
- NCT03211884
- Acronym / sponsor ID
- W81XWH-16-1-0690
- Conditions
- Military Family, Brain Injuries, Traumatic
- Keywords
- Problem solving therapy, Military family caregivers, Cognitive impariment, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense, Chatham University, University of Pittsburgh
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical Trail.
| Arm | Type | Receives |
|---|---|---|
| Problem-solving therapy | Experimental | Behavioral: Problem-Solving ThearpyCouched 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. |
| Usual Care | No intervention | –Usual 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem-Solving ThearpyAlso: PSTThe 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. | Behavioural | Problem-solving therapy |
Primary outcome
Change in Mental health quality of life (QOL)
Time frame: Baseline, 1, 3, 6, & 12 months post-intervention
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).
Change in Subjective caregiver burden
Time frame: Baseline, 1, 3, 6, & 12 months post-intervention
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.
1 secondary outcome
Change in Depression Levels
Time frame: Baseline, 1, 3, 6, & 12 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Garand, Ph.D. principal investigator
Duquesne University
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.