MEditation for Post Stroke Depression

Study Overview
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Brief Summary
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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.

Official Title
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MEditation for Post Stroke Depression

Conditions
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Stroke, Depression

Intervention / Treatment
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* Behavioral: Breath-based meditation
* Behavioral: Meditation educational materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stroke survivors will be included if they speak English, can provide written informed consent, have a history of ischemic stroke, hemorrhagic, or transient ischemic attack within the past 8 weeks, have a Center for Epidemiologic Studies-Depression (CES-D) total score of 16 or greater suggestive of clinically significant depressive symptoms, and currently live at home. Informal caregivers will be included if they are speak English, can provide written informed consent, and self-identify as a first-time informal caregiver of a stroke survivor. - To reflect standard practice, stroke survivors and their informal caregivers will be eligible to participate in the study regardless of whether they are currently receiving anti-depressant medications; however, the dose must have been stable for at least one month prior to recruitment into the study. Exclusion Criteria: Stroke survivors will be excluded if they currently reside outside of the home (e.g., rehabilitation center). Stroke survivors and their informal caregivers will be excluded if they have severe cognitive impairment (Montreal Cognitive Assessment (MoCA) cutoff score of 20), active psychosis, or bipolar disorder; if they currently abuse substances; or if they are acutely suicidal. Those currently receiving formal psychotherapy or currently engaging in self-identified meditation practices will also be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breath-based meditation<br>The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials. | Behavioral: Breath-based meditation<br>* The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.<br>Behavioral: Meditation educational materials<br>* Meditation educational materials<br>|
| Active Comparator: Control<br>The control will receive meditation educational materials. | Behavioral: Meditation educational materials<br>* Meditation educational materials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |