MEditation for Post Stroke Depression (MEND)

The University of Texas System (UT)

Status: Completed

Conditions: Stroke; Depression

Treatments: Behavioral: Breath-based meditation; Behavioral: Meditation educational materials

Study type: Interventional

Funder types: Other

Identifiers

NCT03239132

HSC-SN-17-0583

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

Breath-based meditation

Experimental group

Description:

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

Treatment:

Behavioral: Breath-based meditation

Behavioral: Meditation educational materials

Control

Active Comparator group

Description:

The control will receive meditation educational materials.

Treatment:

Behavioral: Meditation educational materials