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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stroke; Quality of Life
• Intervention / Treatment: Behavioral: Problem-Solving Therapy; Other: Stroke-Related Health Education

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Allina Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Allina Health System
• Collaborators: University of Minnesota; Agnes Marshall Walker Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): June 2, 2020
• Study Completion (Actual): July 22, 2020

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Depression
• Other Study ID Numbers: 1368980-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No