Sahaj Samadhi meditation vs a Health Enhancement Program in improving late-life depression severity and executive function: study protocol for a two-site, randomized controlled trial

Abstract

BackgroundRecent estimates suggest an 11% prevalence of current late-life depression (LLD) and a lifetime prevalence of 16–20%. LLD leads to cognitive disturbance as well as a nearly two to three times increased risk of dementia. We conducted a recent randomized controlled trial (RCT) which demonstrated that Sahaj Samadhi meditation (SSM), an easy-to-implement, meditation-based augmentation strategy, led to higher rates of symptom remission when compared to treatment as usual (40.0 vs 16.3%; odds ratio, 3.36; 95% CI 1.06–10.64; p = 0.040). Here we present a protocol describing a two-site, blinded, RCT, comparing an SSM arm to an active-control arm – a Health Enhancement Program (HEP) intervention – in their ability to reduce depressive symptoms and improve executive functioning, among several other exploratory outcomes.Methods/designOne hundred and ninety-two (n = 192) participants with LLD will be recruited at two sites (London, ON, Canada, and Montreal, QC, Canada). Participants will undergo stratified randomization with regards to site and the presence of treatment-resistant-LLD (TR-LLD) or not, to either SSM or HEP. We will assess change in (1) depression severity using the Hamilton Depression Rating Scale (HAM-D), (2) executive functioning, and (3) other exploratory physiological and mood-based measures, at baseline (0 weeks), post intervention (12 weeks), and 26 weeks after baseline. Raters, clinicians, and care providers will be blinded to group allocation while participants will be blinded to the study hypotheses.DiscussionThis study should more definitively assess whether SSM can be used as an augmentation strategy in routine clinical care for patients suffering from LLD and TR-LLD. If the effects of SSM are significantly better than HEP, it will offer support for the routine use of this intervention to manage LLD/TR-LLD and comorbid declines in executive dysfunction. The results of this study could also inform whether SSM can improve/prevent cognitive decline in LLD.Trial registrationClinicalTrials.gov, ID: NCT03564041. Registered on 20 June 2018.

The relevance of the Five Facet Mindfulness Questionnaire according to the views of experienced meditators in India.

“…Two other participants practiced Sahaj Samadhi meditation, which is a natural and easy meditation technique practiced with or without a personalized mantra. This meditation focuses on cultivating positive attributes and increasing awareness, as outlined by Peckham et al (2019). One participant practiced Samyama meditation, a stage described as Samadhi (the eighth limb) in Ashtanga yoga (eight limbs of yoga), according to Patanjali’s Yoga Sutras as explained by Sadhasivam et al (2021).…”

Connecting During COVID-19: A Protocol of a Volunteer-Based Telehealth Program for Supporting Older Adults' Health

“…Comparable intervention studies for late-life stress, fear, depression, and anxiety have detected statistical significances and clinically meaningful effects ( 20 , 34 ) including one volunteer-based program with a sample size of 150–200, which showed efficacy in preventing episodes of major depression in older persons with subsyndromal symptoms ( 19 ).…”

Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation

“…HEP has been designed and used as a manualized active control in other meditation-based intervention trials [37][38][39]. HEP controls for several nonspecific factors found in a meditation group, including group support and morale, behavioral activation, reduction of stigma, facilitator attention, treatment duration, and time spent on at-home practice (adapted from a published manual [40]).…”