Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury
Public ClinicalTrials.gov record NCT03739450. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03739450
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 94 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 19, 2018
- Primary completion
- Oct 21, 2022
- Completion
- Oct 21, 2022
- Last update posted
- Mar 4, 2025
2018 – 2022
United States locations
- U.S. sites
- 4
- U.S. states
- 2
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kessler Foundation | East Hanover | New Jersey | 07936 | — |
| JFK Johnson Rehabilitation Institute | Edison | New Jersey | 08820 | — |
| Baylor Scott & White Institute for Rehabilitation | Dallas | Texas | 75246 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03739450, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 4, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03739450 live on ClinicalTrials.gov.