Stroke Clinical Trial
— ReStoreDOfficial title:
Testing Efficacy of an Intervention to Promote Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)
Affecting nearly 800,000 people in the US every year, stroke is a leading cause of long-term disability, and has serious consequences for stroke survivors and their carepartners. Our project uses a scientifically rigorous efficacy study to evaluate a remotely delivered 8-week dyadic (couples-based) positive psychology intervention to reduce emotional distress in stroke survivors and their carepartners. If successful, couples may be better emotionally equipped to cope with the sequelae of stroke, and have better rehabilitation outcomes and quality of life.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | August 31, 2027 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Community-dwelling cohabitating couple where one partner has a had an ischemic or hemorrhagic stroke - The stroke must have occurred between 3 months and 3 years prior to enrollment - The adult couple must have been living together since before the stroke and for at least 6 months prior to enrollment - One or both partners must report some anxiety and/or depressive symptoms - Participants must be able to read, understand, and follow instructions, and be able to provide their own consent Exclusion Criteria: • Either dyad partner has significant aphasia (difficulties with speech), visual, psychiatric, and/or significant cognitive impairment that would limit their ability to participate in the intervention in a meaningful way |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form | 8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress | Baseline | |
Primary | PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form | 8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress | 8 weeks | |
Primary | PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form | 8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress | 16 weeks | |
Primary | PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form | 8-item self-report measure of depression (4 items) and anxiety (4 items); higher scores indicate more emotional distress | 6 months | |
Secondary | Connor-Davidson Resilience Scale (CD-RISC) | 10-item self-report measure of resilience; higher scores indicate greater resilience | baseline | |
Secondary | Connor-Davidson Resilience Scale (CD-RISC) | 10-item self-report measure of resilience; higher scores indicate greater resilience | 8 weeks | |
Secondary | Connor-Davidson Resilience Scale (CD-RISC) | 10-item self-report measure of resilience; higher scores indicate greater resilience | 16 weeks | |
Secondary | Connor-Davidson Resilience Scale (CD-RISC) | 10-item self-report measure of resilience; higher scores indicate greater resilience | 6 months | |
Secondary | Dyadic Coping Inventory (DCI)-short | 11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping | baseline | |
Secondary | Dyadic Coping Inventory (DCI)-short | 11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping | 8 weeks | |
Secondary | Dyadic Coping Inventory (DCI)-short | 11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping | 16 weeks | |
Secondary | Dyadic Coping Inventory (DCI)-short | 11-item self-report measure of how well the couple copes with stress; higher scores indicate better coping | 6 months | |
Secondary | Dyadic Relationship Scale | Self report measure that assesses care-recipient-caregiver relationship and includes 2 subscales: Dyadic Strain (5 items; higher scores mean more strain) and Positive Dyadic Interactions (6 items; higher scores mean more positive interactions) | baseline | |
Secondary | Dyadic Relationship Scale | Self report measure that assesses care-recipient-caregiver relationship and includes 2 subscales: Dyadic Strain (5 items; higher scores mean more strain) and Positive Dyadic Interactions (6 items; higher scores mean more positive interactions) | 8 weeks | |
Secondary | Dyadic Relationship Scale | Self report measure that assesses care-recipient-caregiver relationship and includes 2 subscales: Dyadic Strain (5 items; higher scores mean more strain) and Positive Dyadic Interactions (6 items; higher scores mean more positive interactions) | 16 weeks | |
Secondary | Dyadic Relationship Scale | Self report measure that assesses care-recipient-caregiver relationship and includes 2 subscales: Dyadic Strain (5 items; higher scores mean more strain) and Positive Dyadic Interactions (6 items; higher scores mean more positive interactions) | 6 months | |
Secondary | PROMIS-Psychosocial Illness Impact Scale-short form | 8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress. | baseline | |
Secondary | PROMIS-Psychosocial Illness Impact Scale-short form | 8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress. | 8 weeks | |
Secondary | PROMIS-Psychosocial Illness Impact Scale-short form | 8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress. | 16 weeks | |
Secondary | PROMIS-Psychosocial Illness Impact Scale-short form | 8-item self report measure on stroke-related stress (completed by person with stroke only); higher scores indicate greater negative impact/more stress. | 6-months | |
Secondary | Zarit Burden Inventory-Short | 12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden | baseline | |
Secondary | Zarit Burden Inventory-Short | 12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden | 8 weeks | |
Secondary | Zarit Burden Inventory-Short | 12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden | 16 weeks | |
Secondary | Zarit Burden Inventory-Short | 12 item self-report measure on caregiving related stress/burden (completed by partner only); higher scores indicate more burden | 6 months | |
Secondary | Meaningful Activity Participation Assessment (MAPA) | 28 activity items are rated on frequency of engaging in these activities (higher score means more frequent) and how meaningful they are to the person (higher score means more meaningful) | baseline | |
Secondary | Meaningful Activity Participation Assessment (MAPA) | 28 activity items are rated on frequency of engaging in these activities (higher score means more frequent) and how meaningful they are to the person (higher score means more meaningful) | 8 weeks | |
Secondary | Meaningful Activity Participation Assessment (MAPA) | 28 activity items are rated on frequency of engaging in these activities (higher score means more frequent) and how meaningful they are to the person (higher score means more meaningful) | 16 weeks | |
Secondary | Meaningful Activity Participation Assessment (MAPA) | 28 activity items are rated on frequency of engaging in these activities (higher score means more frequent) and how meaningful they are to the person (higher score means more meaningful) | 6 months |
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