Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury
CompletedNAResults postedLast updated 5 March 2025
What this trial tests
NA trial testing Problem Solving Training (PST) in Care Partners of Patients With Traumatic Brain Injury (TBI) in 94 participants. Completed in 22 October 2022.
18 and older, any sex, with Care Partners of Patients With Traumatic Brain Injury (TBI). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Changes From T2 to T3 in the Patient Health Questionnaire (PHQ9)Primary· 1-month (T2), 6-month (T3) post-discharge between both arms
The PHQ-9 assesses the frequency over the past two weeks of each of the nine symptoms of DSM-IV-TR that define a major depressive episode. Total scores range from 0-27, with established interpretative symptom cut-off scores of 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and \>20 (severe).(positive = improvement)
Group
Value
95% CI
Problem Solving Training + Education
2.9
± 4.8
Education
1.5
± 3.2
Changes T2 to T3 in the Zarit Burden Interview (ZBI) Group/Arm Differences at T2 in the ZBIPrimary· 1 month (T2) and 6 month (T3) post-discharge between both arms
The ZBI is a self-reported measure of perceived caregiver burden, including psychological health, well-being, social and family life, finances, and perceive control. There are multiple versions of the ZBI, but the investigators will use the 22-item version (each scored on a 5-pt Likert Scale), because it has been found to have good internal consistency reliability (α=.92) and established reference values for interpretation (mild: 2-20; mild to moderate: 21-40; moderate to severe:41-60; severe: 61-88). (positive = improvement)
Group
Value
95% CI
Problem Solving Training + Education
7.7
± 10.4
Education
2.6
± 10.0
Alcohol Use Disorders Identification Test (AUDIT)Secondary· Baseline and 6-month post-discharge
The AUDIT is a 10-item screening tool for alcohol use behaviors designed by the World Health Organization to screen for alcohol abuse.The AUDIT assesses consumption, drinking behaviors, and alcohol-related problems. Scores range from 0-30, with a score of \>8 indicating harmful alcohol use. Change scores were calculated from baseline to 6-month post-discharge.
Group
Value
95% CI
Problem Solving Training + Education
0.59
± 1.58
Education
1.14
± 2.38
Brief Coping Orientation to Problems ExperiencedSecondary· 1-month (T2) and 6-month (T3) post-discharge
The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The coping style of interest was Problem-Focused coping, with higher scores indicating more use of these kinds of coping strategies (higher scores are better; 8 items from the overall 28). Scores could range from 8 to 32. Differences scores were calculated for change from T2 to T3
Group
Value
95% CI
Problem Solving Training + Education
-1.00
± 4.12
Education
0.41
± 5.21
Sponsor's own description
Importance: The chronic consequences of TBI are established, but ongoing support for adults with TBI living in the community is limited. This puts undue burden on care partners, particularly during the transition from hospital to home. It often leads to adverse consequences among care partners, such as emotional distress and increased substance abuse. Currently, there are no evidence-based interventions for care partners of adults with TBI to prepare them for this role. Problem Solving Training (PST) is an evidence-based, self-management approach with demonstrated efficacy for care partners of individuals with disabilities, but it has not been delivered or evaluated during inpatient rehabilitation.
Aims: Aim 1): To assess the feasibility of providing PST to care partners of adults with TBI during the inpatient rehabilitation stay; Aim 2) To assess the efficacy of PST + education vs education alone for improving caregiver burden, depressive symptoms, and coping skills Method: The investigators will conduct a randomized control trial of PST + Education vs Education alone during the inpatient rehabilitation stay of individuals with TBI. The investigators will enroll 172 care partners and conduct baseline assessment, with follow-up assessment at 1 month and 6 months post-discharge. For Aim 1, the investigators will measure number of sessions of PST completed and care partner satisfaction. For Aim 2, the investigators will compare differences in PST+Educaion vs. Education alone in measures of caregiver burden, depressive symptoms, and coping skills at 1-month and 6-months post-discharge.
Conclusion: The investigators anticipate that care partners will be able to complete a minimum of 3 sessions during the inpatient rehabilitation stay and that PST + Education will be more effective than Education alone for reducing caregiver burden and depressive symptoms and improving positive coping among care partners. PST is an evidence-based, self-management approach with a strong theoretical foundation that has demonstrated efficacy for care partners of individuals with disabilities. Early work indicates that it is also effective for care partners of adults with TBI. However, there are no studies evaluating whether delivery of PST to care partners is feasible during inpatient rehabilitation. The proposed project builds upon this foundation of evidence to address this critical gap in the literature. It will provide evidence for effective ways to support and improve outcomes for care partners during the transition from hospital to home.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 5 March 2025
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