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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04035681
Recruitment Status : Active, not recruiting
First Posted : July 29, 2019
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
University of Minnesota
Agnes Marshall Walker Foundation
Information provided by (Responsible Party):
Allina Health System

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.


Condition or disease Intervention/treatment Phase
Stroke Quality of Life Depression Behavioral: Problem-Solving Therapy Other: Stroke-Related Health Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Stroke Survivor-Caregiver Dyads: Feasibility of a Brief Psychosocial Intervention for Depressive Symptoms and Quality of Life
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Problem-Solving Therapy
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
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.

Active Comparator: Stroke-Related Health Education
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
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 Measures :
  1. Study Retention [ Time Frame: Through study completion, an average of 13 weeks. ]
    Total percentage of participants who complete the study.

  2. Protocol Adherence [ Time Frame: Through study completion, an average of 13 weeks. ]
    Total percentage of protocol-specified activities completed by enrolled participants.

  3. Intervention Acceptability [ Time Frame: Post-intervention, at approximately 8 weeks. ]
    Participant experience collected via self-report survey.

  4. Study Recruitment Success [ Time Frame: At initial contact. ]
    Percentage of eligible candidates who enroll in the study.


Secondary Outcome Measures :
  1. Pre/post-intervention changes in depressive symptoms among caregivers. [ Time Frame: Baseline and post-intervention, covering an average of 8 weeks. ]
    Pre/post-intervention changes in 9-item Patient Health Questionnaire (PHQ-9) scores.

  2. Pre/post-intervention changes in quality of life among caregivers. [ Time Frame: Baseline and post-intervention, covering an average of 8 weeks. ]
    Pre/post-intervention changes in Euroqol 5-item QOL scale (EQ-5D) scores.

  3. Pre/post-intervention changes in depressive symptoms among stoke survivors. [ Time Frame: Baseline and post-intervention, covering an average of 8 weeks. ]
    Pre/post-intervention changes in 9-item Patient Health Questionnaire (PHQ-9) scores.

  4. Pre/post-intervention changes in quality of life among stoke survivors. [ Time Frame: Baseline and post-intervention, covering an average of 8 weeks. ]
    Pre/post-intervention changes in Euroqol 5-item QOL scale (EQ-5D) scores.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035681


Locations
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United States, Minnesota
Allina Health
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Allina Health System
University of Minnesota
Agnes Marshall Walker Foundation

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Responsible Party: Allina Health System
ClinicalTrials.gov Identifier: NCT04035681    
Other Study ID Numbers: 1368980-3
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Depression
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms