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
S. B. Peckham, Emily Ionson, Marouane Nassim, Kevin Ojha, Lena Palaniyappan, J. Gati, Jean Théberge, A. Lazosky, Mark Speechley, Imants Baruss, Soham Rej, Akshya Vasudev
Trials October 24, 2019 DOI: 10.1186/s13063-019-3682-z (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol Peer reviewed |
|---|---|
| Sample size | 192 |
| Population | Adults with late-life depression (LLD), including those with treatment-resistant late-life depression (TR-LLD), recruited at two sites in London, Ontario, and Montreal, Quebec, Canada |
| Interventions | Sahaj Samadhi meditation (SSM) Health Enhancement Program (HEP) |
| Duration | 12-week intervention with assessments at baseline (0 weeks), post intervention (12 weeks), and 26 weeks after baseline |
| Measures | Hamilton Depression Rating Scale (HAM-D), executive functioning, exploratory physiological and mood-based measures |
| Topics | Depression Meditation |
| Registration | NCT03564041 |
| Key findings | The protocol proposes a two-site, blinded randomized controlled trial to test whether Sahaj Samadhi meditation (SSM), compared with an active control (Health Enhancement Program), reduces depressive symptoms and improves executive functioning in late-life depression. The authors state that this trial should more definitively assess whether SSM can be used as an augmentation strategy in routine clinical care for LLD and TR-LLD, and could inform whether SSM can improve or prevent cognitive decline. |
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.
Comparable studies
Other randomized controlled trials on depression, most cited first.
Citations in the library
Cited by 2
- Health effects of Sahaj Samadhi meditation: A scoping review of evidence across cognitive, neurophysiological and clinical domains. Complementary Therapies in Medicine August 4, 2026
- Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation Trials January 8, 2020
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