Clinical trial NCT03239132: MEditation for Post Stroke Depression
Official title: MEditation for Post Stroke Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Depression
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility as assessed by number screened per week
timeFrame: 2 years
measure: Feasibility as assessed by proportion of those eligible who enroll to the study
timeFrame: 2 years
measure: Feasibility as assessed by number of participants who completed the study
timeFrame: 2 years
measure: Feasibility as assessed by number of participants who adhered to the protocol
timeFrame: 2 years
measure: Feasibility as assessed by number of participants who completed all study assessments
timeFrame: 2 years
Secondary outcomes:
measure: Post-Stroke Depression as assessed by the Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10)
timeFrame: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
measure: Post-Stroke Anxiety as assessed by the State-Trait Anxiety Inventory for Adults (STAI-AD)
timeFrame: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
measure: Levels of plasma IL-1 family pro-inflammatory cytokines
timeFrame: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jennifer E Sanner, PhD
role: PRINCIPAL_INVESTIGATOR
References: