Back to resultsMEditation for Post Stroke Depression (MEND)
Primary Purpose
Stroke, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breath-based meditation
Meditation educational materials
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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.
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Breath-based meditation
Control
Arm Description
The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials.
The control will receive meditation educational materials.
Outcomes
Primary Outcome Measures
Feasibility as assessed by number screened per week
Feasibility as assessed by proportion of those eligible who enroll to the study
Feasibility as assessed by number of participants who completed the study
Feasibility as assessed by number of participants who adhered to the protocol
Feasibility as assessed by number of participants who completed all study assessments
Secondary Outcome Measures
Post-Stroke Depression as assessed by the Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10)
Post-Stroke Anxiety as assessed by the State-Trait Anxiety Inventory for Adults (STAI-AD)
Levels of plasma IL-1 family pro-inflammatory cytokines
Full Information
NCT ID
NCT03239132
First Posted
August 1, 2017
Last Updated
May 31, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03239132
Brief Title
MEditation for Post Stroke Depression
Acronym
MEND
Official Title
MEditation for Post Stroke Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
February 19, 2019 (Actual)
Study Completion Date
February 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breath-based meditation
Arm Type
Experimental
Arm Description
The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control will receive meditation educational materials.
Intervention Type
Behavioral
Intervention Name(s)
Breath-based meditation
Intervention Description
The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Meditation educational materials
Intervention Description
Meditation educational materials
Primary Outcome Measure Information:
Title
Feasibility as assessed by number screened per week
Time Frame
2 years
Title
Feasibility as assessed by proportion of those eligible who enroll to the study
Time Frame
2 years
Title
Feasibility as assessed by number of participants who completed the study
Time Frame
2 years
Title
Feasibility as assessed by number of participants who adhered to the protocol
Time Frame
2 years
Title
Feasibility as assessed by number of participants who completed all study assessments
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer E Sanner, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MEditation for Post Stroke Depression
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