Clinical trial NCT03335358: Testing a Positive Psychology-based Intervention for Couples Coping With Stroke
Official title: Pilot Testing a Positive Psychology-based Intervention for Couples Coping With Stroke: Promoting Resilience After Stroke in Dyads (RESToreD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Depression
Depressive Symptoms
Post-stroke Depression
Keywords: couples
positive psychology
behavioral intervention
stroke
depression
wellbeing
caregiver
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Waitlist control design; participants are assigned to receive intervention or be waitlisted for 4-6 weeks and then receive intervention.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PROMIS Depression-SF
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: NeuroQOL Positive Affect and Wellbeing-SF
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: NeuroQOL Positive Affect and Wellbeing-SF
timeFrame: Change from 8 weeks to 20 weeks (3-months post-intervention)
measure: PROMIS Depression-SF
timeFrame: Change from 8 weeks to 20 weeks (3-months post-intervention)
Secondary outcomes:
measure: Stroke Impact Scale
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Stroke Impact Scale
timeFrame: Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
measure: Positive Affect and Negative Affect Schedule (PANAS)
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Positive Affect and Negative Affect Schedule (PANAS)
timeFrame: Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
Other outcomes:
measure: Caregiver Strain Index
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Caregiver Strain Index
timeFrame: Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
measure: Dyadic Coping Inventory
timeFrame: Change from baseline to 8 weeks (post-intervention)
measure: Dyadic Coping Inventory
timeFrame: Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Alexandra L Terrill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.