MEditation for Post Stroke Depression

NCT03239132 | Completed

• 1 other identifier: HSC-SN-17-0583
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Depression

Outcome Measures

Primary Outcomes (5)

• Feasibility as assessed by number screened per week

  2 years

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

  2 years

• Feasibility as assessed by number of participants who completed the study

  2 years

• 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

Secondary Outcomes (3)

• 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

• 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

Study Arms (2)

Breath-based meditation

EXPERIMENTAL

The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials.

Behavioral: Breath-based meditation; Behavioral: Meditation educational materials

Control

ACTIVE COMPARATOR

The control will receive meditation educational materials.

Behavioral: Meditation educational materials

Interventions

Breath-based meditation BEHAVIORAL

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

Breath-based meditation

Meditation educational materials BEHAVIORAL

Meditation educational materials

Breath-based meditation; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Beauchamp JES, Sharrief A, Chaoul A, Casameni Montiel T, Love MF, Cron S, Prossin A, Selvaraj S, Dishman D, Savitz SI. Feasibility of a meditation intervention for stroke survivors and informal caregivers: a randomized controlled trial. BMC Psychol. 2023 Jan 12;11(1):9. doi: 10.1186/s40359-022-01031-z.

  PMID: 36635775 DERIVED

MeSH Terms

Conditions

Stroke; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• Jennifer E Sanner, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: November 15, 2017
• Primary Completion: February 19, 2019
• Study Completion: February 19, 2019
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

US (1)