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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| Agnes Marshall Walker Foundation | UNKNOWN |
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The purpose of this feasibility study is to determine whether it is practical and helpful to provide problem-solving therapy to stroke survivors and their spouses/partners (caregivers) together. It will also compare the experiences of participants who receive problem-solving therapy to those who receive stroke-related health education.
Many stroke survivors and caregivers report feeling sad or blue at some point after the stroke. These feelings can impact quality of life. Encountering problems is a part of daily life. These problems can be big or small, but sometimes they can pile up and feel overwhelming, contributing to feelings of sadness. Problem-solving therapy is a tool that teaches structured ways to address current problems or challenges in your life.
Participants who are assigned to receive problem-solving therapy will work with a research team member for six, one-hour sessions. During each session, participants will identify a problem (big or small) and create a plan to work on that problem.
Participants who are assigned to receive stroke-related health education will work with a research team member who will teach them about various topics related to stroke over six, one-hour sessions. Each session will cover information about a different topic related to stroke.
Outcomes data will be collected at approximately 4 weeks, 8 weeks, and 13 weeks from baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Problem-Solving Therapy | Experimental | Participants who are assigned to receive problem-solving therapy will work with a research team member for six, one-hour sessions. During each session, participants will identify a problem (big or small) and create a plan to work on that problem. |
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| Stroke-Related Health Education | Active Comparator | Participants who are assigned to receive stroke-related health education will work with a research team member who will teach them about various topics related to stroke over six, one-hour sessions. Each session will cover information about a different topic related to stroke. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem-Solving Therapy | Behavioral | Problem-Solving Therapy is a brief psychosocial intervention for management of depressive symptoms. Participants will have six, one-hour sessions with an interventionist to learn a structured approach to problem-solving. |
| Measure | Description | Time Frame |
|---|---|---|
| Study Retention | Total percentage of participants who complete the study. | Through study completion, an average of 13 weeks. |
| Protocol Adherence | Total percentage of protocol-specified activities completed by enrolled participants. | Through study completion, an average of 13 weeks. |
| Intervention Acceptability | Participant experience collected via self-report survey. | Post-intervention, at approximately 8 weeks. |
| Study Recruitment Success | Percentage of eligible candidates who enroll in the study. | At initial contact. |
| Measure | Description | Time Frame |
|---|---|---|
| Pre/post-intervention changes in depressive symptoms among caregivers. | Pre/post-intervention changes in 9-item Patient Health Questionnaire (PHQ-9) scores. | Baseline and post-intervention, covering an average of 8 weeks. |
| Pre/post-intervention changes in quality of life among caregivers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allina Health | Minneapolis | Minnesota | 55407 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003863 | Depression |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Stroke-Related Health Education | Other | The stroke-related health education program will teach participants about various topics related to stroke. Participants will have six, one-hour sessions with an interventionist to learn about different topics related to stroke. |
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Pre/post-intervention changes in Euroqol 5-item QOL scale (EQ-5D) scores. |
| Baseline and post-intervention, covering an average of 8 weeks. |
| Pre/post-intervention changes in depressive symptoms among stoke survivors. | Pre/post-intervention changes in 9-item Patient Health Questionnaire (PHQ-9) scores. | Baseline and post-intervention, covering an average of 8 weeks. |
| Pre/post-intervention changes in quality of life among stoke survivors. | Pre/post-intervention changes in Euroqol 5-item QOL scale (EQ-5D) scores. | Baseline and post-intervention, covering an average of 8 weeks. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |