Testing a Positive Psychology-based Intervention for Couples Coping With Stroke

Study Overview
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Brief Summary
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This study aims to pilot test an 8-week, self-administered dyadic (couples-based) positive psychology intervention for couples coping with stroke using a randomized, waitlist control design. Mood and well-being will be assessed pre- and post-intervention, and at 3-month follow-up. It is expected that both partners will demonstrate improvement in mood and well-being.

Detailed Description
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Stroke survivors and spousal caregivers face significant challenges, yet interventions to support couples after stroke are largely lacking. Depressive symptoms post-stroke occur in 30-50% of survivors and partner caregivers, and have significant consequences on function and quality of life. Further, mood and psychosocial well-being are reciprocal in couples, meaning if one partner is depressed, the other is more likely to be depressed. Sustaining well-being in both partners is important for continued engagement in rehabilitation and re-integration into the community, yet existing interventions are aimed at the individual rather than the couple. This study will address this gap by testing an innovative dyadic (couples-based) intervention using a new approach based on positive psychology that focuses on the strengths in the relationship in order to foster resilience in the couple. Using a randomized waitlist control design, this pilot study aims to determine whether an 8-week dyadic positive psychology-based intervention (PPI) can improve mood and subjective well-being as assessed by established outcome measures in 24 couples coping with stroke. The intervention consists of self-administered PPI activities, such as expressing gratitude and practicing acts of kindness, which participants complete individually and as a couple. Two potential pathways will be explored for the PPI: (a) enhanced quality of interactions as couples deal with daily life demands and (b) improvements in mood that are contagious among couples. If found effective, couples with greater well-being may be better emotionally equipped to cope with the sequelae of stroke by reducing stress and depressive symptoms, and increasing participation in meaningful activities and quality of life.

Official Title
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Pilot Testing a Positive Psychology-based Intervention for Couples Coping With Stroke: Promoting Resilience After Stroke in Dyads (RESToreD)

Conditions
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Stroke, Depression, Depressive Symptoms, Post-stroke Depression

Intervention / Treatment
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* Behavioral: Dyadic (couples-based) positive psychology intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Couples consist of one partner who had an ischemic or hemorrhagic stroke >3 months ago and a cohabiting partner (> 1 year) who self-identifies as the caregiver and is willing to enroll in the study; Either one or both partner(s) report depressive symptoms as assessed by the PROMIS-D (no formal diagnosis is required). Exclusion Criteria: the caregiver has had a stroke or other major neurological condition; either partner is unable to understand the printed English instructions; either partner scores <19 (the established cut-off for mild cognitive impairment) on the Montreal Cognitive Assessment (MoCA), a validated screening instrument for cognitive performance.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Waitlist control design; participants are assigned to receive intervention or be waitlisted for 4-6 weeks and then receive intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Psychology Intervention<br>Participants complete baseline assessments and receive a 20min training on the positive psychology activities. They are instructed to engage in at least 2 positive psychology activities alone and at least 2 as a couple each week for 8 weeks. Self-administered activities include expressing gratitude, practicing acts of kindness, focusing on the positive, fostering relationships, working toward a goal, spirituality, savoring. Post-intervention and 3-month follow-up assessments are completed. | Behavioral: Dyadic (couples-based) positive psychology intervention<br>* Self-administered behavioral intervention in which participants complete at least 2 activities alone and 2 together each week for 8 weeks. Positive psychology activities include expressing gratitude, practicing acts of kindness, fostering relationships, working toward a goal, focusing on the positive, spirituality, and savoring.<br>|
| Other: Waitlist control<br>Participants complete a baseline assessment and are waitlisted for 4-6 weeks. They then complete another assessment, receive the 20min training on activities, and then complete the 8-week self-administered intervention (same as the experimental arm). Post-intervention and 3-month follow up assessments are also completed. | Behavioral: Dyadic (couples-based) positive psychology intervention<br>* Self-administered behavioral intervention in which participants complete at least 2 activities alone and 2 together each week for 8 weeks. Positive psychology activities include expressing gratitude, practicing acts of kindness, fostering relationships, working toward a goal, focusing on the positive, spirituality, and savoring.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Depression-SF | An 8-item measure of depressive symptoms in which participants rate how they have felt over the past 7 days (e.g., I felt worthless, I felt unhappy) on a 5-point Likert scale from never to always). Higher scores are worse. | Change from baseline to 8 weeks (post-intervention) | 
| NeuroQOL Positive Affect and Wellbeing-SF | A 9-item measure of wellbeing in which participants rate how they have felt lately (e.g., my life had purpose, I felt hopeful) on a 5-point Likert scale from never to always. Higher scores are better | Change from baseline to 8 weeks (post-intervention) | 
| NeuroQOL Positive Affect and Wellbeing-SF | A 9-item measure of wellbeing in which participants rate how they have felt lately (e.g., my life had purpose, I felt hopeful) on a 5-point Likert scale from never to always. Higher scores are better | Change from 8 weeks to 20 weeks (3-months post-intervention) | 
| PROMIS Depression-SF | An 8-item measure of depressive symptoms in which participants rate how they have felt over the past 7 days (e.g., I felt worthless, I felt unhappy) on a 5-point Likert scale from never to always). Higher scores are worse. | Change from 8 weeks to 20 weeks (3-months post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Impact Scale | A 60-item stroke-specific quality of life measure in which participants rate how stroke has impacted them across 8 domains (e.g., strength of affected arm, communication, activities of daily living) on a 5-point Likert scale (not difficult to cannot do at all). Higher scores are better (indicate better quality of life) | Change from baseline to 8 weeks (post-intervention) | 
| Stroke Impact Scale | A 60-item stroke-specific quality of life measure in which participants rate how stroke has impacted them across 8 domains (e.g., strength of affected arm, communication, activities of daily living) on a 5-point Likert scale (not difficult to cannot do at all). Higher scores are better (indicate better quality of life) | Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention) | 
| Positive Affect and Negative Affect Schedule (PANAS) | A measure of positive affect and negative affect; participants rate a list of 20 adjectives that describes them (e.g., afraid or excited) on a 5-point Likert scale from Not at all to Extremely. Scores are summed for two subscales (positive affect, negative affect), and higher scores indicate having more of either positive or negative affect | Change from baseline to 8 weeks (post-intervention) | 
| Positive Affect and Negative Affect Schedule (PANAS) | A measure of positive affect and negative affect; participants rate a list of 20 adjectives that describes them (e.g., afraid or excited) on a 5-point Likert scale from Not at all to Extremely. Scores are summed for two subscales (positive affect, negative affect), and higher scores indicate having more of either positive or negative affect | Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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couples, positive psychology, behavioral intervention, stroke, depression, wellbeing, caregiver