MEND: MEditation for Post Stroke Depression

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT03239132
• Collaborator: (none)
• Enrollment: 71
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.1
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Depression	Behavioral: Breath-based meditation; Behavioral: Meditation educational materials	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: MEditation for Post Stroke Depression
• Actual Study Start Date: Nov 15, 2017
• Actual Primary Completion Date: Feb 19, 2019
• Actual Study Completion Date: Feb 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breath-based meditation 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; The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.; Behavioral: Meditation educational materials; Meditation educational materials
Active Comparator: Control The control will receive meditation educational materials.	Behavioral: Meditation educational materials; Meditation educational materials

Outcome Measures

Primary Outcome Measures

1. Feasibility as assessed by number screened per week [2 years]

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

3. Feasibility as assessed by number of participants who completed the study [2 years]

4. Feasibility as assessed by number of participants who adhered to the protocol [2 years]

5. Feasibility as assessed by number of participants who completed all study assessments [2 years]

Secondary Outcome Measures

1. 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]

2. 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]

3. Levels of plasma IL-1 family pro-inflammatory cytokines [baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Jennifer E Sanner, PhD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer E. Sanner Beauchamp, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03239132
• Other Study ID Numbers: HSC-SN-17-0583
• First Posted: Aug 3, 2017
• Last Update Posted: Jun 12, 2019
• Last Verified: Jun 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Depression; Depressive Disorder

Study Results

No Results Posted as of Jun 12, 2019