StrokeReStoreDNCT04845542
Promoting Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)
A study testing ReStoreD in people with Stroke and Depression, Anxiety, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Depression, Anxiety, Coping Skills
- What is being tested?
- ReStoreD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Depression, Anxiety, Coping Skills, Couples
- Being tested
- ReStoreD
- Medical subject headings
- Stroke, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReStoreDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ReStoreD |
| Waitlist-control | No intervention | Participants will be waitlisted for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (24)
Connor-Davidson Resilience Scale (CD-RISC)
10-item self-report measure of resilience; higher scores indicate greater resilience
Measured: baseline
Connor-Davidson Resilience Scale (CD-RISC)
10-item self-report measure of resilience; higher scores indicate greater resilience
Measured: 8 weeks
Connor-Davidson Resilience Scale (CD-RISC)
10-item self-report measure of resilience; higher scores indicate greater resilience
Measured: 16 weeks
Connor-Davidson Resilience Scale (CD-RISC)
10-item self-report measure of resilience; higher scores indicate greater resilience
Measured: 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
Measured: baseline
Dyadic Coping Inventory (DCI)-short
11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline
Zarit Burden Inventory-Short
12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start20 Jul 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
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.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Model description
- randomized waitlist control design
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Terrill, University of Utah
- Investigators
- Alexandra L Terrill, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845542
- Sponsor's protocol ID
- 1R01HD105718-01
- Acronym
- ReStoreD
- Status last verified
- Jan 2026
- First submitted
- 12 Apr 2021
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Efficacy of an Intervention to Promote Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)
- ClinicalTrials.gov ID
- NCT04845542
- Acronym / sponsor ID
- ReStoreD / 1R01HD105718-01
- Conditions
- Stroke, Depression, Anxiety, Coping Skills, Couples
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 15 Apr 2021 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized waitlist control design
| Arm | Type | Receives |
|---|---|---|
| ReStoreD | Experimental | Behavioral: ReStoreD8-week intervention that is remotely delivered, consisting of psychoeducation and positive psychology activities. Participants complete two activities individually and two together each week. |
| Waitlist-control | No intervention | –Participants will be waitlisted for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| ReStoreDReStoreD 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. | Behavioural | ReStoreD |
Primary outcome
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
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
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
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
24 secondary outcomes
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: baseline
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: 8 weeks
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: 16 weeks
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: 6 months
Dyadic Coping Inventory (DCI)-short
Time frame: baseline
Dyadic Coping Inventory (DCI)-short
Time frame: 8 weeks
Dyadic Coping Inventory (DCI)-short
Time frame: 16 weeks
Dyadic Coping Inventory (DCI)-short
Time frame: 6 months
Dyadic Relationship Scale
Time frame: baseline
Dyadic Relationship Scale
Time frame: 8 weeks
Dyadic Relationship Scale
Time frame: 16 weeks
Dyadic Relationship Scale
Time frame: 6 months
PROMIS-Psychosocial Illness Impact Scale-short form
Time frame: baseline
PROMIS-Psychosocial Illness Impact Scale-short form
Time frame: 8 weeks
PROMIS-Psychosocial Illness Impact Scale-short form
Time frame: 16 weeks
PROMIS-Psychosocial Illness Impact Scale-short form
Time frame: 6-months
Zarit Burden Inventory-Short
Time frame: baseline
Zarit Burden Inventory-Short
Time frame: 8 weeks
Zarit Burden Inventory-Short
Time frame: 16 weeks
Zarit Burden Inventory-Short
Time frame: 6 months
Meaningful Activity Participation Assessment (MAPA)
Time frame: baseline
Meaningful Activity Participation Assessment (MAPA)
Time frame: 8 weeks
Meaningful Activity Participation Assessment (MAPA)
Time frame: 16 weeks
Meaningful Activity Participation Assessment (MAPA)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Alexandra L Terrill, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReStoreD in people with Stroke and Depression, Anxiety, run by University of Utah 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form (time frame: Baseline). 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 30 Jan 2026.