MEditation for Post Stroke Depression (MEND)

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 Overview

• Status: Completed
• Conditions: Depression; Stroke
• Intervention / Treatment: Behavioral: Breath-based meditation; Behavioral: Meditation educational materials

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breath-based meditation; 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; The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.; Behavioral: Meditation educational materials; Meditation educational materials
Active Comparator: Control; The control will receive meditation educational materials.	Behavioral: Meditation educational materials; Meditation educational materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Jennifer E Sanner, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): February 19, 2019
• Study Completion (Actual): February 19, 2019

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Stroke; Depression; Depressive Disorder
• Other Study ID Numbers: HSC-SN-17-0583

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No