MEditation for Post Stroke Depression

Not Applicable

Completed

• Conditions: Depression; Stroke
• Interventions: Behavioral: Meditation educational materials; Behavioral: Breath-based meditation

• Registration Number: NCT03239132
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-03
• Study Start: 2017-11-15
• Primary Completion: 2019-02-19
• Study Completion: 2019-02-19
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Meditation educational materials	The control will receive meditation educational materials.
Breath-based meditation	Meditation educational materials	The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials.
Breath-based meditation	Breath-based meditation	The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials.

Primary Outcome Measures

Name	Time	Method
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
Feasibility as assessed by proportion of those eligible who enroll to the study	2 years
Feasibility as assessed by number screened per week	2 years
Feasibility as assessed by number of participants who completed the study	2 years

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States