ReStoreD for Stroke Survivor-carepartner Coping

(ReStoreD Trial)

Overseen By Lorie Richards, PhD, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Aphasia, Visual, Psychiatric, Cognitive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help stroke survivors and their partners manage emotional distress through an 8-week program called ReStoreD (Resilience in Stroke Survivor-Care Partner Dyads). The program includes positive psychology activities designed for both individual and couple participation, all delivered remotely. Participants will either begin the program immediately or join a waitlist for 8 weeks. The trial seeks couples living together where one partner experienced a stroke within the past 3 months to 3 years and reports anxiety or depression. As an unphased study, this trial offers a unique opportunity to explore innovative support strategies for emotional well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for stroke survivors and their carepartners?

Research has shown that the ReStoreD program was tested in a small study with stroke survivors and their partners, and no safety issues emerged. This treatment is an 8-week program conducted remotely, using activities and information to help reduce emotional distress. Since earlier tests revealed no safety problems, it appears well-tolerated. Participants reported no negative side effects. Current evidence suggests ReStoreD is safe for similar groups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ReStoreD intervention for stroke survivors and their care partners because it offers a unique approach to coping with post-stroke challenges. Unlike traditional treatments that might focus solely on physical rehabilitation, ReStoreD emphasizes psychological well-being through an 8-week program that combines psychoeducation and positive psychology activities. Delivered remotely, this intervention allows participants to engage in two individual activities and two joint activities each week, promoting mental resilience and strengthening the care partner relationship. This holistic and accessible approach sets it apart from more conventional stroke recovery methods that may not address the emotional and relational aspects of recovery.

What evidence suggests that the ReStoreD intervention is effective for reducing emotional distress in stroke survivors and their carepartners?

Research has shown that programs like ReStoreD, which focus on couples, can help stroke survivors and their partners cope better, improve their quality of life, and boost emotional health. In this trial, participants will either receive the ReStoreD intervention or be placed in a waitlist-control group. Studies have found that 30–50% of stroke survivors and their partners experience depression or anxiety, which can hinder recovery. ReStoreD aims to reduce emotional distress by using activities that promote positive thinking and provide education over an 8-week period. This program is designed to help couples handle the challenges that follow a stroke. Early results suggest that these programs can lead to better recovery and a higher quality of life for both individuals involved. ^{1 2 3 4 6}

Who Is on the Research Team?

Alexandra L Terrill, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants must be able to read, understand, and follow instructions, and be able to provide their own consent

My partner and I live together and one of us had a stroke.

Either I or my partner experience anxiety or depression.

Exclusion Criteria

Either I or my partner have significant speech, vision, mental health, or cognitive issues that would prevent us from fully participating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week remotely delivered dyadic positive psychology intervention

8 weeks

All activities conducted remotely

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 8 weeks, 16 weeks, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• ReStoreD

Trial Overview 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.

How Is the Trial Designed?

Group I: ReStoreD Experimental Treatment 1 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-control Active Control 1 Intervention

Participants will be waitlisted for 8 weeks.

ReStoreD is already approved in United States for the following indications:

Approved in United States as ReStoreD for:

• Reducing emotional distress in stroke survivors and their carepartners

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

The ReStoreD intervention, an 8-week program for couples coping with stroke, significantly improved resilience in individuals who had a stroke, with results showing a large effect size that was maintained at a 3-month follow-up.

Care partners did not show significant changes in resilience over time, indicating that while the intervention benefits stroke survivors, further research is needed to support the mental health needs of care partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Resilience After Stroke in Dyads (ReStoreD): A Supplemental Analysis. Terrill, AL., Reblin, M., MacKenzie, JJ., et al.[2023]

The ReStoreD intervention, a novel 8-week remotely administered program, showed a large effect size in reducing depressive symptoms among stroke survivors, although it did not reach statistical significance.

While the intervention did not significantly improve depressive symptoms in partners, those with more severe baseline symptoms were more likely to benefit, indicating potential for targeted future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intimate Relationships and Stroke: Piloting a Dyadic Intervention to Improve Depression. Terrill, AL., Reblin, M., MacKenzie, JJ., et al.[2023]

A dyadic positive psychology-based intervention (PPI) for stroke survivors and their caregivers was found to be feasible, with 10 out of 11 enrolled couples completing the 8-week program and engaging in activities together.

Participants reported high satisfaction with the intervention, indicating its potential as a supportive tool for improving emotional health in couples coping with the aftermath of a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a novel positive psychology-based intervention for couples post-stroke. Terrill, AL., Reblin, M., MacKenzie, JJ., et al.[2021]

Spouses of stroke survivors experience significant emotional challenges, including feelings of burden, loneliness, and guilt, which impact their ability to manage both their own well-being and their partner's care.

Involving spouses in stroke rehabilitation programs is crucial, as they often take on co-management roles and need support for their emotional health and caregiving skills, with peer support being beneficial for both spouses and stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The perspectives of spouses of stroke survivors on self-management - a focus group study. Satink, T., Cup, EHC., de Swart, BJM., et al.[2018]

Stroke survivors often perceive their cognitive functions, like memory and thinking, as better than their caregivers do, leading to significant incongruence in appraisals.

This incongruence does not improve over time and is linked to increased distress and depressive symptoms in both survivors and caregivers, suggesting a need for strategies to address these differences for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between incongruence about survivor function and outcomes among stroke survivors and family caregivers. McCarthy, MJ., Bakas, T., Schellinger, J., et al.[2019]

Dyadic psycho-social interventions significantly improved functional independence and reduced depressive symptoms in stroke survivors, based on a systematic review of 15 randomized controlled trials involving 2,190 patients and 1,933 caregivers.

These interventions also alleviated the care burden on caregivers, suggesting they are effective strategies for addressing the psycho-social challenges faced by both stroke survivors and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic psycho-social interventions for stroke survivors and family caregivers: A systematic review and meta-analysis of randomized controlled trials. Zhang, XY., Sha, KH., Ma, XY., et al.[2023]

In a study of 253 caregiver-stroke survivor dyads, greater threat appraisal was linked to negative life changes, increased anxiety, and lower preparedness for caregiving, highlighting the psychological challenges caregivers face.

Caregiver characteristics, such as being nonwhite or a spousal caregiver, were associated with better outcomes like positive life change and lower anxiety, suggesting that understanding these traits can help tailor interventions to support caregivers effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of relationships between background characteristics, coping, and stroke caregiver outcomes. King, RB., Hartke, RJ., Houle, TT.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40468387/

Resilience in Stroke survivor-care-partner Dyads (ReStoreD) The purpose of this study is to conduct an efficacy trial of the 8-week ReStoreD intervention with a sample of 200 dyads (n = 400) consisting of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12139354/

Resilience in Stroke survivor-care-partner Dyads (ReStoreD) An estimated 30–50% of stroke survivors and their care-partners experience depression or anxiety that negatively affects rehabilitation outcomes ...

3. researchgate.net researchgate.net/publication/392404618_Resilience_in_Stroke_survivor-care-partner_Dyads_ReStoreD_a_study_protocol_for_a_randomized-control_trial

(PDF) Resilience in Stroke survivor-care-partner Dyads ... The purpose of this study is to conduct an efficacy trial of the 8-week ReStoreD intervention with a sample of 200 dyads (n = 400) consisting of ...

4. withpower.com withpower.com/trial/phase-stroke-6-2021-039d6

ReStoreD for Stroke Survivor-carepartner Coping Research suggests that dyadic psycho-social interventions, like ReStoreD, can improve coping ability, quality of life, and emotional health for both stroke ...

5. adaa.trialstoday.org adaa.trialstoday.org/trial/NCT04845542

Anxiety & Depression Association of America To address this need, we developed a novel remotely-delivered dyadic intervention to promote Resilience in Stroke survivor-carepartner Dyads ( ...

6. clinicaltrial.be clinicaltrial.be/en/details/45117?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Promoting Resilience in Stroke Survivor-carepartner Dyads... 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) ...