StrokeNCT04035681
Problem-Solving Therapy for Depressive Symptoms and Quality of Life in Stroke Survivor-Caregiver Dyads
A study testing Problem-Solving Therapy and Stroke-Related Health Education in people with Stroke and Quality of Life, run by Allina Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Quality of Life, Depression
- What is being tested?
- Problem-Solving Therapy and Stroke-Related Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2019to 22 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Problem-Solving Therapy, Stroke-Related Health Education
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Solving TherapyBehavioural
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 EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Stroke-Related Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Retention
Total percentage of participants who complete the study.
Measured: Through study completion, an average of 13 weeks.
Protocol Adherence
Total percentage of protocol-specified activities completed by enrolled participants.
Measured: Through study completion, an average of 13 weeks.
Intervention Acceptability
Participant experience collected via self-report survey.
Measured: Post-intervention, at approximately 8 weeks.
Study Recruitment Success
Percentage of eligible candidates who enroll in the study.
Measured: At initial contact.
Secondary outcomes (4)
Pre/post-intervention changes in depressive symptoms among caregivers.
Pre/post-intervention changes in 9-item Patient Health Questionnaire (PHQ-9) scores.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention, covering an average of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start10 Jun 2019
- Primary completion2 Jun 2020
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Agnes Marshall Walker Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035681
- Sponsor's protocol ID
- 1368980-3
- Status last verified
- Mar 2020
- First submitted
- 24 Jul 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Survivor-Caregiver Dyads: Feasibility of a Brief Psychosocial Intervention for Depressive Symptoms and Quality of Life
- ClinicalTrials.gov ID
- NCT04035681
- Acronym / sponsor ID
- 1368980-3
- Conditions
- Stroke, Quality of Life, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Collaborators
- University of Minnesota, Agnes Marshall Walker Foundation
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem-Solving Therapy | Experimental | Behavioral: Problem-Solving TherapyParticipants 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. |
| Stroke-Related Health Education | Active comparator | Other: Stroke-Related Health EducationParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem-Solving TherapyProblem-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. | Behavioural | Problem-Solving Therapy |
| Stroke-Related Health EducationThe 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. | Other | Stroke-Related Health Education |
Primary outcome
Study Retention
Time frame: Through study completion, an average of 13 weeks.
Total percentage of participants who complete the study.
Protocol Adherence
Time frame: Through study completion, an average of 13 weeks.
Total percentage of protocol-specified activities completed by enrolled participants.
Intervention Acceptability
Time frame: Post-intervention, at approximately 8 weeks.
Participant experience collected via self-report survey.
Study Recruitment Success
Time frame: At initial contact.
Percentage of eligible candidates who enroll in the study.
4 secondary outcomes
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 quality of life among caregivers.
Time frame: Baseline and post-intervention, covering an average of 8 weeks.
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 quality of life among stoke survivors.
Time frame: Baseline and post-intervention, covering an average of 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-Solving Therapy and Stroke-Related Health Education in people with Stroke and Quality of Life, run by Allina Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Retention (time frame: Through study completion, an average of 13 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.