MEditation for Post Stroke Depression

Stroke Clinical Trial

— MEND  

Official title:

MEditation for Post Stroke Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239132
• Other study ID #: HSC-SN-17-0583
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: February 19, 2019

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 19, 2019
• Est. primary completion date: February 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Stroke

Intervention

Behavioral:
• Breath-based meditation
The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.
• Meditation educational materials
Meditation educational materials

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by number screened per week		2 years
Primary	Feasibility as assessed by proportion of those eligible who enroll to the study		2 years
Primary	Feasibility as assessed by number of participants who completed the study		2 years
Primary	Feasibility as assessed by number of participants who adhered to the protocol		2 years
Primary	Feasibility as assessed by number of participants who completed all study assessments		2 years
Secondary	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
Secondary	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
Secondary	Levels of plasma IL-1 family pro-inflammatory cytokines		baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends