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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
400
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.
University of Utah
Salt Lake City, Utah, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
Connor-Davidson Resilience Scale (CD-RISC)
10-item self-report measure of resilience; higher scores indicate greater resilience
Time frame: baseline
Connor-Davidson Resilience Scale (CD-RISC)
10-item self-report measure of resilience; higher scores indicate greater resilience
Time frame: 8 weeks
Connor-Davidson Resilience Scale (CD-RISC)
10-item self-report measure of resilience; higher scores indicate greater resilience
Time frame: 16 weeks
Connor-Davidson Resilience Scale (CD-RISC)
10-item self-report measure of resilience; higher scores indicate greater resilience
Time frame: 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
Time frame: baseline
Dyadic Coping Inventory (DCI)-short
11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: baseline
Zarit Burden Inventory-Short
12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.