SSM vs HEP in Late-Life Depression
关键词
抽象
描述
RECRUITMENT AND CONSENT:
Participants will either be recruited from primary-, secondary-, and tertiary-care centres or from self-referral (general public). Montreal patients will be recruited from the Douglas Institute and associated Integrated University Health and Social Services Centres (CIUSSS)-Ouest de l'ile Local Community Services Centres (CLSCs) (CLSC Verdun and CLSC Lasalle), Jewish General Hospital (JGH) Psychiatry clinics (Institute for Community and Family Psychiatry) and associated CIUSSS-Centre-Ouest family medicine clinics/CLSCs: CLSC Benny Farm, CLSC Rene Cassin, CLSC Côte Des Neiges, CLSC Metro, CLSC Parc Extension, Herzl Family Medicine JGH, St-Mary's Dept. of Psychiatry, and McGill University Health Centre (MUHC) Dept. of Psychiatry. London participants will be recruited from London Health Science Centre (LHSC) sites (Victoria Hospital and University Hospital) and Parkwood Institute - Mental Health Care Building. Participants will be screened for eligibility and given a letter of information (LOI) for their review. After 24 hours, a research assistant will contact the participant and, if they are interested in participating and eligible to participate in the research study, they will be recruited into the study after valid consent is received.
STUDY INTERVENTION:
This study is a 12-week, randomized controlled trial seeking to recruit 192 participants with late-life depression total across two sites - (1) McGill University, Montreal, Quebec (QC), and (2) University of Western Ontario in London, Ontario (ON). Participants will be randomly assigned to one of two conditions: Sahaj Samadhi Meditation (SSM) or the Health Enhancement Program (HEP). The SSM intervention will be offered by trained and certified teachers from the Art of Living Foundation at Montreal and London between August 2018 and August 2021. The HEP intervention will be offered by a trained Nurse Practitioner, Social Worker, Psychologist, Occupational Therapist or other qualified professional at Montreal and London between August 2018 and August 2021. Raters, clinicians, and care providers will be blind to participant study condition.
SSM (the experimental group) and HEP (the active control group) require participants to attend training for 4 days, attend weekly follow-up sessions, and to practice the trained techniques at home for 20-minutes per day (details of each intervention can be found below). Participants will additionally be asked to fill out "homework logs" to record days they practiced the trained technique. A total of 3 assessment sessions are planned for participants to attend: to occur at baseline (0-week) as well as at 12-week and 26-week follow-ups.
MENTAL HEALTH ASSESSMENTS:
Participants will be screened using the Screening for Cognitive Impairment in Older Adults (Mini-Cog), Patient Health Questionnaire (PHQ-9), the Magnetic Resonance Imaging (MRI) pre-screening questionnaire, the Mini International Neuropsychiatric Interview, and the Antidepressant Treatment History Form (ATHF). Participants will be tested for the primary outcome, depression, using the Hamilton Depression Rating Scale (HAM-D17). The secondary outcome, executive functioning, will be measured by the Delis-Kaplan Executive Function System (D-KEFS), Rey-Osterrieth Complex Figure-Copy Trial, and the California Verbal Learning Test-II-Short Form. Measures of primary and secondary outcomes will be administered at all 3 assessment sessions. All measures are described below.
BLOOD DRAW:
Blood draws will be performed at baseline (0-weeks) and 12-week follow-up by a qualified nurse at the CLSC in Montreal and Parkwood Mental Health in London. The blood collected will be stored at the Douglas Mental Health University Institute in Montreal, QC, and at Robart's Research Institute in London, ON.
GAIT:
Gait data will be collected in London, Ontario, only. The data to be collected is weight, height, waist circumference, and hip circumference. Gait data will be measured alongside the Falls Efficacy Scale (FES-I) (described below).
MRI:
The investigators aim to recruit a total of 50 participants (25 from each group) from the SSM/HEP study into a magnetic resonance imaging (MRI) study that will involve MRI scans at baseline and at the 12-week follow-up. Participants eligible for this sub-study will have had to complete the MRI pre-screening questionnaire. Those who are part of this sub-study will be invited to attend two MRI scanning sessions, which are expected to take about 1.5 h, to occur at baseline and the 12-week follow-up. Each MRI appointment will be completed in addition to the tasks described above.
日期
最后验证: | 07/31/2019 |
首次提交: | 05/15/2018 |
提交的预估入学人数: | 06/18/2018 |
首次发布: | 06/19/2018 |
上次提交的更新: | 08/19/2019 |
最近更新发布: | 08/21/2019 |
实际学习开始日期: | 08/19/2018 |
预计主要完成日期: | 08/30/2021 |
预计完成日期: | 08/30/2021 |
状况或疾病
干预/治疗
Behavioral: Sahaj Samadhi Meditation (SSM)
Behavioral: Health Enhancement Program (HEP)
相
手臂组
臂 | 干预/治疗 |
---|---|
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. |
Other: 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. |
资格标准
有资格学习的年龄 | 60 Years 至 60 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | 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 |
结果
主要结果指标
1. Change in depressive symptoms: Hamilton Depression Scale (HAM-D17) [Change from week 0 to week 12 and change from week 0 to week 26.]
次要成果指标
1. Delis-Kaplan Executive Function System (D-KEFS): Verbal Fluency Test [0 weeks (baseline); 12 weeks; and 26 weeks]
2. California Verbal Learning Test-II (CVLT-II), Short Form [0 weeks (baseline); 12 weeks; and 26 weeks]
3. Rey-Osterrieth Complex Figure-Copy Trial [0 weeks (baseline); 12 weeks; and 26 weeks]
其他成果措施
1. Generalized Anxiety Disorder 7-item (GAD-7) scale [0 weeks (at screening or at baseline); 12 weeks; and 26 weeks]
2. Clinical Global Impression (CGI) scale [0 weeks (baseline); 12 weeks; and 26 weeks]
3. Athens Insomnia Scale [0 weeks (baseline); 12 weeks; and 26 weeks]
4. World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [0 weeks (baseline); 12 weeks; and 26 weeks]
5. Euroqol 5 Dimension 5 Level (EQ-5D-5L) [0 weeks (baseline); 12 weeks; and 26 weeks]
6. Toronto Side Effects Scale (TSES) [0 weeks (baseline); 12 weeks; and 26 weeks]
7. Montreal Cognitive Assessment (MoCA; London only) [0 weeks (baseline); 12 weeks; and 26 weeks]
8. Wechsler Adult Intelligence Scale (WAIS-IV) -Test of premorbid functioning [0 weeks (baseline); 12 weeks; and 26 weeks]
9. Wechsler Adult Intelligence Scale (WAIS-IV)-Digit Span [0 weeks (baseline); 12 weeks; and 26 weeks]
10. Delis-Kaplan Executive Function System (D-KEFS) Color Word Test Conditions 1-3 [0 weeks (baseline); 12 weeks; and 26 weeks]
11. Phenomenology of Consciousness Inventory (PCI) [12 weeks; and 26 weeks]
12. Ryff Scales of Psychological Well-Being (SPWB) [0 weeks (baseline); 12 weeks; and 26 weeks]
13. Five Facet Mindfulness Questionnaire (FFMQ) [0 weeks (baseline); 12 weeks; and 26 weeks]
14. Height [0 weeks (baseline)]
15. Weight [0 weeks (baseline); 12 weeks; and 26 weeks]
16. Hip and waist circumference [0 weeks (baseline); 12 weeks; and 26 weeks]
17. Medications [0 weeks (baseline); 12 weeks; and 26 weeks]
18. Blood draw [0 weeks (baseline) and 12 weeks]
19. functional Magnetic Resonance Imaging (fMRI)/Magnetic Resonance Imaging (MRI)/ structural Magnetic Resonance Imaging (sMRI) [0 weeks (baseline) and 12 weeks]
20. Gait (London only) [0 weeks (baseline); 12 weeks; and 26 weeks]
21. Fall Efficacy Scale - International (FES-I) [0 weeks (baseline); 12 weeks; and 26 weeks]
22. Mini-Cog [0 weeks (screening)]
23. Patient Health Questionnaire (PHQ-9) [0 weeks (screening), week 12, and week 26.]
24. Antidepressant Treatment History Form (ATHF) [0 weeks (screening)]
25. Mini International Neuropsychiatric [0 weeks (screening)]
26. Cumulative Illness Rating Scale - Geriatrics (CIRS-G) [0 weeks (baseline)]
27. Time Trade Off (TTO) [Weeks 0, week 12, week 24.]