Alternative Treatments to Help Late-Life Depression Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Change in depressive symptoms: Hamilton Depression Scale (HAM-D17)
研究概览
简要总结
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.
详细描述
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 2022. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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].
- •A 17-item Hamilton Depression Rating Scale score of 10-22[42].
- •Participants will be willing and able to attend all 4 training sessions of SSM/HEP, as well as 75% of follow-up sessions.
- •Have sufficient hearing to follow verbal instructions;
- •Have adequate understanding of English in London and English and/or French in Montreal.
- •Able to sit for 45 minutes without discomfort.
- •Willing to remain on the same antidepressants including dosage for the first 12 weeks of the study.
排除标准
- •Inability to independently provide informed consent.
- •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).
- •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.
- •Severe personality disorder, that will interfere with their ability to function in a group setting.
- •Substance use disorder as assessed by the MINI.
- •Clinically significant sensory impairment.
- •IQ estimated to be below 70 on the Test of Premorbid Functioning
- •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.
- •Currently practicing any form of body-mind intervention on a regular basis.
结局指标
主要结局
Change in depressive symptoms: Hamilton Depression Scale (HAM-D17)
时间窗: 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.
次要结局
- Delis-Kaplan Executive Function System (D-KEFS): Verbal Fluency Test(0 weeks (baseline); 12 weeks; and 26 weeks)
- California Verbal Learning Test-II (CVLT-II), Short Form(0 weeks (baseline); 12 weeks; and 26 weeks)
- Rey-Osterrieth Complex Figure-Copy Trial(0 weeks (baseline); 12 weeks; and 26 weeks)