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SSM vs HEP in Late-Life Depression

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ClinicalTrials.gov Identifier: NCT03564041
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
The investigators will conduct a randomized controlled trial (RCT), comparing SSM (n=96) versus HEP (n=96) in 192 LLD participants stratified by site and presence of treatment resistant late life depression (TR-LLD). Participants will be blinded to the treatment hypothesis while investigators, raters and treating clinicians will be additionally blinded to the intervention. Both SSM and HEP will be taught over 4 consecutive days in similar sized groups (4-10 participants) followed by weekly reinforcement sessions for subsequent 11 weeks. Trained raters will collect data on depression symptoms (HAM-D 17 scale) and cognition at baseline, 12-week and 26-week follow-up as the primary and secondary outcome measures respectively.

Condition or disease Intervention/treatment Phase
Late-life Depression Treatment-resistant Depression Behavioral: Sahaj Samadhi Meditation (SSM) Behavioral: Health Enhancement Program (HEP) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be a blinded (rater, investigator, and clinician), 12-week randomized controlled trial (RCT) conducted at Western University, London, ON, Canada, and McGill University, Montreal, QC, Canada.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participant enrolment will be masked from care provider, investigator, and the outcomes assessors through the use of third party randomization. This ensures that only participants, and those necessary in coordinating their participation in the study, are aware of whether or not they are part of the experimental or control group.
Primary Purpose: Treatment
Official Title: Alternative Treatments to Help Late-Life Depression Study Protocol
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sahaj Samadhi Meditation (SSM)
SSM will be taught to participants over 4 consecutive days, for 2 hours each day. Participants will initially learn about the nature of meditation and will be taken through a guided meditation. Afterwards, participants will undergo training which includes understanding the nature of the mind and the thoughts arising from it, guided meditation by the instructor, and a discussion of what is correct and incorrect meditation. Follow-ups will be conducted once every week for the following 11 weeks, each including guided meditation. Participants will be encouraged to practice the meditation at home for 20 minutes per session and will be given weekly practice logs to complete.
Behavioral: Sahaj Samadhi Meditation (SSM)
This is the experimental arm of the study, where participants will be trained in a form of meditation that may improve depressive symptoms.

Health Enhancement Program (HEP)

Arm type: Active control group

HEP controls for several non-specific factors found in a meditation group such as Sahaj Samadhi, including: group support and morale, behavioral activation, reduction of stigma, facilitator attention, treatment duration, and time spent on at-home practice. HEP has been tailored to be structurally equivalent to a SSM intervention, with similar-sized groups, meeting for 4 days for 2 hours, and then a one-hour follow up session weekly for the subsequent 11 weeks, and completing the same amount of home practice (20 minutes twice daily, every day), and will be asked to complete weekly practice logs.

Behavioral: Health Enhancement Program (HEP)
This is the active control group of the study, where participants will be educated on health promotion, healthy diet, music, and exercise, but do not learn breathing techniques, or meditation.




Primary Outcome Measures :
  1. Change in depressive symptoms: Hamilton Depression Scale (HAM-D17) [ Time Frame: Change from week 0 to week 12 and change from week 0 to week 26. ]
    The HAM-D17 is a measure of depressive symptoms. Higher scores on this scale indicate greater depression severity; whereas lower scores indicate minimal/no presence of depression. Change in participant scores on this scale throughout the study will be assessed.


Secondary Outcome Measures :
  1. Delis-Kaplan Executive Function System (D-KEFS): Verbal Fluency Test [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    The Verbal Fluency Test of the D-KEFS asks participants to provide responses according to rules set out by 3 sub-tests (letter fluency, category fluency, and category switching). Correct and incorrect responses are scored. The higher number of correct responses and the lower number of incorrect responses is indicative of stronger verbal fluency. A higher number of incorrect responses and/or lower number of correct responses in one of the sub-tests may indicate neurological dysfunction in a corresponding brain region. No global score is generated.

  2. California Verbal Learning Test-II (CVLT-II), Short Form [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    The CVLT-II is a tool used to assess verbal learning and memory. Scores are determined by recording correct and incorrect responses on each task. Raw scores are used to assess overall performance on the CVLT-II, with higher correct responses and lower incorrect responses indicating good executive functioning.

  3. Rey-Osterrieth Complex Figure-Copy Trial [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    This neuropsychological test asks participants to draw an image they have been shown after no delay (copying it), a short delay, and a longer delay. The accuracy of each drawn image to the original at each time point is indicative of neurological systems' functioning level.


Other Outcome Measures:
  1. Generalized Anxiety Disorder 7-item (GAD-7) scale [ Time Frame: 0 weeks (at screening or at baseline); 12 weeks; and 26 weeks ]
    A measure of anxiety with 7 items scored from 0-3. Higher scores indicate greater depressive symptoms (5-9, mild anxiety; 10-14, moderate anxiety; 15-21 severe anxiety).

  2. Clinical Global Impression (CGI) scale [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    The CGI is a 3-item scale, psychiatric tool meant to provide an overall picture of a participant's illness severity (1-normal to 7-amongst the most severely ill patients), improvement/change (1-very much improved to 7-very much worse), and therapeutic response (0-marked improvement with no side-effects to 4-unchanged or worse and side-effects outweigh the therapeutic effects). No global score is generated.

  3. Athens Insomnia Scale [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    The Athens Insomnia Scale is a measure of sleep difficulties with each item representing a different aspect of sleep (e.g. "Overall Quality of Sleep"). Ratings are from 0 to 4, with 0 being no difficulty with the item and 4 being the most difficulty with the item. Higher overall scores on this scale indicate higher difficulties with sleep.

  4. World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    The WHODAS 2.0 is a 36-item questionnaire assessing a participant's difficulties, due to physical- or mental-health issues, in various activities (e.g. "Self-care") over the past 30 days. Participants provide responses from 1 to 5, with 1 being "None" and 5 being "Extreme or cannot do". Item raw scores, raw domain scores, and domain average scores (out of 5) are generated as well as a "General Disability Score (Total)" and a global average score (out of 5). Higher scores indicate greater difficulty with the item, the domain, overall, or on average.

  5. Euroqol 5 Dimension 5 Level (EQ-5D-5L) [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    The EQ-5D-5L is a 2 page assessment of a participant's self-rated health state on that day. The first page asks participants to indicate how much difficulty they have in a health dimension (e.g. "Mobility") using one of 5 levels: no problems, slight problems, moderate problems, severe problems, or extreme problems. Higher scores indicate greater severity of problems with a health dimension or overall. The second page asks participants to rate their current health state on a scale from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). This section serves as a subjective measure of a participant's own health.

  6. Toronto Side Effects Scale (TSES) [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    This 32-item scale asks about a broad variety of participant reported side effects. The scale assesses the frequency and intensity of side effects on a 5-point Likert scale, with higher scores indicating greater frequency/severity of the side effect.

  7. Montreal Cognitive Assessment (MoCA; London only) [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    The MoCA is a brief 30-item measure of different cognitive abilities (e.g. visuospatial ability, short-term memory). Scores range from 0-30, with scores above 26 indicating normal cognitive functioning.

  8. Wechsler Adult Intelligence Scale (WAIS-IV) -Test of premorbid functioning [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    WAIS-IV-Test of premorbid functioning is a test that assesses cognitive and memory functioning. Performance on this test will be used to estimate a participant's Intelligence Quotient.

  9. Wechsler Adult Intelligence Scale (WAIS-IV)-Digit Span [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    WAIS-IV-Digit Span is an attention span task involving repeating digits in forward order, backward order, as well as sequencing digits in mind.

  10. Delis-Kaplan Executive Function System (D-KEFS) Color Word Test Conditions 1-3 [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    D-KEFS Color Word Test is a test of the ability to rapidly name colour patches, rapidly read colour names, and inhibit a response in favor of another response (inhibition trial).

  11. Phenomenology of Consciousness Inventory (PCI) [ Time Frame: 12 weeks; and 26 weeks ]
    The PCI is a self-report measure containing 53 items about an immediately preceding subjective experience, scored on 7-point scales between opposing statements. The items are organized into 21 scales that include altered states of awareness, self-awareness, altered experiences, volitional control, rationality, internal dialogue, positive affect (which includes joy, love and sexual excitement), negative affect (which includes anger, sadness and fear), imagery, attention, memory and arousal. Scores on the scales will be used to assess the degree to which a person has experienced an altered state of consciousness.

  12. Ryff Scales of Psychological Well-Being (SPWB) [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    SPWB is a self-report measure with 54 short questions that creates scores for six dimensions of psychological well-being: self-acceptance, the establishment of quality ties to others, a sense of autonomy, the pursuit of meaningful goals and a sense of purpose in life, and continued growth and development as a person. This measure is scored on a 6-point scale from "Strongly Disagree" to "Strongly Agree." These scales are regarded as separate dimensions of psychological well-being but can also be aggregated for a global score.

  13. Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    The FFMQ is a 29-item questionnaire that examines five factors of mindfulness including observe, describe, act with awareness, nonjudge and nonreact. Each question is scored from 1 (never of rarely true) to 5 (very often or always true).

  14. Height [ Time Frame: 0 weeks (baseline) ]
    Participants' heights will be recorded in centimeters.

  15. Weight [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    Participants' weights will be recorded in kilograms.

  16. Hip and waist circumference [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    Participants' hip and waist circumferences will be recorded in centimeters.

  17. Medications [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    Physiological measurement. Will record participants' current list of medication, doses, and how long they have been prescribed/taking the medication.

  18. Blood draw [ Time Frame: 0 weeks (baseline) and 12 weeks ]
    Blood will be taken from participants to measure inflammatory markers, that have been linked to depression, in blood serum.

  19. functional Magnetic Resonance Imaging (fMRI)/Magnetic Resonance Imaging (MRI)/ structural Magnetic Resonance Imaging (sMRI) [ Time Frame: 0 weeks (baseline) and 12 weeks ]
    Physiological measurement. Brain scans will measure neural connectivity and cortical thickness.

  20. Gait (London only) [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    Outcomes include mean stride length and mean gait velocity. Both stride length and gait speed will be measured using a GAITRite® portable walkway with embedded pressure sensors.

  21. Fall Efficacy Scale - International (FES-I) [ Time Frame: 0 weeks (baseline); 12 weeks; and 26 weeks ]
    The FES-I is a 16-item scale used to assess fear of falling. Scores range from 16-64, with higher scores indicating greater fear of falling.

  22. Mini-Cog [ Time Frame: 0 weeks (screening) ]
    The Mini-Cog is a tool designed for older adults that screens for cognitive impairments. It has two components: 3-item recall and clock drawing. Points are given for correctly recalling items and correctly drawing a clock (e.g. numbers 1-12 present and in clockwise order). Scores range from 0-5, with higher scores indicating normal cognitive functioning, and scores below 3 indicating increased likelihood of dementia.

  23. Patient Health Questionnaire (PHQ-9) [ Time Frame: 0 weeks (screening), week 12, and week 26. ]
    A measure of depression. Scores of: 0-4, no depression; 5-9, mild depression; 10-14, moderate depression; 15-19, moderately severe depression; 20-27, severe depression.

  24. Antidepressant Treatment History Form (ATHF) [ Time Frame: 0 weeks (screening) ]
    The ATHF is a clinical tool used to record and assess the effectiveness of a participant's past treatment(s) for depression (e.g. drug, dose, duration, etc.). In this study, 2 or more rounds of failed or ineffective treatments qualifies the patient as treatment-resistant.

  25. Mini International Neuropsychiatric [ Time Frame: 0 weeks (screening) ]
    A short diagnostic inventory designed to test for assess the presence of 17 common mental health disorders (e.g. Major Depressive Disorder, Manic Episode, or Alcohol Use Disorder).

  26. Cumulative Illness Rating Scale - Geriatrics (CIRS-G) [ Time Frame: 0 weeks (baseline) ]
    An assessment for 14 body systems. Each are rated on a scale of 0-4; with 0 representing no issue to 4 representing sever problems with that system. A higher score, overall, indicates greater problems or greater severity of problems with the various health systems.

  27. Time Trade Off (TTO) [ Time Frame: Weeks 0, week 12, week 24. ]
    An assessor of the quality of the participants health rated from 0 to 10. Lower numbers indicate a poorer state of health while higher numbers indicate a better state of health.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Patients will be 60-85 years of age presenting with major depressive disorder, single or recurrent, as diagnosed by a Mini Neuropsychiatric Interview (MINI) [41].
  2. A 17-item Hamilton Depression Rating Scale score of 10-22[42].
  3. Participants will be willing and able to attend all 4 training sessions of SSM/HEP, as well as 75% of follow-up sessions.
  4. Have sufficient hearing to follow verbal instructions;
  5. Have adequate understanding of English in London and English and/or French in Montreal.
  6. Able to sit for 45 minutes without discomfort.
  7. Willing to remain on the same antidepressants including dosage for the first 12 weeks of the study.
  8. On the same medications for a minimum of 12 weeks.

Exclusion criteria

  1. Inability to independently provide informed consent.
  2. Clinical evidence of dementia as defined by Mini-Cog < 3.a lifetime diagnosis of other mental disorders, including bipolar I or II disorder, primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).
  3. Substance abuse or dependence within the past 3 months; high risk of suicide (e.g., active suicidal ideation and/or current/recent intent or plan) as assessed by the MINI.
  4. Severe personality disorder, that will interfere with their ability to function in a group setting.
  5. Active substance use; non-correctable as assessed by the MINI.
  6. Clinically significant sensory impairment.
  7. IQ estimated to be below 70 on the Test of Premorbid Functioning
  8. Acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months; having a terminal medical diagnosis with prognosis of less than 12 months.
  9. Currently practicing any form of body-mind intervention on a regular

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564041


Contacts
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Contact: Akshya Vasudev, MBBS, MD 519-667-6693 Akshya.Vasudev@lhsc.on.ca
Contact: Emily Ionson, HrBSc 519-685-8500 ext 74912 Emily.Ionson@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Akshya Vasudev, MD    519-685-8500 ext 76693    akshya.vasudev@lhsc.on.ca   
Principal Investigator: Akshya Vasudev, MBBS, MD         
Sponsors and Collaborators
Lawson Health Research Institute

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03564041     History of Changes
Other Study ID Numbers: 4961
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data with researchers who are not currently involved with the project. The Co-PIs, Co-Is, and research staff at Western and McGill sites will have access to all participant data through the secure online system, REDCap.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lawson Health Research Institute:
depression
late-life
executive functioning
sahaj samadhi
meditation
treatment-resistant

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders