StrokeRESToreDNCT03335358
Testing a Positive Psychology-based Intervention for Couples Coping With Stroke
A study testing Dyadic (couples-based) positive psychology intervention in people with Stroke and Depression, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Depression, Depressive Symptoms
- What is being tested?
- Dyadic (couples-based) positive psychology intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2017to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Testing a Positive Psychology-based Intervention for Couples Coping With Stroke: Promoting Resilience After Stroke in Dyads (RESToreD)
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.
Read the 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.
- Conditions
- Stroke, Depression, Depressive Symptoms, Post-stroke Depression
- Being tested
- Dyadic (couples-based) positive psychology intervention
- Keywords
- couples, positive psychology, behavioral intervention, stroke, depression, wellbeing, caregiver
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic (couples-based) positive psychology interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology Intervention | Experimental | 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. Receives: Behavioral: Dyadic (couples-based) positive psychology intervention |
| Waitlist control | Other | 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. Receives: Behavioral: Dyadic (couples-based) positive psychology intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 8 weeks (post-intervention)
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
Measured: Change from baseline to 8 weeks (post-intervention)
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
Measured: Change from 8 weeks to 20 weeks (3-months post-intervention)
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.
Measured: Change from 8 weeks to 20 weeks (3-months post-intervention)
Secondary outcomes (4)
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)
Measured: Change from baseline to 8 weeks (post-intervention)
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)
Measured: Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
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
Measured: Change from baseline to 8 weeks (post-intervention)
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
Measured: Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start14 Apr 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Waitlist control design; participants are assigned to receive intervention or be waitlisted for 4-6 weeks and then receive intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Terrill, University of Utah
- Investigators
- Alexandra L Terrill, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335358
- Sponsor's protocol ID
- 1R03HD091432-01
- Acronym
- RESToreD
- Status last verified
- May 2020
- First submitted
- 24 Oct 2017
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 29553781Terrill 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.
PubMed 37075965Einerson 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.
PubMed 35914538Niermeyer 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.
PubMed 35377699Terrill 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.
PubMed 35162827Anderson 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.
PubMed 34228090
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing a Positive Psychology-based Intervention for Couples Coping With Stroke: Promoting Resilience After Stroke in Dyads (RESToreD)
- ClinicalTrials.gov ID
- NCT03335358
- Acronym / sponsor ID
- RESToreD / 1R03HD091432-01
- Conditions
- Stroke, Depression, Depressive Symptoms, Post-stroke Depression
- Keywords
- couples, positive psychology, behavioral intervention, stroke, depression, wellbeing, caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Waitlist control design; participants are assigned to receive intervention or be waitlisted for 4-6 weeks and then receive intervention.
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology Intervention | Experimental | Behavioral: Dyadic (couples-based) positive psychology interventionParticipants 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. |
| Waitlist control | Other | Behavioral: Dyadic (couples-based) positive psychology interventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic (couples-based) positive psychology interventionSelf-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. | Behavioural | Positive Psychology Intervention, Waitlist control |
Primary outcome
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.
4 secondary outcomes
Stroke Impact Scale
Time frame: Change from baseline to 8 weeks (post-intervention)
Stroke Impact Scale
Time frame: Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
Positive Affect and Negative Affect Schedule (PANAS)
Time frame: Change from baseline to 8 weeks (post-intervention)
Positive Affect and Negative Affect Schedule (PANAS)
Time frame: Change from 8 weeks (post-intervention) to 20 weeks (3-months post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Results publication: PubMed 29553781Terrill 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.
- Derived from this study: PubMed 37075965Terrill 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.
- Derived from this study: PubMed 35914538Einerson 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.
- Derived from this study: PubMed 35377699Niermeyer 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.
- Derived from this study: PubMed 35162827Terrill 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.
- Derived from this study: PubMed 34228090Anderson 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra L Terrill, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic (couples-based) positive psychology intervention in people with Stroke and Depression, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Depression-SF (time frame: Change from baseline to 8 weeks (post-intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03335358, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020; AzTrials last refreshed its copy on 28 Oct 2026.