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

NCT03211884 | Completed DMC

• 1 other identifier: W81XWH-16-1-0690
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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).

Conditions

Military Family; Brain Injuries, Traumatic

Keywords

Problem solving therapy; Military family caregivers; Cognitive impariment; Traumatic brain injury

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

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

Secondary Outcomes (1)

• Change in Depression Levels

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

Study Arms (2)

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.

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).

Interventions

Problem-Solving Thearpy BEHAVIORAL

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.

Also known as: PST

Problem-solving therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Duquesne University: lead
• United States Department of Defense: collaborator
• Chatham University: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Linda Garand, Ph.D.

  Duquesne University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Self-administered on-line surveys which preclude the need for a masked outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trail.

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: July 7, 2017
• Study Start: July 13, 2017
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Follow-up data was collected until August 2020. Preliminary data analysis will be available by May 2021.

Locations

US (1)