- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03239132
MEditation for Post Stroke Depression (MEND)
May 31, 2023 updated by: Jennifer Beauchamp, The University of Texas Health Science Center, Houston
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
|
The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.
Meditation educational materials
|
Active Comparator: Control
The control will receive 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
Time Frame: 2 years
|
2 years
|
Feasibility as assessed by proportion of those eligible who enroll to the study
Time Frame: 2 years
|
2 years
|
Feasibility as assessed by number of participants who completed the study
Time Frame: 2 years
|
2 years
|
Feasibility as assessed by number of participants who adhered to the protocol
Time Frame: 2 years
|
2 years
|
Feasibility as assessed by number of participants who completed all study assessments
Time Frame: 2 years
|
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)
Time Frame: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
|
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
|
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
|
baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer E Sanner, PhD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Lawson Health Research InstituteTerminated
Clinical Trials on Breath-based meditation
-
Aysegul KilicliRecruitingPreeclampsia | Mindfulness Breath Awareness MeditationTurkey
-
Emory UniversityUniversity of PittsburghCompletedPost Traumatic Stress DisorderUnited States
-
University of Wisconsin, MadisonCompleted
-
University of Alabama at BirminghamM.D. Anderson Cancer CenterActive, not recruitingStress | Stress, Psychological | Anxiety | Stress, Physiological | Happiness | Resilience | Mental Well BeingUnited States
-
Canterbury Christ Church UniversityCompleted
-
Dana-Farber Cancer InstituteCompletedStress | Anxiety | OncologyUnited States
-
Weill Medical College of Cornell UniversityAvon FoundationCompletedBreast CancerUnited States
-
Weill Medical College of Cornell UniversityAvon FoundationCompletedGynecologic Cancer | Breast CancersUnited States
-
Centre for Addiction and Mental HealthActive, not recruitingMental DisorderCanada