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

Not Applicable

Completed

• Conditions: Stroke; Quality of Life; Depression
• Interventions: Other: Stroke-Related Health Education; Behavioral: Problem-Solving Therapy

• Registration Number: NCT04035681
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-10
• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Status Verified: 2020-03
• Primary Completion: 2020-06-02
• Study Completion: 2020-07-22
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stroke-Related Health Education	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.
Problem-Solving Therapy	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.

Primary Outcome Measures

Name	Time	Method
Study Retention	Through study completion, an average of 13 weeks.	Total percentage of participants who complete the study.
Protocol Adherence	Through study completion, an average of 13 weeks.	Total percentage of protocol-specified activities completed by enrolled participants.
Intervention Acceptability	Post-intervention, at approximately 8 weeks.	Participant experience collected via self-report survey.
Study Recruitment Success	At initial contact.	Percentage of eligible candidates who enroll in the study.

Secondary Outcome Measures

Name	Time	Method
Pre/post-intervention changes in depressive symptoms among caregivers.	Baseline and post-intervention, covering an average of 8 weeks.	Pre/post-intervention changes in 9-item Patient Health Questionnaire (PHQ-9) scores.
Pre/post-intervention changes in quality of life among caregivers.	Baseline and post-intervention, covering an average of 8 weeks.	Pre/post-intervention changes in Euroqol 5-item QOL scale (EQ-5D) scores.
Pre/post-intervention changes in depressive symptoms among stoke survivors.	Baseline and post-intervention, covering an average of 8 weeks.	Pre/post-intervention changes in 9-item Patient Health Questionnaire (PHQ-9) scores.
Pre/post-intervention changes in quality of life among stoke survivors.	Baseline and post-intervention, covering an average of 8 weeks.	Pre/post-intervention changes in Euroqol 5-item QOL scale (EQ-5D) scores.

Trial Locations

Locations (1)

Allina Health; 🇺🇸 Minneapolis, Minnesota, United States