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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

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ClinicalTrials.gov Identifier: NCT01908673
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
Akshya Vasudev, Lawson Health Research Institute

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.


Condition or disease Intervention/treatment Phase
Late Life Depression Behavioral: HRV biofeedback Behavioral: ASTM Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: HRV biofeedback
heart rate variability biofeedback
Behavioral: HRV biofeedback
Active Comparator: ASTM
Automatic Self Transcedental Meditation
Behavioral: ASTM
Other Name: Automatic Self Transcedental Meditation



Primary Outcome Measures :
  1. Change in Heart Rate Variability (HRV) [ Time Frame: Week 0 and week 12 ]
    HRV will be assessed at baseline and at end of study period (week 12)


Secondary Outcome Measures :
  1. Change in depression severity [ Time Frame: week 0 and week 12 ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years to 80 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908673


Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Akshya Vasudev, MBBS MD MRCPSych University of Western Ontario, Canada

Responsible Party: Akshya Vasudev, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01908673     History of Changes
Other Study ID Numbers: HSREB 103966
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014

Keywords provided by Akshya Vasudev, Lawson Health Research Institute:
heart rate variability biofeedback
automatic self transcedental meditation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders