Promoting Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)

NCT04845542 | Active Not Recruiting

• 1 other identifier: 1R01HD105718-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Affecting nearly 800,000 people in the US every year, stroke is a leading cause of long-term disability, and has serious consequences for stroke survivors and their carepartners. Our project uses a scientifically rigorous efficacy study to evaluate a remotely delivered 8-week dyadic (couples-based) positive psychology intervention to reduce emotional distress in stroke survivors and their carepartners. If successful, couples may be better emotionally equipped to cope with the sequelae of stroke, and have better rehabilitation outcomes and quality of life.

Conditions

Stroke; Depression, Anxiety; Coping Skills; Couples

Outcome Measures

Primary Outcomes (4)

• PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

  8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress

  Baseline

• PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

  8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress

  8 weeks

• PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

  8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress

  16 weeks

• PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

  8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress

  6 months

Secondary Outcomes (24)

• Connor-Davidson Resilience Scale (CD-RISC)

  baseline

• Connor-Davidson Resilience Scale (CD-RISC)

  8 weeks

• Connor-Davidson Resilience Scale (CD-RISC)

  16 weeks

• Connor-Davidson Resilience Scale (CD-RISC)

  6 months

• Dyadic Coping Inventory (DCI)-short

  baseline

Study Arms (2)

ReStoreD

EXPERIMENTAL

8-week intervention that is remotely delivered, consisting of psychoeducation and positive psychology activities. Participants complete two activities individually and two together each week.

Behavioral: ReStoreD

Waitlist-control

NO INTERVENTION

Participants will be waitlisted for 8 weeks.

Interventions

ReStoreD BEHAVIORAL

ReStoreD is a remotely-administered behavioral intervention in which couples coping with stroke learn and practice goal-setting, communication strategies, and positive psychology activities, such as expressing gratitude, finding meaning, and fostering connections. Participants are provided with 8 weekly modules, each featuring two components: 1) psychoeducational materials, such as an informational video and resources/links about a general topic related to resilience, coping, and/or overall well-being of the individual and couple, and 2) examples of positive psychology activities that relate to the week's theme or topic. Participants are asked to complete at least two positive psychology activities alone and two together each week.

ReStoreD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community-dwelling cohabitating couple where one partner has a had an ischemic or hemorrhagic stroke
• The stroke must have occurred between 3 months and 3 years prior to enrollment
• The adult couple must have been living together since before the stroke and for at least 6 months prior to enrollment
• One or both partners must report some anxiety and/or depressive symptoms
• Participants must be able to read, understand, and follow instructions, and be able to provide their own consent

You may not qualify if:

• Either dyad partner has significant aphasia (difficulties with speech), visual, psychiatric, and/or significant cognitive impairment that would limit their ability to participate in the intervention in a meaningful way

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Stroke; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexandra L Terrill, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized waitlist control design

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: July 20, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)