Promoting Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)

Stroke Clinical Trial

— ReStoreD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04845542
• Other study ID #: 1R01HD105718-01
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Coping Skills
• Couples
• Depression, Anxiety
• Stroke

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