MEditation for Post Stroke Depression

The University of Texas Health Science Center, Houston71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke Depression

Interventions

Breath-based meditationBEHAVIORAL

The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.

Meditation educational materialsBEHAVIORAL

Meditation educational materials

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Feasibility as assessed by number screened per week

Time frame: 2 years

Feasibility as assessed by proportion of those eligible who enroll to the study

Time frame: 2 years

Feasibility as assessed by number of participants who completed the study

Time frame: 2 years

Feasibility as assessed by number of participants who adhered to the protocol

Time frame: 2 years

Feasibility as assessed by number of participants who completed all study assessments

Time frame: 2 years

Secondary Outcomes

Post-Stroke Depression as assessed by the Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10)

Time frame: 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)

Time frame: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends

Levels of plasma IL-1 family pro-inflammatory cytokines

Time frame: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends

Data from ClinicalTrials.gov

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