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

Z. Amtul, Amanda Arena, H. Hirjee, Z. U. Khan, P. Maldeniya, Ronnie I. Newman, A. Burhan, Stephen Wetmore, Akshya Vasudev

BMC Complementary and Alternative Medicine August 19, 2014 DOI: 10.1186/1472-6882-14-307 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial protocol Longitudinal Pilot study Peer reviewed
Population Adults aged 60 to 85 with late life depression
Intervention treatment as usual
Dose twice daily for twenty minutes each time
Duration 4 consecutive days of training, weekly follow-up sessions for 11 weeks, assessments at baseline and 4, 8, 12, and 24 weeks post intervention
Topics Depression Meditation
Registration NCT02149810
Key findings The authors propose a randomized, controlled, longitudinal trial to test whether Sahaj Samadhi Meditation, a form of automatic self-transcending meditation, improves cardiovascular autonomic parameters and neuropsychological symptoms of depression and anxiety in late life depression. They report that their earlier pilot study suggested this technique may have promise for cardiovascular autonomic disturbances and for depression and anxiety symptoms, while noting that response rates to antidepressant trials remain poor.

Abstract

BackgroundThe 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/DesignPatients 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.DiscussionThis 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 registrationClinicaltrials.gov NCT02149810, date registered: 05/28/2014.

Comparable studies

Other randomized controlled trials on depression, most cited first.

Study Year Design Participants
A Randomized Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Major Depression Subjects with DSM-IV major depression (treatment resistant) 2006 Randomized, placebo-controlled, double-blind crossover study n = 18
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety 2016 Randomized controlled trial n = 51
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

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