MEditation for Post Stroke Depression "MEND"

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Breath-based meditation Behavioral
    Intervention Desc: The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.
    ARM 1: Kind: Experimental
    Label: Breath-based meditation
    Description: The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials.
  • Meditation educational materials Behavioral
    Intervention Desc: Meditation educational materials
    ARM 1: Kind: Experimental
    Label: Breath-based meditation
    Description: The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials.
    ARM 2: Kind: Experimental
    Label: Control
    Description: The control will receive meditation educational materials.

Outcomes

Type Measure 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

Sponsors