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Automatic Self Transcending Meditation (ASTM) Versus Heart Rate Variability (HRV) Biofeedback in Patients With Late Life Depression (LLD): a Longitudinal Pilot Feasibility Study

Primary Purpose

Late Life Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HRV biofeedback
ASTM
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Late Life Depression focused on measuring heart rate variability biofeedback, automatic self transcedental meditation

Eligibility Criteria

66 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Of either gender, age 66-80 years.
  2. 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).
  3. HAMD-24 score of >20.
  4. Low risk of suicide as elicited by clinical interview.
  5. Being able to sit for 30-45 minutes, without physical pain
  6. Of general good physical health with no severe cardiovascular disease in the past 12 months (myocardial infarction, stroke or TIA).
  7. No past history of neurological disease or seizures.
  8. Sufficient hearing to comprehend verbal instructions without the need to lip read.
  9. Able to attend regular outpatient follow-up appointments.

Exclusion Criteria:

  1. Incapable of giving informed consent to study participation.
  2. Participating in other similar studies.
  3. Other significant Axis I diagnosis (including PTSD, OCD, Panic Disorder, Bipolar Affective Disorder, Substance dependence, Dementia)
  4. Psychotic episodes within the past 12 months.
  5. Recent (within the past 6 months) head trauma that required emergency care
  6. 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.
  7. Currently practicing any type of formal meditation, mindfulness or breathing techniques.
  8. Mini Mental Score Exam (MMSE) ≤18

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HRV biofeedback

ASTM

Arm Description

heart rate variability biofeedback

Automatic Self Transcedental Meditation

Outcomes

Primary Outcome Measures

Change in Heart Rate Variability (HRV)
HRV will be assessed at baseline and at end of study period (week 12)

Secondary Outcome Measures

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)

Full Information

First Posted
July 18, 2013
Last Updated
February 25, 2014
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01908673
Brief Title
Automatic Self Transcending Meditation (ASTM) Versus Heart Rate Variability (HRV) Biofeedback in Patients With Late Life Depression (LLD): a Longitudinal Pilot Feasibility Study
Official Title
Automatic Self Transcending Meditation (ASTM) Versus Heart Rate Variability (HRV) Biofeedback in Patients With Late Life Depression (LLD): a Randomized Controlled Longitudinal Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Late Life Depression
Keywords
heart rate variability biofeedback, automatic self transcedental meditation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HRV biofeedback
Arm Type
Active Comparator
Arm Description
heart rate variability biofeedback
Arm Title
ASTM
Arm Type
Active Comparator
Arm Description
Automatic Self Transcedental Meditation
Intervention Type
Behavioral
Intervention Name(s)
HRV biofeedback
Intervention Type
Behavioral
Intervention Name(s)
ASTM
Other Intervention Name(s)
Automatic Self Transcedental Meditation
Primary Outcome Measure Information:
Title
Change in Heart Rate Variability (HRV)
Description
HRV will be assessed at baseline and at end of study period (week 12)
Time Frame
Week 0 and week 12
Secondary Outcome Measure Information:
Title
Change in depression severity
Description
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)
Time Frame
week 0 and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akshya Vasudev, MBBS MD MRCPSych
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Automatic Self Transcending Meditation (ASTM) Versus Heart Rate Variability (HRV) Biofeedback in Patients With Late Life Depression (LLD): a Longitudinal Pilot Feasibility Study

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