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Completed

NCT Number: NCT03239132

MEditation for Post Stroke Depression

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.

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Key information

Conditions

Stroke Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breath-based meditation

Behavioral

The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.

Meditation educational materials

Behavioral

Meditation educational materials

Primary outcomes

  1. Feasibility as assessed by number screened per week

    Time frame: 2 years

  2. Feasibility as assessed by proportion of those eligible who enroll to the study

    Time frame: 2 years

  3. Feasibility as assessed by number of participants who completed the study

    Time frame: 2 years

  4. Feasibility as assessed by number of participants who adhered to the protocol

    Time frame: 2 years

  5. Feasibility as assessed by number of participants who completed all study assessments

    Time frame: 2 years

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Acronym: MEND

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2017
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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