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Completed

NCT Number: NCT04035681

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

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.

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Key information

Conditions

Stroke Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Nervous System Diseases Quality of Life Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allina Health

Minneapolis, Minnesota, 55407, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Collaborators

  • Agnes Marshall Walker Foundation
  • University of Minnesota

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2019
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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