Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04845542
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2021-04-12
Brief Title:
Promoting Resilience in Stroke Survivor-carepartner Dyads ReStoreD
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Testing Efficacy of an Intervention to Promote Resilience in Stroke Survivor-carepartner Dyads ReStoreD
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReStoreD
Brief Summary:
Affecting nearly 800000 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 spousalpartner 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 n400 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 interventions 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
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 interventions 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None