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

NCT ID: NCT03335358

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-14

Study Completion Date

2020-03-31

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.

Conditions

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Stroke Depression Depressive Symptoms Post-stroke Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Waitlist control design; participants are assigned to receive intervention or be waitlisted for 4-6 weeks and then receive intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dyadic (couples-based) positive psychology intervention

Intervention Type 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.

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.

Group Type OTHER

Dyadic (couples-based) positive psychology intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Terrill

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandra L Terrill, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 29553781 (View on PubMed)

Terrill AL, Reblin M, MacKenzie JJ, Baucom BRW, Einerson J, Cardell B, Richards L, Majersik JJ. Promoting Resilience After Stroke in Dyads (ReStoreD): A Supplemental Analysis. Arch Phys Med Rehabil. 2023 Oct;104(10):1580-1587. doi: 10.1016/j.apmr.2023.03.024. Epub 2023 Apr 17.

Reference Type DERIVED
PMID: 37075965 (View on PubMed)

Einerson J, Lundstrom LK, Allen BK, Sefandonakis A, Terrill AL. Learning to flourish in a new reality: a thematic analysis of couples' experience of participation in a positive psychology intervention post-stroke. Disabil Rehabil. 2023 Aug;45(16):2612-2619. doi: 10.1080/09638288.2022.2102256. Epub 2022 Aug 1.

Reference Type DERIVED
PMID: 35914538 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35377699 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35162827 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34228090 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R03HD091432-01

Identifier Type: NIH

Identifier Source: org_study_id

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