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

Stroke Clinical Trial

— RESToreD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335358
• Other study ID #: 1R03HD091432-01
• Status: Completed
• Phase: N/A
• Start date: April 14, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Symptoms
• Post-stroke Depression
• Stroke

Intervention

Behavioral:
• Dyadic (couples-based) positive psychology intervention
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.

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, 

References & Publications (1)

Terrill AL, Reblin M, MacKenzie JJ, Cardell B, Einerson J, Berg CA, Majersik JJ, Richards L. Development of a novel positive psychology-based intervention for couples post-stroke. Rehabil Psychol. 2018 Feb;63(1):43-54. doi: 10.1037/rep0000181. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver Strain Index	A 13-item measure of caregiver strain, in which participants respond yes (1 point) or no (0 points) to items including "sleep is disturbed," and "it is inconvenient"; higher scores mean more strain	Change from baseline to 8 weeks (post-intervention)
Other	Caregiver Strain Index	A 13-item measure of caregiver strain, in which participants respond yes (1 point) or no (0 points) to items including "sleep is disturbed," and "it is inconvenient"; higher scores mean more strain	Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
Other	Dyadic Coping Inventory	A 39-item measure of coping for couples in which participants indicate how they (as a couple) cope with stress on a 5-item Likert scale from "very rarely" to "very often". Higher scores indicate better/more adaptive coping	Change from baseline to 8 weeks (post-intervention)
Other	Dyadic Coping Inventory	A 39-item measure of coping for couples in which participants indicate how they (as a couple) cope with stress on a 5-item Likert scale from "very rarely" to "very often". Higher scores indicate better/more adaptive coping	Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)