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

Primary Purpose

Stroke, Quality of Life, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem-Solving Therapy
Stroke-Related Health Education
Sponsored by
Allina Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Both dyad participants are at least 18 years of age.
  2. The stroke survivor experienced an ischemic or hemorrhagic stroke at least 3 months prior to enrollment.
  3. The caregiver is a spouse/partner who provides regular, unpaid support for the survivor in activities of daily living.
  4. Both dyad members are willing and able understand and comply with protocol requirements.

Exclusion Criteria:

  1. 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.
  2. Either dyad member is unable to write, as this will interfere with completion of MiniCog assessment.
  3. Either dyad member has significant cognitive impairment, evidenced by MiniCog score <4 at screening.
  4. Either dyad member reports an intent to harm him/herself or others.
  5. Either dyad member has any concurrent conditions that would interfere with participation.

Sites / Locations

  • Allina Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Problem-Solving Therapy

Stroke-Related Health Education

Arm Description

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

Primary Outcome Measures

Study Retention
Total percentage of participants who complete the study.
Protocol Adherence
Total percentage of protocol-specified activities completed by enrolled participants.
Intervention Acceptability
Participant experience collected via self-report survey.
Study Recruitment Success
Percentage of eligible candidates who enroll in the study.

Secondary Outcome Measures

Pre/post-intervention changes in depressive symptoms among caregivers.
Pre/post-intervention changes in 9-item Patient Health Questionnaire (PHQ-9) scores.
Pre/post-intervention changes in quality of life among caregivers.
Pre/post-intervention changes in Euroqol 5-item QOL scale (EQ-5D) scores.
Pre/post-intervention changes in depressive symptoms among stoke survivors.
Pre/post-intervention changes in 9-item Patient Health Questionnaire (PHQ-9) scores.
Pre/post-intervention changes in quality of life among stoke survivors.
Pre/post-intervention changes in Euroqol 5-item QOL scale (EQ-5D) scores.

Full Information

First Posted
July 24, 2019
Last Updated
September 1, 2020
Sponsor
Allina Health System
Collaborators
University of Minnesota, Agnes Marshall Walker Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04035681
Brief Title
Problem-Solving Therapy for Depressive Symptoms and Quality of Life in Stroke Survivor-Caregiver Dyads
Official Title
Stroke Survivor-Caregiver Dyads: Feasibility of a Brief Psychosocial Intervention for Depressive Symptoms and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
June 2, 2020 (Actual)
Study Completion Date
July 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allina Health System
Collaborators
University of Minnesota, Agnes Marshall Walker Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Quality of Life, Depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem-Solving Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Stroke-Related Health Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Problem-Solving Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stroke-Related Health Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Study Retention
Description
Total percentage of participants who complete the study.
Time Frame
Through study completion, an average of 13 weeks.
Title
Protocol Adherence
Description
Total percentage of protocol-specified activities completed by enrolled participants.
Time Frame
Through study completion, an average of 13 weeks.
Title
Intervention Acceptability
Description
Participant experience collected via self-report survey.
Time Frame
Post-intervention, at approximately 8 weeks.
Title
Study Recruitment Success
Description
Percentage of eligible candidates who enroll in the study.
Time Frame
At initial contact.
Secondary Outcome Measure Information:
Title
Pre/post-intervention changes in depressive symptoms among caregivers.
Description
Pre/post-intervention changes in 9-item Patient Health Questionnaire (PHQ-9) scores.
Time Frame
Baseline and post-intervention, covering an average of 8 weeks.
Title
Pre/post-intervention changes in quality of life among caregivers.
Description
Pre/post-intervention changes in Euroqol 5-item QOL scale (EQ-5D) scores.
Time Frame
Baseline and post-intervention, covering an average of 8 weeks.
Title
Pre/post-intervention changes in depressive symptoms among stoke survivors.
Description
Pre/post-intervention changes in 9-item Patient Health Questionnaire (PHQ-9) scores.
Time Frame
Baseline and post-intervention, covering an average of 8 weeks.
Title
Pre/post-intervention changes in quality of life among stoke survivors.
Description
Pre/post-intervention changes in Euroqol 5-item QOL scale (EQ-5D) scores.
Time Frame
Baseline and post-intervention, covering an average of 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Allina Health
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States

12. IPD Sharing Statement

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

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