Promoting Resilience in Stroke Survivor-carepartner Dyads (ReStoreD) (ReStoreD)

Testing Efficacy of an Intervention to Promote Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Depression, Anxiety; Coping Skills; Couples
• Intervention / Treatment: Behavioral: ReStoreD

Detailed Description

The impact of stroke is shared between the stroke survivor and their spousal/partner caregiver (carepartner). An estimated 30-50% of stroke survivors and carepartners experience depressive or anxiety symptoms that negatively affect rehabilitation outcomes and quality of life. Yet, interventions to support couples post-stroke are largely insufficient or inaccessible. To address this need, we developed a novel remotely-delivered dyadic intervention to promote Resilience in Stroke survivor-carepartner Dyads (ReStoreD), in which couples learn and practice goal-setting, communication strategies, and positive psychology activities like expressing gratitude, finding meaning, and fostering connections. Preliminary pilot study results were promising, showing reduced depressive symptoms and increased resilience in participants. The purpose of the current study is to conduct a Stage II efficacy trial of the 8-week ReStoreD intervention with a sample of 200 dyads (n=400) consisting of one individual who has sustained an ischemic or hemorrhagic stroke between 3 months and 3 years prior to enrollment and a cohabitating carepartner. Using a fully-powered, randomized waitlist-control design, we will determine efficacy of ReStoreD to reduce emotional distress in both dyad members (Aim 1). We will also examine effects of ReStoreD on secondary outcomes (resilience, relationship quality, stress-related stroke, meaningful activity engagement) as potential mediators (Aim 2), and explore moderators to determine whether certain subgroups respond better to the intervention (Aim 3). All participants will complete standardized, validated assessments at baseline, 8 weeks, 16 weeks, and 6-month follow up. All aspects of the study, including intervention activities and assessments, are conducted remotely, online.

This is the first rigorously designed efficacy trial to test a positive psychology intervention for stroke survivors and their carepartners. When the aims of this study are realized, we will 1) have a remotely-delivered, dyadic intervention to support couples post-stroke; 2) have a better understanding of the mechanisms involved in the intervention's effect on emotional distress, and can use this information to inform future interventions; and 3) be able to identify a more specific target population for whom the intervention works best. Ultimately, if found efficacious, this intervention will offer sustainable and accessible support for couples who are coping with stroke to improve rehabilitation outcomes and quality of life.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ReStoreD; 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; 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.
No Intervention: Waitlist-control; Participants will be waitlisted for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Connor-Davidson Resilience Scale (CD-RISC)	10-item self-report measure of resilience; higher scores indicate greater resilience	baseline
Connor-Davidson Resilience Scale (CD-RISC)	10-item self-report measure of resilience; higher scores indicate greater resilience	8 weeks
Connor-Davidson Resilience Scale (CD-RISC)	10-item self-report measure of resilience; higher scores indicate greater resilience	16 weeks
Connor-Davidson Resilience Scale (CD-RISC)	10-item self-report measure of resilience; higher scores indicate greater resilience	6 months
Dyadic Coping Inventory (DCI)-short	11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping	baseline
Dyadic Coping Inventory (DCI)-short	11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping	8 weeks
Dyadic Coping Inventory (DCI)-short	11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping	16 weeks
Dyadic Coping Inventory (DCI)-short	11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping	6 months
Dyadic Relationship Scale	Self report measure that assesses care-recipient-caregiver relationship and includes 2 subscales: Dyadic Strain (5 items; higher scores mean more strain) and Positive Dyadic Interactions (6 items; higher scores mean more positive interactions)	baseline
Dyadic Relationship Scale	Self report measure that assesses care-recipient-caregiver relationship and includes 2 subscales: Dyadic Strain (5 items; higher scores mean more strain) and Positive Dyadic Interactions (6 items; higher scores mean more positive interactions)	8 weeks
Dyadic Relationship Scale	Self report measure that assesses care-recipient-caregiver relationship and includes 2 subscales: Dyadic Strain (5 items; higher scores mean more strain) and Positive Dyadic Interactions (6 items; higher scores mean more positive interactions)	16 weeks
Dyadic Relationship Scale	Self report measure that assesses care-recipient-caregiver relationship and includes 2 subscales: Dyadic Strain (5 items; higher scores mean more strain) and Positive Dyadic Interactions (6 items; higher scores mean more positive interactions)	6 months
PROMIS-Psychosocial Illness Impact Scale-short form	8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress.	baseline
PROMIS-Psychosocial Illness Impact Scale-short form	8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress.	8 weeks
PROMIS-Psychosocial Illness Impact Scale-short form	8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress.	16 weeks
PROMIS-Psychosocial Illness Impact Scale-short form	8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress.	6-months
Zarit Burden Inventory-Short	12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden	baseline
Zarit Burden Inventory-Short	12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden	8 weeks
Zarit Burden Inventory-Short	12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden	16 weeks
Zarit Burden Inventory-Short	12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden	6 months
Meaningful Activity Participation Assessment (MAPA)	28 activity items are rated on frequency of engaging in these activities (higher score means more frequent) and how meaningful they are to the person (higher score means more meaningful)	baseline
Meaningful Activity Participation Assessment (MAPA)	28 activity items are rated on frequency of engaging in these activities (higher score means more frequent) and how meaningful they are to the person (higher score means more meaningful)	8 weeks
Meaningful Activity Participation Assessment (MAPA)	28 activity items are rated on frequency of engaging in these activities (higher score means more frequent) and how meaningful they are to the person (higher score means more meaningful)	16 weeks
Meaningful Activity Participation Assessment (MAPA)	28 activity items are rated on frequency of engaging in these activities (higher score means more frequent) and how meaningful they are to the person (higher score means more meaningful)	6 months

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Alexandra L Terrill, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Stroke; Anxiety Disorders; Depression
• Other Study ID Numbers: 1R01HD105718-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No