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Completed

NCT Number: NCT03335358

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

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.

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Key information

Conditions

Stroke Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Depressive Symptoms Nervous System Diseases Post-stroke Depression Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dyadic (couples-based) positive psychology intervention

Behavioral

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 outcomes

  1. 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.

  2. 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

  3. 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

  4. 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 outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Acronym: RESToreD

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2017
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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