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

NCT ID: NCT04035681

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2020-07-22

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.

Conditions

Stroke; Quality of Life; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Problem-Solving Therapy

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Stroke-Related Health Education

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

Agnes Marshall Walker Foundation

UNKNOWN

Sponsor Role: collaborator

Allina Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Allina Health

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1368980-3

Identifier Type: -

Identifier Source: org_study_id