Clinical trial NCT04845542: Promoting Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)
Official title: Testing Efficacy of an Intervention to Promote Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Depression, Anxiety
Coping Skills
Couples
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized waitlist control design
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Community-dwelling cohabitating couple where one partner has a had an ischemic or hemorrhagic stroke
* The stroke must have occurred between 3 months and 3 years prior to enrollment
* The adult couple must have been living together since before the stroke and for at least 6 months prior to enrollment
* One or both partners must report some anxiety and/or depressive symptoms
* Participants must be able to read, understand, and follow instructions, and be able to provide their own consent

Exclusion Criteria:

• Either dyad partner has significant aphasia (difficulties with speech), visual, psychiatric, and/or significant cognitive impairment that would limit their ability to participate in the intervention in a meaningful way

Primary outcomes:
measure: PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form
timeFrame: Baseline
measure: PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form
timeFrame: 8 weeks
measure: PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form
timeFrame: 16 weeks
measure: PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form
timeFrame: 6 months
Secondary outcomes:
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: baseline
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: 8 weeks
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: 16 weeks
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: 6 months
measure: Dyadic Coping Inventory (DCI)-short
timeFrame: baseline
measure: Dyadic Coping Inventory (DCI)-short
timeFrame: 8 weeks
measure: Dyadic Coping Inventory (DCI)-short
timeFrame: 16 weeks
measure: Dyadic Coping Inventory (DCI)-short
timeFrame: 6 months
measure: Dyadic Relationship Scale
timeFrame: baseline
measure: Dyadic Relationship Scale
timeFrame: 8 weeks
measure: Dyadic Relationship Scale
timeFrame: 16 weeks
measure: Dyadic Relationship Scale
timeFrame: 6 months
measure: PROMIS-Psychosocial Illness Impact Scale-short form
timeFrame: baseline
measure: PROMIS-Psychosocial Illness Impact Scale-short form
timeFrame: 8 weeks
measure: PROMIS-Psychosocial Illness Impact Scale-short form
timeFrame: 16 weeks
measure: PROMIS-Psychosocial Illness Impact Scale-short form
timeFrame: 6-months
measure: Zarit Burden Inventory-Short
timeFrame: baseline
measure: Zarit Burden Inventory-Short
timeFrame: 8 weeks
measure: Zarit Burden Inventory-Short
timeFrame: 16 weeks
measure: Zarit Burden Inventory-Short
timeFrame: 6 months
measure: Meaningful Activity Participation Assessment (MAPA)
timeFrame: baseline
measure: Meaningful Activity Participation Assessment (MAPA)
timeFrame: 8 weeks
measure: Meaningful Activity Participation Assessment (MAPA)
timeFrame: 16 weeks
measure: Meaningful Activity Participation Assessment (MAPA)
timeFrame: 6 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Alexandra L Terrill, PhD
role: PRINCIPAL_INVESTIGATOR
References: