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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01908673
Study type Interventional
Source Lawson Health Research Institute
Contact
Status Completed
Phase N/A
Start date August 2013
Completion date February 2014

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