Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury

NCT03739450 | Completed Results

• 2 other identifiers: STU 042018-05290DPTB0013-01-00
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Care Partners of Patients With Traumatic Brain Injury (TBI)

Outcome Measures

Primary Outcomes (2)

• Changes From T2 to T3 in the Patient Health Questionnaire (PHQ9)

  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)

  1-month (T2), 6-month (T3) post-discharge between both arms

• Changes T2 to T3 in the Zarit Burden Interview (ZBI) Group/Arm Differences at T2 in the ZBI

  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)

  1 month (T2) and 6 month (T3) post-discharge between both arms

Secondary Outcomes (2)

• Alcohol Use Disorders Identification Test (AUDIT)

  Baseline and 6-month post-discharge

• Brief Coping Orientation to Problems Experienced

  1-month (T2) and 6-month (T3) post-discharge

Study Arms (2)

Problem Solving Training + Education

EXPERIMENTAL

Participants in this arm will receive the TBI-specific education intervention and the Problem Solving Training (PST) intervention.

Behavioral: Problem Solving Training (PST); Behavioral: Education

Education

ACTIVE COMPARATOR

Participants in this arm will only receive the TBI-specific education intervention.

Behavioral: Education

Interventions

Problem Solving Training (PST) BEHAVIORAL

The PST intervention consists of six sessions that will follow a structured format based on the PST manual. In these sessions, the interventionist will first provide the TBI-specific education, introduce the participant to the PST steps, then help the care partner generate and select a problem to address first. Interventionist will facilitate the care partner's use of the ABCDEF steps of PST to develop a specific action plan to solve the problem. As problems are attempted or solved, the care partner will learn how to perform the steps on his/her own, thus acquiring self-management problem solving skills that will be applicable to future problems. The final session will include a review and generalization of the PST steps and progress made.

Problem Solving Training + Education

Education BEHAVIORAL

Participants will receive TBI-specific education alone through a workbook. It consists of educational modules for self-study, common sequelae of TBI, issues encountered by care partners, work and school concerns for those with TBI, and on navigating the rehab system and accessing resources. The modules consist of a brief introduction, key definitions, examples, resources, and a summary. Some chapters also include self-directed activities, such as worksheets or checklists. The investigators will provide a brief orientation to the workbook and include open-ended questions about the participants' need for clarification or questions of the education material. The last session will consist of an open discussion about expected problems that may arise post-discharge.

Education; Problem Solving Training + Education

Eligibility Criteria

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

You may qualify if:

• Identified as care partner of an individual with TBI admitted to inpatient rehabilitation. A care partner is defined as an individual (spouse, partner, family member, friends, or neighbor) involved in assisting the patient with activities of daily living and/or medical tasks or responsible in any way for the patient's well-being after discharge from inpatient rehabilitation.
• \>1-year relationship
• Ability to communicate in English.
• \>18 years old
• Capacity to self-consent

You may not qualify if:

• Dispute over care partner's role in the care of patient.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Baylor Health Care System: collaborator
• Kessler Institute for Rehabilitation: collaborator
• Hackensack Meridian Health: collaborator

Study Sites (4)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

JFK Johnson Rehabilitation Institute

Edison, New Jersey, 08820, United States

Location

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (26)

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  PMID: 30885800 DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

In reviewing the original submitted protocol, the time frame of interest for a change in the primary and secondary outcome measures was 1 month to 6 months (all post-intervention), given the timing of the intervention delivery relative to onset of the care recipient's condition and the nature of the outcomes. This was a feasibility study to inform a future efficacy trial; decisions about timing, measures, and recruitment were the primary goals.

Results Point of Contact

• Title: Dr. Shannon Juengst
• Organization: UT Southwestern Medical Center

Shannon.Juengst@UTSouthwestern.edu

8328480674

Study Officials

• Shannon Juengst, PhD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will be ensured by allocating to group assignment after baseline assessment is complete, having different staff performing assessments vs delivering the intervention, scheduling meetings with assessors and interventionists separately, and instructing participants to not discuss the intervention with the person calling to complete follow-up assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants are randomized and allocated after baseline assessment to PST + Education or Education only via stratified, blocked randomization. Randomization is stratified by participating center and then based on whether a single care partner or multiple care partners are participating for the same patient by participating TBIMS Center. The investigators used a block size of four to ensure equal numbers across groups and to account for potentially small numbers of participants at any given TBIMS Center. Randomization is computer-generated and maintained by the TBI Model Systems National and Statistical Data Center. Allocation assignments for each center are distributed to the site PI and maintained in a password-protected electronic file. Outcome assessors are blinded to intervention allocation.

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 13, 2018
• Study Start: November 20, 2018
• Primary Completion: October 22, 2022
• Study Completion: October 22, 2022
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The research module data will remain under the control of the lead project team for one year after completion of data collection of the project. This will allow ample time for analyses and preparation of planned manuscripts. After the one-year period, any of the centers may request the data for additional analysis and dissemination. See SOP 6b for more details on internal procedures.
• Access Criteria: Both internal and external entities may request IPD through two separate procedures. Internal Use: Participating site in the TBI Model Systems may reference SOP 602b for further procedures. External Use: All staff, students, and other related personnel not involved in the NIDILRR-funded TBI Model Systems Centers or Follow-up Centers who wish to use data from the TBI Model Systems National Database or Modules may request access to the data set by completing a Data Request and Use Agreement Form available for download at www.tbindsc.org The Data Request and Use Agreement Form, once complete, can be emailed or faxed to the Project Director of the TBI Model Systems National Data and Statistical Center (see www.tbindsc.org and go to contacts). Reference: SOP 602d

Locations

US (4)