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Open Access Study protocol

A randomized controlled longitudinal naturalistic trial testing the effects of automatic self transcending meditation on heart rate variability in late life depression: study protocol

Zareen Amtul1, Amanda Arena1, Hussein Hirjee2, Zaineb U Khan1, Pramudith M Maldeniya1, Ronnie I Newman3, Amer M Burhan1, Stephen Wetmore4 and Akshya Vasudev156*

Author Affiliations

1 Division of Geriatric Psychiatry, Department of Psychiatry, Western University, London N6A 5 W9, ON, Canada

2 Schulich School of Medicine and Dentistry, Western University, London N6A 5C1, ON, Canada

3 Department of Research and Health Promotion, The Art of Living Foundation, San Francisco, CA, USA

4 Department of Family Medicine, Western University, London Health Sciences Centre, London N6A 5C1, ON, Canada

5 Division of Clinical Pharmacology, Department of Medicine, Western University, London N6A 1H4, ON, Canada

6 A2-607, Victoria Hospital, London Health Sciences Centre, 800 Commissioners Road East, London N6A 5 W9, ON, Canada

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BMC Complementary and Alternative Medicine 2014, 14:307  doi:10.1186/1472-6882-14-307

Published: 19 August 2014

Abstract

Background

The prevalence and socioeconomic cost of late life depression (LLD) is on the rise, while the response rate to antidepressant trials remains poor. Various mind-body therapies are being embraced by patients as they are considered safe and potentially effective, yet little is known regarding the effectiveness of such therapies to improve LLD symptoms. Among the mind-body therapies currently in practice, the results of our pilot study have shown that a particular meditation technique called Sahaj Samadhi Meditation, which belongs to the category of meditation termed automatic self-transcending meditation (ASTM) may have some promise in improving cardiovascular autonomic disturbances associated with LLD as well as ameliorating symptoms of depression and anxiety.

Methods/Design

Patients between the ages of 60 and 85 with LLD will be randomized either to ASTM plus treatment as usual (TAU) or TAU alone to assess changes in cardiovascular autonomic parameters, neuropsychological symptoms of depression and anxiety as well as quality of life. The instructional phase of the intervention consists of 4 consecutive days of meditation training, after which participants are encouraged to meditate twice daily for twenty minutes each time at home. The intervention also includes once weekly follow up sessions for the subsequent 11 weeks. The planned study has one and a half year recruitment period. Participants will be assessed at baseline and at 4, 8, 12 and 24 weeks post intervention.

Discussion

This study should provide a unique data source from a randomized, controlled, longitudinal trial to investigate the effects of a form of ASTM on cardiovascular autonomic and neuropsychological health in LLD.

Trial registration

Clinicaltrials.gov NCT02149810, date registered: 05/28/2014.

Keywords:
Cardiovascular autonomic testing; Automatic self transcending meditation; Late life depression; Heart rate variability