Resilience in Stroke survivor-care-partner Dyads (ReStoreD): a study protocol for a randomized-control trial

Abstract

Background: The impact of stroke is shared between the stroke survivor and their care-partner. An estimated 30–50% of stroke survivors and their care-partners experience depression or anxiety that negatively affects rehabilitation outcomes and quality of life. Yet, interventions to support couples post-stroke are largely insufficient or inaccessible. A novel remotely delivered dyadic intervention to promote Resilience in Stroke survivor-care-partner Dyads (ReStoreD) was developed to address this need. The intervention includes psychoeducation and weekly modules that help couples learn and practice goal-setting, communication strategies, and positive psychology activities like expressing gratitude, finding meaning, and fostering connections. 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 one individual who has sustained an ischemic or hemorrhagic stroke between 3 months and 3 years prior to enrollment and a cohabitating partner. Methods: Using a fully powered, randomized waitlist-control design, the efficacy of ReStoreD to reduce emotional distress in both dyad members will be determined (Aim 1). In addition, the effects of ReStoreD on secondary outcomes (resilience, relationship quality, stress-related stroke, meaningful activity engagement) as potential mediators (Aim 2) and moderators to determine whether certain subgroups respond better to the intervention (Aim 3) will be examined. 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. Discussion: This is the first rigorously designed efficacy trial to test a positive psychology intervention for stroke survivors and their care-partners. When the aims of this study are realized, there will be (1) a remotely delivered, dyadic intervention to support couples post-stroke; (2) a better understanding of the mechanisms involved in the intervention’s effect on emotional distress, which can inform future interventions; and (3) the ability 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. Trial registration: This trial is registered at ClinicalTrials.gov at NCT#04845542. Registered on April 13, 2021.