Trial Outcomes & Findings for Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury (NCT NCT03739450)
NCT ID: NCT03739450
Last Updated: 2025-03-05
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
94 participants
Primary outcome timeframe
1-month (T2), 6-month (T3) post-discharge between both arms
Results posted on
2025-03-05
Participant Flow
Participant milestones
| Measure |
Problem Solving Training + Education
Participants in this arm will receive the TBI-specific education intervention and the Problem Solving Training (PST) intervention.
PST: This consists of six sessions that will follow a structured format based on the PST manual. 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, 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. Final session will include a review and generalization of the PST steps and progress made.
Education: Participants will receive TBI-specific education alone through a workbook. 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
Participants in this arm will only receive the TBI-specific education intervention.
Education: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
51
|
|
Overall Study
COMPLETED
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
14
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The 1 participant in the Education arm did not complete the measure
Baseline characteristics by cohort
| Measure |
Problem Solving Training + Education
n=37 Participants
Participants in this arm will receive the TBI-specific education intervention and the Problem Solving Training (PST) intervention.
Problem Solving Training (PST): 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.
Education: Participants will receive TBI-specific education alone through a workbook. 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
n=43 Participants
Participants in this arm will only receive the TBI-specific education intervention.
Education: 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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 12.0 • n=37 Participants
|
49.5 years
STANDARD_DEVIATION 15.7 • n=43 Participants
|
49.5 years
STANDARD_DEVIATION 14.0 • n=80 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=37 Participants
|
36 Participants
n=43 Participants
|
65 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=37 Participants
|
7 Participants
n=43 Participants
|
15 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=37 Participants
|
1 Participants
n=43 Participants
|
4 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=37 Participants
|
4 Participants
n=43 Participants
|
12 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=37 Participants
|
36 Participants
n=43 Participants
|
56 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=37 Participants
|
1 Participants
n=43 Participants
|
3 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=37 Participants
|
1 Participants
n=43 Participants
|
5 Participants
n=80 Participants
|
|
Depression (Patient Health Questionnaire)
|
8.6 units on a scale
STANDARD_DEVIATION 6.4 • n=37 Participants • The 1 participant in the Education arm did not complete the measure
|
7.4 units on a scale
STANDARD_DEVIATION 5.3 • n=42 Participants • The 1 participant in the Education arm did not complete the measure
|
7.96 units on a scale
STANDARD_DEVIATION 5.18 • n=79 Participants • The 1 participant in the Education arm did not complete the measure
|
PRIMARY outcome
Timeframe: 1-month (T2), 6-month (T3) post-discharge between both armsPopulation: The participants not analyzed here were lost to follow-up. These numbers do not match directly with the numbers in the participant flow since these are change scores. Therefore, participants had to have BOTH T2 and T3 data to be included in analysis.
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)
Outcome measures
| Measure |
Problem Solving Training + Education
n=11 Participants
Participants in this arm will receive the TBI-specific education intervention and the Problem Solving Training (PST) intervention.
PST: This consists of six sessions that will follow a structured format based on the PST manual. 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, 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. Final session will include a review and generalization of the PST steps and progress made.
Education: Participants will receive TBI-specific education alone through a workbook. 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
n=17 Participants
Participants in this arm will only receive the TBI-specific education intervention.
Education: 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.
|
|---|---|---|
|
Changes From T2 to T3 in the Patient Health Questionnaire (PHQ9)
|
2.9 change score on a scale
Standard Deviation 4.8
|
1.5 change score on a scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: 1 month (T2) and 6 month (T3) post-discharge between both armsPopulation: The participants not analyzed here were lost to follow-up.
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)
Outcome measures
| Measure |
Problem Solving Training + Education
n=11 Participants
Participants in this arm will receive the TBI-specific education intervention and the Problem Solving Training (PST) intervention.
PST: This consists of six sessions that will follow a structured format based on the PST manual. 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, 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. Final session will include a review and generalization of the PST steps and progress made.
Education: Participants will receive TBI-specific education alone through a workbook. 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
n=16 Participants
Participants in this arm will only receive the TBI-specific education intervention.
Education: 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.
|
|---|---|---|
|
Changes T2 to T3 in the Zarit Burden Interview (ZBI) Group/Arm Differences at T2 in the ZBI
|
7.7 change score on a scale
Standard Deviation 10.4
|
2.6 change score on a scale
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Baseline and 6-month post-dischargePopulation: Participants not included in analysis were lost to follow-up. These numbers do not directly align with numbers in the participant flow chart since analyses were planned for change scores, requiring data at BOTH time points.
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.
Outcome measures
| Measure |
Problem Solving Training + Education
n=17 Participants
Participants in this arm will receive the TBI-specific education intervention and the Problem Solving Training (PST) intervention.
PST: This consists of six sessions that will follow a structured format based on the PST manual. 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, 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. Final session will include a review and generalization of the PST steps and progress made.
Education: Participants will receive TBI-specific education alone through a workbook. 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
n=22 Participants
Participants in this arm will only receive the TBI-specific education intervention.
Education: 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.
|
|---|---|---|
|
Alcohol Use Disorders Identification Test (AUDIT)
|
0.59 change score on a scale
Standard Deviation 1.58
|
1.14 change score on a scale
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: 1-month (T2) and 6-month (T3) post-dischargePopulation: Includes all participants with outcome data for this measure at both T2 and T3 (necessary to calculate change score). Participants not included were lost to follow-up at either or both time points.
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
Outcome measures
| Measure |
Problem Solving Training + Education
n=11 Participants
Participants in this arm will receive the TBI-specific education intervention and the Problem Solving Training (PST) intervention.
PST: This consists of six sessions that will follow a structured format based on the PST manual. 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, 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. Final session will include a review and generalization of the PST steps and progress made.
Education: Participants will receive TBI-specific education alone through a workbook. 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
n=11 Participants
Participants in this arm will only receive the TBI-specific education intervention.
Education: 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.
|
|---|---|---|
|
Brief Coping Orientation to Problems Experienced
|
-1.00 change score on a scale
Standard Deviation 4.12
|
0.41 change score on a scale
Standard Deviation 5.21
|
Adverse Events
Problem Solving Training + Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place