MEditation for Post Stroke Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2019-02-19

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.

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Detailed Description

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Conditions

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Stroke Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Breath-based meditation

The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials.

Group Type EXPERIMENTAL

Breath-based meditation

Intervention Type BEHAVIORAL

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

Meditation educational materials

Intervention Type BEHAVIORAL

Meditation educational materials

Control

The control will receive meditation educational materials.

Group Type ACTIVE_COMPARATOR

Meditation educational materials

Intervention Type BEHAVIORAL

Meditation educational materials

Interventions

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Breath-based meditation

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

Intervention Type BEHAVIORAL

Meditation educational materials

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No