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Behavioral Intervention
ReStoreD for Stroke Survivor-carepartner Coping (ReStoreD Trial)
N/A
Recruiting
Led By Alexandra L Terrill, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Community-dwelling cohabitating couple where one partner has a had an ischemic or hemorrhagic stroke
Community-dwelling cohabitating couple where one partner has had an ischemic or hemorrhagic stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a remotely delivered 8-week intervention to help reduce emotional distress for stroke survivors and their carepartners. If successful, this could help improve quality of life for couples affected by stroke.
Who is the study for?
This trial is for couples living together where one partner has experienced a stroke between 3 months and 3 years ago, and either partner shows signs of anxiety or depression. They must be able to understand instructions and consent. Couples can't join if either has severe speech issues, visual impairments, psychiatric conditions, or cognitive disabilities.
What is being tested?
The ReStoreD program is being tested in this study. It's an 8-week positive psychology intervention delivered remotely to couples (dyads) aiming to reduce emotional distress in both stroke survivors and their carepartners.
What are the potential side effects?
Since ReStoreD is a psychological intervention rather than a medication, it may not have typical 'side effects,' but participants might experience emotional discomfort when discussing sensitive topics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My partner and I live together and one of us had a stroke.
Select...
My partner and I live together and one of us had a stroke.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form
Secondary study objectives
Connor-Davidson Resilience Scale (CD-RISC)
Dyadic Coping Inventory (DCI)-short
Dyadic Relationship Scale
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ReStoreDExperimental Treatment1 Intervention
8-week intervention that is remotely delivered, consisting of psychoeducation and positive psychology activities. Participants complete two activities individually and two together each week.
Group II: Waitlist-controlActive Control1 Intervention
Participants will be waitlisted for 8 weeks.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,697,386 Total Patients Enrolled
20 Trials studying Stroke
3,077 Patients Enrolled for Stroke
Alexandra L Terrill, PhDPrincipal InvestigatorUniversity of Utah
2 Previous Clinical Trials
236 Total Patients Enrolled
1 Trials studying Stroke
68 Patients Enrolled for Stroke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Either I or my partner have significant speech, vision, mental health, or cognitive issues that would prevent us from fully participating.My partner and I live together and one of us had a stroke.Either I or my partner experience anxiety or depression.My partner and I live together and one of us had a stroke.My stroke happened between 3 months and 3 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: ReStoreD
- Group 2: Waitlist-control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Stroke Patient Testimony for trial: Trial Name: NCT04845542 — N/A
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