Automatic Self Transcending Meditation (ASTM) Versus Hear... | NCT01908673

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jul 18, 2013

First Submission Date that Met QC Criteria

Jul 23, 2013

First Posted Date

Jul 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2014

Last Update Posted Date

Feb 26, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Akshya Vasudev, Principal Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background: Depression in the elderly, also known as late life depression (LLD) is common and its prevalence ranges from 2 to 6% in the community. Heart Rate Variability (HRV), a physiological autonomic variable is reduced in LLD and this might have implications for cardiovascular events including death. Methods to improve HRV in LLD have not been adequately assessed. Automatic Self-Transcending Meditation (ASTM) is a simple yet powerful technique that allows the mind to become calm and peaceful. HRV biofeedback is a method of teaching individuals to voluntarily improve HRV and other physiological functions to a prescribed range.This pilot study attempts to investigate feasibility of these interventions and provide preliminary data regarding the effectiveness of these techniques.

Hypothesis: ASTM and HRV biofeedback are feasible and their effectiveness for improving HRV in patients with LLD can be assessed.

Methods: Participants with LLD between the ages of 66 and 80 will be randomized to either ASTM or HRV biofeedback after optimizing them on antidepressant therapy. Participants will receive training and continue practice in either of these techniques over a period of twelve weeks. HRV and secondary measures will be assessed pre and post at the end of study period.

Expected Results and Significance: The investigators expect to find both techniques to be feasible treatments for those with LLD. Results from this pilot study will help to assess the potential for successful implementation of a future larger study which will evaluate the efficacy of these treatments for improving HRV.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HRV biofeedback	Active Comparator	heart rate variability biofeedback	Behavioral: HRV biofeedback
ASTM	Active Comparator	Automatic Self Transcedental Meditation	Behavioral: ASTM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HRV biofeedback	Behavioral		HRV biofeedback
ASTM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Heart Rate Variability (HRV)	HRV will be assessed at baseline and at end of study period (week 12)	Week 0 and week 12

Secondary Outcomes

Measure	Description	Time Frame
Change in depression severity	Depression symptoms will be assessed on the Hamilton depression rating scale (HAM-D, 24 items), Clinical Global Impression (CGI), and self-rated Geriatric Depression Scale (GDS)	week 0 and week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Of either gender, age 66-80 years.
Have an Axis 1 diagnosis of major depressive disorder (DSM IV code 296.2x or 296.3x) (comorbid anxiety and dysthymic disorder will be acceptable).
HAMD-24 score of >20.
Low risk of suicide as elicited by clinical interview.
Being able to sit for 30-45 minutes, without physical pain
Of general good physical health with no severe cardiovascular disease in the past 12 months (myocardial infarction, stroke or TIA).
No past history of neurological disease or seizures.
Sufficient hearing to comprehend verbal instructions without the need to lip read.
Able to attend regular outpatient follow-up appointments.

Exclusion Criteria:

Incapable of giving informed consent to study participation.
Participating in other similar studies.
Other significant Axis I diagnosis (including PTSD, OCD, Panic Disorder, Bipolar Affective Disorder, Substance dependence, Dementia)
Psychotic episodes within the past 12 months.
Recent (within the past 6 months) head trauma that required emergency care
Currently on an antidepressant from the classes of Tricyclic antidepressants, Monoamine oxidase (MAO) inhibitors, or Serotonin Noradrenaline Reuptake inhibitors (SNRI) such as venlafaxine, desvenlafaxine or duloxetine.
Currently practicing any type of formal meditation, mindfulness or breathing techniques.
Mini Mental Score Exam (MMSE) ≤18

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

66 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided