Promoting Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Testing Efficacy of an Intervention to Promote Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)

Conditions
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Stroke, Depression, Anxiety, Coping Skills, Couples

Intervention / Treatment
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* Behavioral: ReStoreD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized waitlist control design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReStoreD<br>8-week intervention that is remotely delivered, consisting of psychoeducation and positive psychology activities. Participants complete two activities individually and two together each week. | Behavioral: ReStoreD<br>* ReStoreD is a remotely-administered behavioral intervention in which couples coping with stroke learn and practice goal-setting, communication strategies, and positive psychology activities, such as expressing gratitude, finding meaning, and fostering connections. Participants are provided with 8 weekly modules, each featuring two components: 1) psychoeducational materials, such as an informational video and resources/links about a general topic related to resilience, coping, and/or overall well-being of the individual and couple, and 2) examples of positive psychology activities that relate to the week's theme or topic. Participants are asked to complete at least two positive psychology activities alone and two together each week.<br>|
| No Intervention: Waitlist-control<br>Participants will be waitlisted for 8 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form | 8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress | Baseline | 
| PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form | 8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress | 8 weeks | 
| PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form | 8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress | 16 weeks | 
| PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form | 8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Connor-Davidson Resilience Scale (CD-RISC) | 10-item self-report measure of resilience; higher scores indicate greater resilience | baseline | 
| Connor-Davidson Resilience Scale (CD-RISC) | 10-item self-report measure of resilience; higher scores indicate greater resilience | 8 weeks | 
| Connor-Davidson Resilience Scale (CD-RISC) | 10-item self-report measure of resilience; higher scores indicate greater resilience | 16 weeks | 
| Connor-Davidson Resilience Scale (CD-RISC) | 10-item self-report measure of resilience; higher scores indicate greater resilience | 6 months | 
| Dyadic Coping Inventory (DCI)-short | 11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping | baseline | 
| Dyadic Coping Inventory (DCI)-short | 11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping | 8 weeks | 
| Dyadic Coping Inventory (DCI)-short | 11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping | 16 weeks | 
| Dyadic Coping Inventory (DCI)-short | 11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping | 6 months | 
| Dyadic Relationship Scale | Self report measure that assesses care-recipient-caregiver relationship and includes 2 subscales: Dyadic Strain (5 items; higher scores mean more strain) and Positive Dyadic Interactions (6 items; higher scores mean more positive interactions) | baseline | 
| Dyadic Relationship Scale | Self report measure that assesses care-recipient-caregiver relationship and includes 2 subscales: Dyadic Strain (5 items; higher scores mean more strain) and Positive Dyadic Interactions (6 items; higher scores mean more positive interactions) | 8 weeks | 
| Dyadic Relationship Scale | Self report measure that assesses care-recipient-caregiver relationship and includes 2 subscales: Dyadic Strain (5 items; higher scores mean more strain) and Positive Dyadic Interactions (6 items; higher scores mean more positive interactions) | 16 weeks | 
| Dyadic Relationship Scale | Self report measure that assesses care-recipient-caregiver relationship and includes 2 subscales: Dyadic Strain (5 items; higher scores mean more strain) and Positive Dyadic Interactions (6 items; higher scores mean more positive interactions) | 6 months | 
| PROMIS-Psychosocial Illness Impact Scale-short form | 8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress. | baseline | 
| PROMIS-Psychosocial Illness Impact Scale-short form | 8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress. | 8 weeks | 
| PROMIS-Psychosocial Illness Impact Scale-short form | 8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress. | 16 weeks | 
| PROMIS-Psychosocial Illness Impact Scale-short form | 8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress. | 6-months | 
| Zarit Burden Inventory-Short | 12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden | baseline | 
| Zarit Burden Inventory-Short | 12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden | 8 weeks | 
| Zarit Burden Inventory-Short | 12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden | 16 weeks | 
| Zarit Burden Inventory-Short | 12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden | 6 months | 
| Meaningful Activity Participation Assessment (MAPA) | 28 activity items are rated on frequency of engaging in these activities (higher score means more frequent) and how meaningful they are to the person (higher score means more meaningful) | baseline | 
| Meaningful Activity Participation Assessment (MAPA) | 28 activity items are rated on frequency of engaging in these activities (higher score means more frequent) and how meaningful they are to the person (higher score means more meaningful) | 8 weeks | 
| Meaningful Activity Participation Assessment (MAPA) | 28 activity items are rated on frequency of engaging in these activities (higher score means more frequent) and how meaningful they are to the person (higher score means more meaningful) | 16 weeks | 
| Meaningful Activity Participation Assessment (MAPA) | 28 activity items are rated on frequency of engaging in these activities (higher score means more frequent) and how meaningful they are to the person (higher score means more meaningful) | 6 months |