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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04845542
Other study ID # 1R01HD105718-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 20, 2022
Est. completion date August 31, 2027

Study information

Verified date November 2023
Source University of Utah
Contact Alexandra L Terrill, PhD
Phone 8015815951
Email alex.terrill@hsc.utah.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date August 31, 2027
Est. primary completion date August 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ReStoreD
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.

Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Connor-Davidson Resilience Scale (CD-RISC) 10-item self-report measure of resilience; higher scores indicate greater resilience baseline
Secondary Connor-Davidson Resilience Scale (CD-RISC) 10-item self-report measure of resilience; higher scores indicate greater resilience 8 weeks
Secondary Connor-Davidson Resilience Scale (CD-RISC) 10-item self-report measure of resilience; higher scores indicate greater resilience 16 weeks
Secondary Connor-Davidson Resilience Scale (CD-RISC) 10-item self-report measure of resilience; higher scores indicate greater resilience 6 months
Secondary Dyadic Coping Inventory (DCI)-short 11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping baseline
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Zarit Burden Inventory-Short 12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden baseline
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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