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

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ClinicalTrials.gov Identifier: NCT03211884
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : August 25, 2017
Sponsor:
Collaborators:
United States Department of Defense
Chatham University
University of Pittsburgh
Information provided by (Responsible Party):
Duquesne University

Brief Summary:
The primary aim of the proposed 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

Condition or disease Intervention/treatment Phase
Military Family Brain Injuries, Traumatic Other: Problem-solving therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Clinical Trail.
Masking: None (Open Label)
Masking Description: Self-administered on-line surveys which preclude the need for a masked outcomes assessor.
Primary Purpose: Treatment
Official Title: Evidence-Based Mental Health Services for Distressed Post-9/11 Military Family Caregivers
Actual Study Start Date : July 13, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Problem-solving therapy
PST 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 will receive 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 will keep a record of their problem-solving efforts between sessions and questions they have related to the application of PST. These records will be used as a basis for discussion during the intervention.
Other: Problem-solving therapy
PST 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 will receive 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 will keep a record of their problem-solving efforts between sessions and questions they have related to the application of PST. These records will be used as a basis for discussion during the intervention.

No Intervention: Usual Care
Potential participants will be told that by agreeing to be randomized to UC group, and completing the study surveys over 18 months, they will contribute to our knowledge about what it is like to provide care and assistance to a post-9/11 Veteran or Service Member with a TBI, what caregiver services they use, and to learn if education in problem solving improves mental health outcomes in these military family caregiver (compared to caregivers assigned to the UC group).



Primary Outcome Measures :
  1. Change in Mental health quality of life (QOL) [ Time Frame: Baseline, 1, 3, 6, & 12 months post-intervention ]
    Overall mental health quality of life (QOL) will be measured with the mental health component of the Medical Outcomes Survey (MOS), 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).

  2. Change in Depression symptom levels [ Time Frame: Baseline, 1, 3, 6, & 12 months post-intervention ]
    The Center for epidemiological Studies - Depression Scale (CES-D) 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.

  3. Change in Perceived caregiver burden [ Time Frame: Baseline, 1, 3, 6, & 12 months post-intervention ]
    Perceived caregiving burden will 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.

  4. Change in Caregiver burden associated with frequently occurring bothersome behaviors (exhibited by the care recipient) [ Time Frame: Baseline, 1, 3, 6, & 12 months post-intervention ]
    Frequently occurring and moderately to severely bothersome behaviors exhibited by the care recipient will be measured with the Revised Memory and Behavior Problem Checklist (RMBPC). The RMBPC evaluates the frequency of 40 possible behavioral problems exhibited by the care recipient over the past week, as well as the extent of the caregiver's reaction to such behaviors. Preliminary data suggests that this measure accurately identifies behavioral disturbances associated with dementia caregiver reactions to such behaviors. Reliability alphas of the RMBPC ranges from .84 to .91 when used in our pilot work. The original RMBPC format will be modified to include an open-ended question to determine if the care recipient exhibited bothersome and bothersome behaviors that were not covered in the measure.


Secondary Outcome Measures :
  1. Coping Resource - Problem Orientation [ Time Frame: Baseline, 1, 3, 6, & 12 months post-intervention ]
    Problem orientation will be assessed with the Social Problem Solving Inventory - Revised: Short Form (SPSI-R: S); which assesses two dimensions of problem solving orientation (positive and negative problem orientation) and three styles of problem solving. A positive problem orientation (PPO) is the extent to which an individual appraises a problem as solvable and believes in one's ability to solve problems successfully. In contrast, a negative problem orientation (NPO) reflects extent to which an individual appraises a problem as unsolvable or doubts one's ability to solve problems successfully. Cronbach's alpha was .60 for the PPO subscale and .73 for the NPO subscale in our preliminary work.


Other Outcome Measures:
  1. Physical Aspects of QOL - Overall [ Time Frame: Baseline, 1, 3, 6 & 12 months post-intervention ]
    Overall Physical Aspects of QOL will be assessed with the physical component of as measured by the SF-12v2. Both Mental Component Summary Scores (MCS) and Physical Component Summary Scores (PCS) were shown to have high internal consistency reliability (alpha > .80).

  2. Physical Aspects of QOL - Activity Limitations [ Time Frame: Baseline &12 months post-intervention ]
    Physical Aspects of QOL will also be assessed with one study-specific item in the sociodemographic questionnaire (are your activities limited by illness?)

  3. Physical Aspects of QOL - Caregiving Tasks [ Time Frame: Baseline, 6 months & 12 months post-intervention ]
    Physical Aspects of QOL will also be assessed with.a questionnaire about the number of new household and personal care responsibilities (Tasks) the caregiver has assumed since their loved one was diagnosed with a TBI. On the Tasks inventory, caregivers indicated which of 11 household (e.g., managing finances, shopping, making appointments) and personal management tasks (e.g., preparing meals, running errands) and which of 8 nursing-related tasks (e.g., helping with medications, help with mobility) they perform for their loved-one with a TBI.

  4. Social Aspects of QOL - Lifestyle Constraints [ Time Frame: Baseline, 6 months and 12 months post-intervention ]
    The Montgomery Objective Caregiver Burden Scale will be used to determine perceptions of lifestyle constraint related to caregiving responsibilities (e.g., time, privacy, money, and leisure activities). This scale demonstrated sound psychometric properties (Cronbach's alpha .91) when used this measure with new family caregivers of persons with mild cognitive deficits. In the current study, participants rate eight items concerning the degree to which aspects of their life were affected by their loved one's TBI (1 = little or no restriction; 5 = a large degree of restriction).

  5. Social Aspects of QOL - Quality of the Marital Relationship [ Time Frame: Baseline, 6 months & 12 months post-intervention ]
    The quality of the marital relationship will be evaluated using the Dyadic Adjustment Scale-Short Form (DAS-S). The DAS-S is a 20-item self-report measure of marital quality that yields a summary score, with higher scores indicating better marital quality. Cronbach's alpha in the subsample of married caregivers was .89 in the feasibility study sample.

  6. Social Aspects of QOL - Perceived Social Support [ Time Frame: Baseline, 6 months & 12 months post-intervention ]
    The Social Provision Scale (SPS) will be used to assess the caregiver's level of perceived social support. The SPS consists of 24 items, measuring 6 components of social support (Guidance, Reassurance of Worth, Social Integration, Attachment, Nurturance, and Reliable Alliance). A total perceived social support score is computed by summing the subscales. In the feasibility study, the SPS Cronbach's alpha for the total score was .93.

  7. Coping Resource - Perceived Self-Efficacy [ Time Frame: Baseline, 6 months & 12 months post-intervention ]
    Perceived self-efficacy will be measured with the Coping Self-Efficacy Scale (CSES). Exploratory and confirmatory factor analyses of the CSES revealed three factors: use problem-focused coping (α = .91), stop unpleasant emotions and thoughts (α = .91), and get support from friends and family (α = .80). Internal consistency and test-retest reliability are strong for all three factors.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Study inclusion criteria are that the participant:

  1. screens positive for caregiving burden,
  2. lives with a post-9/11 Veteran or Service Member with a diagnosis of a TBI,
  3. can communicate using the English language, and
  4. are 18 years or older.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211884


Contacts
Contact: Linda Garand, Ph.D. 412-396-6543 garandl@duq.edu
Contact: Elizabeth La Rue, Ph.D. 412-999-4812 laruee@duq.edu

Locations
United States, Pennsylvania
Duquesne University Recruiting
Pittsburgh, Pennsylvania, United States, 15282
Contact: Elizabeth La Rue, Ph.D.    412-999-4812    laruee@duq.edu   
Contact: Linda Garand, Ph.D.    412-396-9831    garandl@duq.edu   
Sponsors and Collaborators
Duquesne University
United States Department of Defense
Chatham University
University of Pittsburgh
Investigators
Principal Investigator: Linda Garand, Ph.D. Duquesne University

Additional Information:
Responsible Party: Duquesne University
ClinicalTrials.gov Identifier: NCT03211884     History of Changes
Other Study ID Numbers: W81XWH-16-1-0690
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duquesne University:
Problem solving therapy
Military family caregivers
Cognitive impariment
Traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries