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The purpose of this study is to establish the feasibility and acceptability of a breath-based meditation in stroke survivors with post-stroke depression (PSD) and their informal caregivers, as well as to examine the effects of the breath-based meditation. The hypothesis is that the breath-based meditation will lead to decreases in the severity of symptoms of PSD, post-stroke anxiety (PSA), and post-traumatic stress disorder (PTSD), and decreases in plasma IL-1 pro-inflammatory cytokines post-intervention in stroke survivors with PSD and their informal caregivers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breath-based meditation | Experimental | The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials. |
|
| Control | Active Comparator | The control will receive meditation educational materials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath-based meditation | Behavioral | The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as assessed by number screened per week | 2 years | |
| Feasibility as assessed by proportion of those eligible who enroll to the study | 2 years | |
| Feasibility as assessed by number of participants who completed the study | 2 years | |
| Feasibility as assessed by number of participants who adhered to the protocol | 2 years | |
| Feasibility as assessed by number of participants who completed all study assessments | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Stroke Depression as assessed by the Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10) | baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends | |
| Post-Stroke Anxiety as assessed by the State-Trait Anxiety Inventory for Adults (STAI-AD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer E Sanner, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36635775 | Derived | Beauchamp JES, Sharrief A, Chaoul A, Casameni Montiel T, Love MF, Cron S, Prossin A, Selvaraj S, Dishman D, Savitz SI. Feasibility of a meditation intervention for stroke survivors and informal caregivers: a randomized controlled trial. BMC Psychol. 2023 Jan 12;11(1):9. doi: 10.1186/s40359-022-01031-z. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003863 | Depression |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Meditation educational materials | Behavioral | Meditation educational materials |
|
| baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends |
| Levels of plasma IL-1 family pro-inflammatory cytokines | baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |