Problem-Solving Therapy for Depressive Symptoms and Quality of Life in Stroke Survivor-Caregiver Dyads

Study Overview
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Brief Summary
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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.

Official Title
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Stroke Survivor-Caregiver Dyads: Feasibility of a Brief Psychosocial Intervention for Depressive Symptoms and Quality of Life

Conditions
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Stroke, Quality of Life, Depression

Intervention / Treatment
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* Behavioral: Problem-Solving Therapy
* Other: Stroke-Related Health Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both dyad participants are at least 18 years of age. The stroke survivor experienced an ischemic or hemorrhagic stroke at least 3 months prior to enrollment. The caregiver is a spouse/partner who provides regular, unpaid support for the survivor in activities of daily living. Both dyad members are willing and able understand and comply with protocol requirements. Exclusion Criteria: The stroke survivor has severe expressive or receptive aphasia or global aphasia, as documented in the medical record by a speech pathologist or other provider. Either dyad member is unable to write, as this will interfere with completion of MiniCog assessment. Either dyad member has significant cognitive impairment, evidenced by MiniCog score <4 at screening. Either dyad member reports an intent to harm him/herself or others. Either dyad member has any concurrent conditions that would interfere with participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Problem-Solving Therapy<br>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. | Behavioral: Problem-Solving Therapy<br>* 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.<br>|
| Active Comparator: Stroke-Related Health Education<br>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. | Other: Stroke-Related Health Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. |