Promoting Resilience in Stroke Survivor-carepartner Dyads (ReStoreD) (ReStoreD)
Primary Purpose
Stroke, Depression, Anxiety, Coping Skills
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReStoreD
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke
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
Sites / Locations
- University of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ReStoreD
Waitlist-control
Arm Description
8-week intervention that is remotely delivered, consisting of psychoeducation and positive psychology activities. Participants complete two activities individually and two together each week.
Participants will be waitlisted for 8 weeks.
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Connor-Davidson Resilience Scale (CD-RISC)
10-item self-report measure of resilience; higher scores indicate greater resilience
Connor-Davidson Resilience Scale (CD-RISC)
10-item self-report measure of resilience; higher scores indicate greater resilience
Connor-Davidson Resilience Scale (CD-RISC)
10-item self-report measure of resilience; higher scores indicate greater resilience
Connor-Davidson Resilience Scale (CD-RISC)
10-item self-report measure of resilience; higher scores indicate greater resilience
Dyadic Coping Inventory (DCI)-short
11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping
Dyadic Coping Inventory (DCI)-short
11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping
Dyadic Coping Inventory (DCI)-short
11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping
Dyadic Coping Inventory (DCI)-short
11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping
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)
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)
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)
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)
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.
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.
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.
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.
Zarit Burden Inventory-Short
12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden
Zarit Burden Inventory-Short
12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden
Zarit Burden Inventory-Short
12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden
Zarit Burden Inventory-Short
12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden
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)
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)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04845542
Brief Title
Promoting Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)
Acronym
ReStoreD
Official Title
Testing Efficacy of an Intervention to Promote Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Depression, Anxiety, Coping Skills, Couples
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized waitlist control design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ReStoreD
Arm Type
Experimental
Arm Description
8-week intervention that is remotely delivered, consisting of psychoeducation and positive psychology activities. Participants complete two activities individually and two together each week.
Arm Title
Waitlist-control
Arm Type
No Intervention
Arm Description
Participants will be waitlisted for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
ReStoreD
Intervention Description
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.
Primary Outcome Measure Information:
Title
PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form
Description
8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress
Time Frame
Baseline
Title
PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form
Description
8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress
Time Frame
8 weeks
Title
PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form
Description
8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress
Time Frame
16 weeks
Title
PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form
Description
8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Connor-Davidson Resilience Scale (CD-RISC)
Description
10-item self-report measure of resilience; higher scores indicate greater resilience
Time Frame
baseline
Title
Connor-Davidson Resilience Scale (CD-RISC)
Description
10-item self-report measure of resilience; higher scores indicate greater resilience
Time Frame
8 weeks
Title
Connor-Davidson Resilience Scale (CD-RISC)
Description
10-item self-report measure of resilience; higher scores indicate greater resilience
Time Frame
16 weeks
Title
Connor-Davidson Resilience Scale (CD-RISC)
Description
10-item self-report measure of resilience; higher scores indicate greater resilience
Time Frame
6 months
Title
Dyadic Coping Inventory (DCI)-short
Description
11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping
Time Frame
baseline
Title
Dyadic Coping Inventory (DCI)-short
Description
11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping
Time Frame
8 weeks
Title
Dyadic Coping Inventory (DCI)-short
Description
11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping
Time Frame
16 weeks
Title
Dyadic Coping Inventory (DCI)-short
Description
11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping
Time Frame
6 months
Title
Dyadic Relationship Scale
Description
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
Title
Dyadic Relationship Scale
Description
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
Title
Dyadic Relationship Scale
Description
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
Title
Dyadic Relationship Scale
Description
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
Title
PROMIS-Psychosocial Illness Impact Scale-short form
Description
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
Title
PROMIS-Psychosocial Illness Impact Scale-short form
Description
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
Title
PROMIS-Psychosocial Illness Impact Scale-short form
Description
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
Title
PROMIS-Psychosocial Illness Impact Scale-short form
Description
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
Title
Zarit Burden Inventory-Short
Description
12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden
Time Frame
baseline
Title
Zarit Burden Inventory-Short
Description
12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden
Time Frame
8 weeks
Title
Zarit Burden Inventory-Short
Description
12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden
Time Frame
16 weeks
Title
Zarit Burden Inventory-Short
Description
12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden
Time Frame
6 months
Title
Meaningful Activity Participation Assessment (MAPA)
Description
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
Title
Meaningful Activity Participation Assessment (MAPA)
Description
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
Title
Meaningful Activity Participation Assessment (MAPA)
Description
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
Title
Meaningful Activity Participation Assessment (MAPA)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra L Terrill, PhD
Phone
8015815951
Email
alex.terrill@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lorie Richards, PhD, OTR/L
Phone
8015851069
Email
lorie.richards@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra L Terrill, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra L Terrill, PhD
Phone
801-581-5951
Email
alex.terrill@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Majersik, MD, MS
Phone
801-585-7575
Email
jennifer.majersik@hsc.utah.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Promoting Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)
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