Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Coping Skills
  • Couples
  • Depression, Anxiety
  • Stroke
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: randomized waitlist control designMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 s...

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.

Tracking Information

NCT #
NCT04845542
Collaborators
Not Provided
Investigators
Principal Investigator: Alexandra L Terrill, PhD University of Utah