Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04845542

Promoting 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Stroke Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coping Skills Couples Depression Depression, Anxiety Mental Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

Primary outcomes

  1. PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

    Time frame: Baseline

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

  2. PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

    Time frame: 8 weeks

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

  3. PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

    Time frame: 16 weeks

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

  4. PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form

    Time frame: 6 months

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

Secondary outcomes

  1. Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: baseline

    10-item self-report measure of resilience; higher scores indicate greater resilience

  2. Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: 8 weeks

    10-item self-report measure of resilience; higher scores indicate greater resilience

  3. Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: 16 weeks

    10-item self-report measure of resilience; higher scores indicate greater resilience

  4. Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: 6 months

    10-item self-report measure of resilience; higher scores indicate greater resilience

  5. Dyadic Coping Inventory (DCI)-short

    Time frame: baseline

    11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping

  6. Dyadic Coping Inventory (DCI)-short

    Time frame: 8 weeks

    11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping

  7. Dyadic Coping Inventory (DCI)-short

    Time frame: 16 weeks

    11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping

  8. Dyadic Coping Inventory (DCI)-short

    Time frame: 6 months

    11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping

  9. Dyadic Relationship Scale

    Time frame: baseline

    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)

  10. Dyadic Relationship Scale

    Time frame: 8 weeks

    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)

  11. Dyadic Relationship Scale

    Time frame: 16 weeks

    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)

  12. Dyadic Relationship Scale

    Time frame: 6 months

    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)

  13. PROMIS-Psychosocial Illness Impact Scale-short form

    Time frame: baseline

    8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress.

  14. PROMIS-Psychosocial Illness Impact Scale-short form

    Time frame: 8 weeks

    8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress.

  15. PROMIS-Psychosocial Illness Impact Scale-short form

    Time frame: 16 weeks

    8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress.

  16. PROMIS-Psychosocial Illness Impact Scale-short form

    Time frame: 6-months

    8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress.

  17. Zarit Burden Inventory-Short

    Time frame: baseline

    12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden

  18. Zarit Burden Inventory-Short

    Time frame: 8 weeks

    12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden

  19. Zarit Burden Inventory-Short

    Time frame: 16 weeks

    12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden

  20. Zarit Burden Inventory-Short

    Time frame: 6 months

    12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden

  21. Meaningful Activity Participation Assessment (MAPA)

    Time frame: baseline

    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)

  22. Meaningful Activity Participation Assessment (MAPA)

    Time frame: 8 weeks

    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)

  23. Meaningful Activity Participation Assessment (MAPA)

    Time frame: 16 weeks

    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)

  24. Meaningful Activity Participation Assessment (MAPA)

    Time frame: 6 months

    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)

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Acronym: ReStoreD

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 15, 2021
Registry last updated
Jan 30, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.