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临床试验/NCT03607708
NCT03607708暂停不适用

Alternative Treatments To Prevent Cognitive Decline in Older Adults With Depression and Anxiety

Lady Davis Institute4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
30
试验地点
4
主要终点
Changes in Glutathione measured by magnetic resonance spectroscopy(MRS) from baseline to 8- week follow -up

研究概览

简要总结

Major depression and anxiety disorders are leading causes of disability worldwide. These mental disorders deeply impact social functioning and physical health in more than 300,000-600,000 Canadians over the age of 60. Depressed and anxious older adults have a 2-3 times increased risk of developing dementia and cognitive decline.

Mindfulness-based cognitive therapy (MBCT) is a group meditation intervention that has been beneficial in treating depression and anxiety in younger adults. Our research group has experience conducting clinical trials of MBCT in older adults with depression and anxiety. Meditation therapies may prevent cognitive decline, but no previous study has examined this with MBCT.

In this 8-week clinical trial, Investigators are examining whether MBCT can strengthen the structural and functional integrity of brain networks and improve cognitive resilience in vulnerable depressed and anxious older adults. Investigators will also examine whether MBCT can improve depression, anxiety symptoms, disability, and quality of life in patients.

Investigators will conduct a pilot randomized controlled trial (RCT), comparing Mindfulness-Based Cognitive Therapy (MBCT; n=15) versus a Health Enhancement Program (HEP; n=15) active control in 30 older patients (>60) with depression or anxiety. Participants will be blinded to the treatment hypothesis while investigators and raters will be additionally blinded to group assignment. Both MBCT and HEP will be taught in weekly sessions over 8 weeks in similar sized groups (4-10 participants).

Investigators will measure the effect of these interventions on brain network function and structure using magnetic resonance imaging at baseline and 8-week timepoints. Investigators will also assess cognitive functioning and a range of clinical symptoms/quality of life measures at baseline, 8-week and 6-month follow-up.

Investigators anticipate that this project will improve quality of life in depressed and anxious older adults by enhancing brain resilience, cognitive function, and general mental health. This project will provides essential pilot data for a longer-term definitive neuroimaging trial of MBCT to assess the potential of this intervention to prevent cognitive decline and dementia in older adults.

详细描述

Context - Review of Literature

Depression and anxiety are common in older adults affecting 300,000-600,000 Canadian seniors annually1. About 30% of patients aged ≥60 suffering from these conditions have cognitive dysfunction across several domains 2,3, and an episode of depression or anxiety in this population increases the odds of developing dementia by two-fold4-6. Cognitive impairment and dementia are major causes of disability and dependency among older people worldwide. These conditions confer poor quality of life and place people in an extremely vulnerable condition7.

Adequate treatment of a depressive/anxiety episode can improve short- and longer-term cognition in executive, language, memory, and processing speed domains8. Because depression and anxiety in late-life are reversible to a certain extent and they are important risk factors for subsequent cognitive decline; improving these conditions can ultimately improve quality of life, lengthen the independent living of vulnerable people, reduces stress and caregiver burden. Unfortunately, existing pharmacotherapy treatments for late-life depression and anxiety have limited effectiveness (50-60% of patients are treatment-resistant), are poorly tolerated, and access is difficult due to the absence of trained personnel. Additionally, there are long waiting lists (up to 12 months) in most Canadian provinces and interventions are administered one-on-one, which is costly for the health system9. Thus, there is an urgent need for novel treatments for late-life depression and anxiety that can also improve cognition and even potentially prevent dementia in the longer-term.

Mindfulness-based cognitive therapy (MBCT) is a group intervention that teaches mindfulness meditation (non-judgemental awareness of the present moment)10. MBCT is scalable, accessible, cost efficient, and has been shown to decrease symptoms of depression, anxiety and other psychiatric disorders11. Additionally, MBCT is associated with improved quality of life 12, disability, caregiver burden and stress13. Studies conducted by our own group have found that mindfulness meditation is feasible and well-tolerated in older patients suffering from depression and anxiety14. While the neural mechanisms of MBCT are not fully understood, previous work in younger adults has shown that this intervention increases grey matter density in the brain's hippocampus, known to be involved in learning, memory and stress15. Moreover, long-term meditation practitioners displayed decreased age-related degeneration of the hippocampus16 These findings are relevant because decreased hippocampal volume17,18 and brain functional connectivity (default mode network)19 are commonly found in depressed patients. Additionally, these findings are also observed early in Alzheimer's disease and are associated with cognitive decline20.

Study Purpose and Rationale

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
Single (Outcomes Assessor)

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

入选标准

  • Patients will be >60 years of age presenting with clinically meaningful symptoms of depression or anxiety (PHQ-9 or GAD-7 scores ≥10).
  • Participants will be willing and able to attend at least 75% of weekly HEP or MBCT sessions.
  • Have sufficient hearing to follow verbal instructions;
  • Have adequate understanding of English and/or French.
  • Able to sit for 20-25 minutes without discomfort.

排除标准

  • Inability to provide informed consent.
  • Clinical evidence of dementia as defined by the Mini-Cog; a lifetime diagnosis of bipolar I or II disorder or primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).
  • High acute risk of suicide (e.g., active suicidal ideation and/or current/recent intent or plan).
  • Severe personality disorder, that will interfere with their ability to function in a group setting.
  • Active substance use; non-correctable.
  • Clinically significant sensory impairment.
  • Diagnosed Intellectual Deficiency (e.g. Childhood Mental Retardation, Autism)
  • 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 meditation on a regular basis.
  • Unwilling to remain on the same psychotropic medications including dosage for the first 8 weeks of the study

结局指标

主要结局

Changes in Glutathione measured by magnetic resonance spectroscopy(MRS) from baseline to 8- week follow -up

时间窗: Baseline and 8 weeks

Increase in levels of Glutathione from baseline to 8- week follow -up in key mood regulating brain areas of the DMN (ventro-medial prefrontal cortex).

Changes in functional connectivity (rs-fMRI) from baseline to 8- week follow -up

时间窗: Baseline and 8 weeks

Using an 8- week RCT, assess the effects of MBCT (compared to an active control condition) on functional integrity of key default- mode network (DMN) nodes using functional connectivity measured by resting-state fMRI, Hypothesis . Compared to HEP controls, MBCT- treated patients will show larger increases from baseline to 8- week follow -up in 1) functional connectivity between regions implicated in the DMN

Structural Volume Change using structural sMRI from baseline to 8- week follow -up

时间窗: Baseline and 8 weeks

Using an 8- week RCT, assess the effects of MBCT (compared to an active control condition) on changes in changes Structural Volume Investigators hypothesis : Compared to HEP controls, MBCT- treated patients will show volume increase from baseline to 8- week follow -up in the bilateral hippocampal and posterior cingulate cortex nodes of the DMN,

次要结局

  • Improvements in cognitive functio(Baseline and 8 weeks)

研究者

发起方
Lady Davis Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Soham Rej MD, MSc

MD, MSc

Lady Davis Institute

研究点 (4)

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