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

Stephen Benjamin Peckham, Emily Ionson, Marouane Nassim, Kevin Ojha, Lena Palaniyappan, Joe Gati, Jean Thebérge, Andrea Lazosky, Mark Speechley, Imants Barušs, Soham Rej, Akshya Vasudev, Stephen Benjamin Peckham, Emily Ionson, Marouane Nassim, Kevin Ojha, Lena Palaniyappan, Joe Gati, Jean Thebérge, Andrea Lazosky, Mark Speechley, Imants Barušs, Soham Rej, Akshya Vasudev

Abstract

Background: Recent 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/design: One 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.

Discussion: This 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 registration: ClinicalTrials.gov, ID: NCT03564041 . Registered on 20 June 2018.

Keywords: Executive functioning; Health Enhancement Program; Late-life depression; Randomized controlled trial; Sahaj Samadhi meditation; Treatment-resistant late-life depression.

Conflict of interest statement

LP receives book royalties from Oxford University Press and income from the SPMM MRCPsych course. He has received investigator-initiated educational grants from Otsuka Canada and Janssen Canada in the last 2 years as well as speaker fees from the Canadian Psychiatric Association in 2018 and Otsuka Canada in 2017.

The other authors have no competing interests to report.

Figures

Fig. 1
Fig. 1
Participant flow chart

References

    1. World Health Organization . Ageing and Health. 2018.
    1. National Center for Health Statistics.Health, United States, 2015: With Special Feature on Racial and Ethnic Health Disparities. Hyattsville, MD. 2016.
    1. Ortman, Jennifer M., Victoria A. Velkoff, and Howard Hogan. An Aging Nation: The Older Population in the United States, Current Population Reports,P25-1140. U.S. Census Bureau, Washington, DC. 2014.
    1. Statistics Canada . Table 052–0005: projected population, by projection scenario, age and sex, as of July 1, Canada, provinces and territories. 2014.
    1. World Health Organization . Mental health of older adults. 2017.
    1. Steffens DC, Fisher GG, Langa KM, Potter GG, Plassman BL. Prevalence of depression among older Americans: the Aging, Demographics and Memory Study. Int Psychogeriatr. 2009;21(5):879–888. doi: 10.1017/S1041610209990044.
    1. Knöchel C, Alves G, Friedrichs B, Schneider B, Schmidt-Rechau A, Wenzler S, et al. Treatment-resistant late-life depression: challenges and perspectives. Curr Neuropharmacol. 2015;13(5):577–591. doi: 10.2174/1570159X1305151013200032.
    1. Smit F, Ederveen A, Cuijpers P, Deeg D, Beekman A. Opportunities for cost-effective prevention of late-life depression: an epidemiological approach. Arch Gen Psychiatry. 2006;63(3):290–296. doi: 10.1001/archpsyc.63.3.290.
    1. Luppa M, König HH, Heider D, Leicht H, Motzek T, Schomerus G, et al. Direct costs associated with depressive symptoms in late life: a 4.5-year prospective study. Int Psychogeriatr. 2013;25(2):292–302. doi: 10.1017/S1041610212001688.
    1. Vasiliadis HM, Dionne PA, Préville M, Gentil L, Berbiche D, Latimer E. The excess healthcare costs associated with depression and anxiety in elderly living in the community. Am J Geriatr Psychiatry. 2013;21(6):536–548. doi: 10.1016/j.jagp.2012.12.016.
    1. Snow CE, Abrams RC. The indirect costs of late-life depression in the United States: a literature review and perspective. Geriatrics. 2016;1(4):30. doi: 10.3390/geriatrics1040030.
    1. Nelson JC, Delucchi K, Schneider LS. Efficacy of second generation antidepressants in late-life depression: a meta-analysis of the evidence. Am J Geriatr Psychiatry. 2008;16(7):558–567. doi: 10.1097/01.JGP.0000308883.64832.ed.
    1. Krishna M, Jauhari A, Lepping P, Turner J, Crossley D, Krishnamoorthy A. Is group psychotherapy effective in older adults with depression? A systematic review. Int J Geriatr Psychiatry. 2011;26(4):331–340. doi: 10.1002/gps.2546.
    1. Myhr G, Payne K. Cost-effectiveness of cognitive-behavioural therapy for mental disorders: implications for public health care funding policy in Canada. Can J Psychiatr. 2006;51(10):662–670. doi: 10.1177/070674370605101006.
    1. Ownby RL, Crocco E, Acevedo A, John V, Loewenstein D. Depression and risk for Alzheimer disease: systematic review, meta-analysis, and metaregression analysis. Arch Gen Psychiatry. 2006;63(5):530–538. doi: 10.1001/archpsyc.63.5.530.
    1. Diniz BS, Butters MA, Albert SM, Dew MA, Reynolds CF. Late-life depression and risk of vascular dementia and Alzheimer’s disease: systematic review and meta-analysis of community-based cohort studies. Br J Psychiatry. 2013;202(5):329–335. doi: 10.1192/bjp.bp.112.118307.
    1. Butters MA, Whyte EM, Nebes RD, Begley AE, Dew MA, Mulsant BH, et al. The nature and determinants of neuropsychological functioning in late-life depression. Arch Gen Psychiatry. 2004;61(6):587–595. doi: 10.1001/archpsyc.61.6.587.
    1. Bhalla RK, Butters MA. Cognitive functioning in late life depression. BCMJ. 2011;53(7):4.
    1. Koenig AM, Bhalla RK, Butters MA. Cognitive functioning and late-life depression. J Int Neuropsychol Soc. 2014;20(5):461–467. doi: 10.1017/S1355617714000198.
    1. Disabato BM, Sheline YI. Biological basis of late life depression. Curr Psychiatry Rep. 2012;14(4):273–279. doi: 10.1007/s11920-012-0279-6.
    1. Hurd MD, Martorell P, Delavande A, Mullen KJ, Langa KM. Monetary costs of dementia in the United States. N Engl J Med. 2013;368(14):1326–1334. doi: 10.1056/NEJMsa1204629.
    1. Toane EB. The Transcendental Meditation program. Can Med Assoc J. 1976;114(12):1095–1096.
    1. Byers AL, Yaffe K, Covinsky KE, Friedman MB, Bruce ML. High occurrence of mood and anxiety disorders among older adults: The National Comorbidity Survey Replication. Arch Gen Psychiatry. 2010;67(5):489–496. doi: 10.1001/archgenpsychiatry.2010.35.
    1. Jevning R, Wilson AF, Davidson JM. Adrenocortical activity during meditation. Horm Behav. 1978;10(1):54–60. doi: 10.1016/0018-506X(78)90024-7.
    1. Schneider RH, Alexander CN, Staggers F, Orme-Johnson DW, Rainforth M, Salerno JW, et al. A randomized controlled trial of stress reduction in African Americans treated for hypertension for over one year. Am J Hypertens. 2005;18(1):88–98. doi: 10.1016/j.amjhyper.2004.08.027.
    1. Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006;35(Suppl 2):ii37–ii41. doi: 10.1093/ageing/afl084.
    1. Kerse N, Flicker L, Pfaff JJ, Draper B, Lautenschlager NT, Sim M, et al. Falls, depression and antidepressants in later life: a large primary care appraisal. PLoS One. 2008;3(6):e2423. doi: 10.1371/journal.pone.0002423.
    1. Anstey KJ, Burns R, von Sanden C, Luszcz MA. Psychological well-being is an independent predictor of falling in an 8-year follow-up of older adults. J Gerontol B Psychol Sci Soc Sci. 2008;63(4):P249–PP57. doi: 10.1093/geronb/63.4.P249.
    1. Miller AH, Maletic V, Raison CL. Inflammation and its discontents: the role of cytokines in the pathophysiology of major depression. Biol Psychiatry. 2009;65(9):732–741. doi: 10.1016/j.biopsych.2008.11.029.
    1. Black DS, Cole SW, Irwin MR, Breen E, St Cyr NM, Nazarian N, et al. Yogic meditation reverses NF-κB and IRF-related transcriptome dynamics in leukocytes of family dementia caregivers in a randomized controlled trial. Psychoneuroendocrinology. 2013;38(3):348–355. doi: 10.1016/j.psyneuen.2012.06.011.
    1. Kim SM, Park JM, Seo HJ. Effects of mindfulness-based stress reduction for adults with sleep disturbance: a protocol for an update of a systematic review and meta-analysis. Syst Rev. 2016;5:51. doi: 10.1186/s13643-016-0228-2.
    1. Park JM, Choi IR. The effect of K-MBSR program on stress, stress coping style, depression, anger and sleep of middle aged women. J Korean Acad Nurs. 2016;46(2):194–206. doi: 10.4040/jkan.2016.46.2.194.
    1. Bremner JD, Narayan M, Anderson ER, Staib LH, Miller HL, Charney DS. Hippocampal volume reduction in major depression. Am J Psychiatry. 2000;157(1):115–118. doi: 10.1176/ajp.157.1.115.
    1. Treadway MT, Waskom ML, Dillon DG, Holmes AJ, Park MTM, Chakravarty MM, et al. Illness progression, recent stress, and morphometry of hippocampal subfields and medial prefrontal cortex in major depression. Biol Psychiatry. 2015;77(3):285–294. doi: 10.1016/j.biopsych.2014.06.018.
    1. Kurth F, Cherbuin N, Luders E. Reduced age-related degeneration of the hippocampal subiculum in long-term meditators. Psychiatry Res. 2015;232(3):214–218. doi: 10.1016/j.pscychresns.2015.03.008.
    1. Irwin MR, Olmstead R, Carrillo C, Sadeghi N, Breen EC, Witarama T, et al. Cognitive behavioral therapy vs. Tai Chi for late life insomnia and inflammatory risk: a randomized controlled comparative efficacy trial. Sleep. 2014;37(9):1543–1552. doi: 10.5665/sleep.4008.
    1. Ionson E, Limbachia J, Rej S, Puka K, Newman RI, Wetmore S, et al. Effects of Sahaj Samadhi Meditation on heart rate variability and depressive symptoms in patients with late-life depression: a randomized controlled trial. BJPsych. Accepted, in press.
    1. Prathikanti S, Rivera R, Cochran A, Tungol JG, Fayazmanesh N, Weinmann E. Treating major depression with yoga: a prospective, randomized, controlled pilot trial. PLoS One. 2017;12(3):e0173869. doi: 10.1371/journal.pone.0173869.
    1. Vasudev A, Arena A, Burhan AM, Ionson E, Hirjee H, Maldeniya P, et al. A training programme involving automatic self-transcending meditation in late-life depression: preliminary analysis of an ongoing randomised controlled trial. BJPsych Open. 2016;2(2):195–198. doi: 10.1192/bjpo.bp.115.002394.
    1. Vasudev A, Torres-Platas G, Kerfoot K, Ref S. A systematic review of meditative practices in late life mood and cognitive problems. Am J Geriatric Psychiatry. In press.
    1. Marciniak R, Sheardova K, Cermáková P, Hudeček D, Sumec R, Hort J. Effect of meditation on cognitive functions in context of aging and neurodegenerative diseases. Front Behav Neurosci. 2014;8:17. doi: 10.3389/fnbeh.2014.00017.
    1. Infante JR, Peran F, Rayo JI, Serrano J, Domínguez ML, Garcia L, et al. Levels of immune cells in transcendental meditation practitioners. Int J Yoga. 2014;7(2):147–151. doi: 10.4103/0973-6131.133899.
    1. Lecrubier Y, Sheehan DV, Weiller E, Amorim P, Bonora I, Harnett-Sheehan K, et al. The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: reliability and validity according to the CIDI. Eur Psychiatry. 1997;12(5):224–231. doi: 10.1016/S0924-9338(97)83296-8.
    1. Zimmerman M, Martinez JH, Young D, Chelminski I, Dalrymple K. Severity classification on the Hamilton Depression Rating Scale. J Affect Disord. 2013;150(2):384–388. doi: 10.1016/j.jad.2013.04.028.
    1. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56–62. doi: 10.1136/jnnp.23.1.56.
    1. Kocsis JH, Gelenberg AJ, Rothbaum B, Klein DN, Trivedi MH, Manber R, et al. Chronic forms of major depression are still undertreated in the 21st century: systematic assessment of 801 patients presenting for treatment. J Affect Disord. 2008;110(1–2):55–61. doi: 10.1016/j.jad.2008.01.002.
    1. Rogal SS, Dew MA, Fontes P, DiMartini AF. Early treatment of depressive symptoms and long-term survival after liver transplantation. Am J Transplant. 2013;13(4):928–935. doi: 10.1111/ajt.12164.
    1. Treviño LA, Ruble MW, Treviño K, Weinstein LM, Gresky DP. Antidepressant medication prescribing practices for treatment of major depressive disorder. Psychiatr Serv. 2017;68(2):199–202. doi: 10.1176/appi.ps.201600087.
    1. Rey A. L’examen psychologique dans les cas d’encéphalopathie traumatique. (Les problems.) [The psychological examination in cases of traumatic encepholopathy. Problems] Arch Psychologie. 1941;28:215–285.
    1. Osterrieth PA. Filetest de copie d’une figure complex: contribution a l’etude de la perception et de la memoire [The test of copying a complex figure: a contribution to the study of perception and memory] Arch Psychol. 1944;30:286–356.
    1. Stern RA, Singer EA, Duke LM, Singer NG, Morey CE, Daughtrey EW, et al. The Boston qualitative scoring system for the Rey-Osterrieth complex figure: description and interrater reliability. Clin Issues. 1994;8(3):309–322.
    1. Elderkin-Thompson V, Boone KB, Kumar A, Mintz J. Validity of the Boston qualitative scoring system for the Rey-Osterrieth complex figure among depressed elderly patients. J Clin Exp Neuropsychol. 2004;26(5):598–607.
    1. Delis DC, Kramer JH, Kaplan E, Ober BA. California Verbal Learning Test—Second Edition. San Antonio: Psychological Corporation; 2000.
    1. Wechsler D. Wechsler Adult Intelligence Scale (4th edition) San Antonio: Psychological Corporation; 2008.
    1. Webber TA, Soble JR. Utility of various WAIS-IV Digit Span indices for identifying noncredible performance validity among cognitively impaired and unimpaired examinees. Clin Neuropsychol. 2018;32(4):657–670. doi: 10.1080/13854046.2017.1415374.
    1. Delis DC, Kaplan E, Kramer JH. Delis-Kaplan Executive Function System:Technical Manual. San Antonio: Harcourt Assessment Company; 2001.
    1. Linn BS, Linn MW, Gurel L. Cumulative Illness Rating Scale. J Am Geriatr Soc. 1968;16(5):622–626. doi: 10.1111/j.1532-5415.1968.tb02103.x.
    1. Miller MD, Towers A. A Manual of Guidelines for Scoring the Cumulative Illness Rating Scale for Geriatrics (CIRS-G). Pittsburgh; 1991. p. 31.
    1. Kroenke K, Spitzer RL, Williams JB, Löwe B. The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review. Gen Hosp Psychiatry. 2010;32(4):345–359. doi: 10.1016/j.genhosppsych.2010.03.006.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–613. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–1097. doi: 10.1001/archinte.166.10.1092.
    1. Busner J, Targum SD. The Clinical Global Impressions Scale: applying a research tool in clinical practice. Psychiatry (Edgmont) 2007;4(7):28–37.
    1. Soldatos CR, Dikeos DG, Paparrigopoulos TJ. Athens Insomnia Scale: validation of an instrument based on ICD-10 criteria. J Psychosom Res. 2000;48(6):555–560. doi: 10.1016/S0022-3999(00)00095-7.
    1. Üstün TB, Kostanjsek N, Chatterji S, Rehm J. Measuring health and disability: manual for WHO Disability Assessment Schedule (WHODAS 2.0) Geneva: World Health Organization; 2010.
    1. van Reenen M, Janssen B. EQ-5D-5L user guide: basic information on how to use the EQ-5D-5L instrument: The EuroQol Group; 2015.
    1. Dolan P, Gudex C, Kind P, Williams A. The time trade-off method: results from a general population study. Health Econ. 1996;5(2):141–154. doi: 10.1002/(SICI)1099-1050(199603)5:2<141::AID-HEC189>;2-N.
    1. Vanderkooy JD, Kennedy SH, Bagby RM. Antidepressant side effects in depression patients treated in a naturalistic setting: a study of bupropion, moclobemide, paroxetine, sertraline, and venlafaxine. Can J Psychiatr. 2002;47(2):174–180. doi: 10.1177/070674370204700208.
    1. Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695–699. doi: 10.1111/j.1532-5415.2005.53221.x.
    1. Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995;69(4):719–727. doi: 10.1037/0022-3514.69.4.719.
    1. Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006;13(1):27–45. doi: 10.1177/1073191105283504.
    1. Pekala RJ. Quantifying consciousness: an empirical approach. New York: Plenum Press; 1991.
    1. Wong D, Schranz AL, Bartha R. Optimized in vivo brain glutamate measurement using long-echo-time semi-LASER at 7 T. NMR Biomed. 2018;31(11):e4002. doi: 10.1002/nbm.4002.
    1. Dewan N, MacDermid JC. Fall Efficacy Scale-International (FES-I) J Physiother. 2014;60(1):60. doi: 10.1016/j.jphys.2013.12.014.
    1. Keefe RS, Kraemer HC, Epstein RS, Frank E, Haynes G, Laughren TP, et al. Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials. Innov Clin Neurosci. 2013;10(5–6 Suppl A):4S–19S.

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