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

NCT04035681 | Completed

• 1 other identifier: 1368980-3
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Pre/post-intervention changes in depressive symptoms among caregivers.

  Baseline and post-intervention, covering an average of 8 weeks.

• 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 depressive symptoms among stoke survivors.

  Baseline and post-intervention, covering an average of 8 weeks.

• Pre/post-intervention changes in quality of life among stoke survivors.

  Baseline and post-intervention, covering an average of 8 weeks.

Study Arms (2)

Problem-Solving Therapy

EXPERIMENTAL

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

Stroke-Related Health Education

ACTIVE COMPARATOR

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

Interventions

Problem-Solving Therapy 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.

Problem-Solving Therapy

Stroke-Related Health Education 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.

Stroke-Related Health Education

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allina Health System: lead
• University of Minnesota: collaborator
• Agnes Marshall Walker Foundation: collaborator

Study Sites (1)

Allina Health

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Stroke; Depression

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 29, 2019
• Study Start: June 10, 2019
• Primary Completion: June 2, 2020
• Study Completion: July 22, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-03

Locations

US (1)