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

This study is currently recruiting participants.
Verified November 2017 by Alexandra Terrill, University of Utah
Sponsor:
ClinicalTrials.gov Identifier:
NCT03335358
First Posted: November 7, 2017
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alexandra Terrill, University of Utah
  Purpose
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.

Condition Intervention
Stroke Depression Depressive Symptoms Post-stroke Depression Behavioral: Dyadic (couples-based) positive psychology intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Waitlist control design; participants are assigned to receive intervention or be waitlisted for 4-6 weeks and then receive intervention.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Testing a Positive Psychology-based Intervention for Couples Coping With Stroke: Promoting Resilience After Stroke in Dyads (RESToreD)

Further study details as provided by Alexandra Terrill, University of Utah:

Primary Outcome Measures:
  • PROMIS Depression-SF [ Time Frame: Change from baseline to 8 weeks (post-intervention) ]
    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 [ Time Frame: Change from baseline to 8 weeks (post-intervention) ]
    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 [ Time Frame: Change from 8 weeks to 20 weeks (3-months post-intervention) ]
    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 [ Time Frame: Change from 8 weeks to 20 weeks (3-months post-intervention) ]
    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 [ Time Frame: Change from baseline to 8 weeks (post-intervention) ]
    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 [ Time Frame: Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention) ]
    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) [ Time Frame: Change from baseline to 8 weeks (post-intervention) ]
    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) [ Time Frame: Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention) ]
    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


Other Outcome Measures:
  • Caregiver Strain Index [ Time Frame: Change from baseline to 8 weeks (post-intervention) ]
    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

  • Caregiver Strain Index [ Time Frame: Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention) ]
    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

  • Dyadic Coping Inventory [ Time Frame: Change from baseline to 8 weeks (post-intervention) ]
    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

  • Dyadic Coping Inventory [ Time Frame: Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention) ]
    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


Estimated Enrollment: 70
Actual Study Start Date: April 14, 2017
Estimated Study Completion Date: April 13, 2019
Estimated Primary Completion Date: April 13, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Positive Psychology Intervention
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
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.
Waitlist control
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
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Couples consist of one partner who had an ischemic or hemorrhagic stroke > 6 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335358


Contacts
Contact: Alexandra L Terrill, PhD 801-581-5951 alex.terrill@hsc.utah.edu
Contact: Lorie G Richards, PhD 801-585-1069 lorie.richards@hsc.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Alexandra L Terrill, PhD    801-581-5951    alex.terrill@hsc.utah.edu   
Contact: Jennifer Majersik, MD, MS    801-585-7575    jennifer.majersik@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Alexandra L Terrill, PhD University of Utah
  Study Documents (Full-Text)

Documents provided by Alexandra Terrill, University of Utah:
  More Information

Responsible Party: Alexandra Terrill, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03335358     History of Changes
Other Study ID Numbers: 1R03HD091432-01 ( U.S. NIH Grant/Contract )
First Submitted: October 24, 2017
First Posted: November 7, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexandra Terrill, University of Utah:
couples
positive psychology
behavioral intervention
stroke
depression
wellbeing
caregiver

Additional relevant MeSH terms:
Stroke
Depression
Depressive Disorder
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders