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Completed

NCT Number: NCT01908673

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

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.

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Key information

Conditions

Late Life Depression

Age range

66 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRV Biofeedback

Behavioral

ASTM

Behavioral

Other names: Automatic Self Transcedental Meditation

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 26, 2013
Registry last updated
Feb 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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