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

Primary Purpose

Stroke, Depression, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dyadic (couples-based) positive psychology intervention
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring couples, positive psychology, behavioral intervention, stroke, depression, wellbeing, caregiver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Positive Psychology Intervention

Waitlist control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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
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
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.

Secondary Outcome Measures

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)
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)
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
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

Full Information

First Posted
October 24, 2017
Last Updated
May 15, 2020
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03335358
Brief Title
Testing a Positive Psychology-based Intervention for Couples Coping With Stroke
Acronym
RESToreD
Official Title
Pilot Testing a Positive Psychology-based Intervention for Couples Coping With Stroke: Promoting Resilience After Stroke in Dyads (RESToreD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 14, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Depression, Depressive Symptoms, Post-stroke Depression
Keywords
couples, positive psychology, behavioral intervention, stroke, depression, wellbeing, caregiver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Waitlist control design; participants are assigned to receive intervention or be waitlisted for 4-6 weeks and then receive intervention.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Psychology Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dyadic (couples-based) positive psychology intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
PROMIS Depression-SF
Description
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.
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
NeuroQOL Positive Affect and Wellbeing-SF
Description
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
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
NeuroQOL Positive Affect and Wellbeing-SF
Description
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
Time Frame
Change from 8 weeks to 20 weeks (3-months post-intervention)
Title
PROMIS Depression-SF
Description
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.
Time Frame
Change from 8 weeks to 20 weeks (3-months post-intervention)
Secondary Outcome Measure Information:
Title
Stroke Impact Scale
Description
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)
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Stroke Impact Scale
Description
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)
Time Frame
Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
Title
Positive Affect and Negative Affect Schedule (PANAS)
Description
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
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Positive Affect and Negative Affect Schedule (PANAS)
Description
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
Time Frame
Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
Other Pre-specified Outcome Measures:
Title
Caregiver Strain Index
Description
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
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Caregiver Strain Index
Description
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
Time Frame
Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
Title
Dyadic Coping Inventory
Description
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
Time Frame
Change from baseline to 8 weeks (post-intervention)
Title
Dyadic Coping Inventory
Description
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
Time Frame
Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
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

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified individual participant data for all outcome measures will be made available. The data will be made available within 1 year of study completion. Access requests will be reviewed, and a data access agreement is required.
Citations:
PubMed Identifier
29553781
Citation
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.
Results Reference
result
PubMed Identifier
35377699
Citation
Niermeyer M, Einerson J, Terrill AL. Perceptions of function and recovery among persons with stroke and care partners. Rehabil Psychol. 2022 May;67(2):215-225. doi: 10.1037/rep0000441. Epub 2022 Apr 4.
Results Reference
derived
PubMed Identifier
35162827
Citation
Terrill AL, Reblin M, MacKenzie JJ, Baucom BRW, Einerson J, Cardell B, Richards LG, Majersik JJ. Intimate Relationships and Stroke: Piloting a Dyadic Intervention to Improve Depression. Int J Environ Res Public Health. 2022 Feb 5;19(3):1804. doi: 10.3390/ijerph19031804.
Results Reference
derived
PubMed Identifier
34228090
Citation
Anderson MA, Buffo C, Ketcher D, Nguyen H, MacKenzie JJ, Reblin M, Terrill AL. Applying the RISE Model of Resilience in Partners Post-Stroke: A Qualitative Analysis. Ann Behav Med. 2022 Mar 1;56(3):270-281. doi: 10.1093/abm/kaab053.
Results Reference
derived

Learn more about this trial

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

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