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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment 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 survivors and their caregivers by promoting resilience and addressing emotional challenges together. ^{1 2 3 4 5}

Is the ReStoreD intervention safe for stroke survivors and their partners?

The ReStoreD intervention has been tested in a pilot study with stroke survivors and their partners, and no safety concerns were reported. It was designed to help couples cope with stroke-related changes and reduce depressive symptoms. ^{1 2 3 5 6}

How is the ReStoreD treatment unique for stroke survivors and their caregivers?

ReStoreD is unique because it focuses on building resilience in both stroke survivors and their caregivers as a pair, helping them cope with the challenges of stroke together. This approach is different from traditional treatments that often focus solely on the medical or physical aspects of stroke recovery. ^{1 2 4 5 7}

Research Team

Alexandra L Terrill, PhD

Principal Investigator

University of Utah

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Association between incongruence about survivor function and outcomes among stroke survivors and family caregivers. [2019]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Development of a novel positive psychology-based intervention for couples post-stroke. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The perspectives of spouses of stroke survivors on self-management - a focus group study. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Promoting Resilience After Stroke in Dyads (ReStoreD): A Supplemental Analysis. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Intimate Relationships and Stroke: Piloting a Dyadic Intervention to Improve Depression. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Patterns of relationships between background characteristics, coping, and stroke caregiver outcomes. [2021]