Late Life Depression Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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