Automatic Self-transcending Meditation (ASTM) Therapy Versus Treatment as Usual (TAU) in Late Life Depression: Implications for Cardiovascular Health and Cross-fertilization Across Different Levels of Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Change in Heart Rate Variability (Low Frequency HRV) From Baseline to End of Study
研究概览
简要总结
Depression is a leading contributor to global burden of disease. Antidepressants do not provide adequate response for many patients. Mind-body therapies are often safe, increasingly embraced by patients, however good quality clinical trial data is limited. The PI has shown that there is autonomic instability in patients with late life depression (LLD). Through his team of across discipline researchers he will investigate benefits of one adjunctive mind-body intervention, automatic self transcending meditation on autonomic instability in LLD and depressive symptoms compared to treatment as usual. If results are positive, such an intervention could be used for management of LLD across all levels of care.
WHAT IS THE INNOVATION AND MAIN QUESTION/HYPOTHESIS UNDERLYING THIS PROPOSAL? The main study objectives are to assess heart rate variability (HRV), other autonomic parameters and depression scores in patients with late life depression undergoing an innovative mind-body therapy 'automatic self-transcending meditation' (ASTM) not previously evaluated in a randomized controlled manner in the treatment of late life depression.
It is expected that adding ASTM to TAU will be better than TAU in improving HRV, depression severity and other autonomic parameters in the treatment of LLD. It is expected that this intervention will produce significant anxiolytic and enhanced quality of life outcomes and will have no major side effects. If the results of this study are positive, it is possible that this intervention could be considered as treatment option for the management of this disabling illness in primary, secondary and tertiary care. Such treatment option would be more cost and staff effective, and self empowering than the current standard of care. It could also provide treatment options for patients who are currently resistant to their antidepressants.
详细描述
Late life depression and cardiovascular autonomic function:
Major depressive disorder in the elderly (in those >60 years of age), also known as late life depression (LLD), is common, disabling and associated with a high mortality rate caused by suicide as well as cardiovascular events compelling appropriate treatment. Research shows that in a naturalistic setting response rate to at least one antidepressant trial of adequate dose and duration alone is around 30-40% thereby necessitating usage of additional interventions. Such therapies include psychological therapies, and, recently, various forms of treatments loosely defined as mind-body therapies such as biofeedback, energy healing, meditation, guided imagery, and yoga. Mind-body therapies are being increasingly embraced by patients as they have negligible side effects, are easy to administer and display beneficial effects on the quality of life as well as comorbid anxiety. There is increasing research on the mechanisms and benefits of such therapies, however, good quality trial data is scant. It is well established that antidepressants work by mostly modifying neurotransmitter levels in the brain. On the other hand, some mind-body therapies target multiple organ systems and hence could offer neurobiological advantages as depression is now recognised as a multi-system disorder. This is particularly relevant to the LLD population where there is increased prevalence of comorbid cardiovascular disorders. Hence, some mind body therapies when offered in combination with antidepressants might have a beneficial effect on both depression and the cardiovascular system.
One of the ways of assessing the cardiovascular system is through measurement of various autonomic parameters i.e. heart rate, blood pressure and heart rate variability. The most commonly reported is heart rate variability (HRV) which is a manifestation of the interplay of the central nervous system and the autonomic nervous system on a beat-by-beat basis. One of the ways of its estimation is by calculating the elapsed time between two consecutive waves, called R waves, on a person's electrocardiogram (ECG). A consistent finding has been that there is reduced HRV in people who have suffered a myocardial infarction (MI), and this phenomena is a predictor of subsequent cardiac arrhythmia and even death. In addition, through previous work the PI has found that in LLD there are significant cardiovascular autonomic disturbances compared to age matched controls after controlling for various risk factors. Other studies conducted in depression across the human life span have found similar results. Hence, if there is a mind-body treatment that specifically targets autonomic dysfunction and has a positive benefit on depressive symptoms, it would be valuable to asses. The investigators would like to investigate such a therapy which has been selected based on previous reports of beneficial effects but has not been evaluated in a randomised controlled trial of LLD patients.
Automatic self-transcending meditation (ASTM):
ASTM is a class of meditation that helps quiet the mind and induces physiological and mental relaxation whilst the eyes are shut. It utilizes a specific sound value (mantra) to draw attention inward and permit the mind to experience a restful but alert state of consciousness. Research suggests that ASTM is easier to learn and to teach in comparison to other meditation techniques including mindfulness. Studies of adult and elderly ASTM practitioners have documented reductions in depressive symptoms, as well as improvements in cardiovascular function among elderly with and without cardiovascular disease. A study of adults with CVD further demonstrated improvements in HRV. Research further suggests ASTM may be particularly well suited to elderly populations. In a randomized controlled trial of elderly retirement home residents which evaluated ASTM with two other meditative techniques and treatment as usual, ASTM produced significantly greater improvements in cognitive function, cardiovascular function and quality of life than all other treatment conditions. A subsequent meta-analysis of all-cause mortality rates among hypertensive elderly who had participated in stress reduction interventions found that ASTM practitioners had a 30% lower cardiovascular mortality rate than four other meditative or relaxation interventions.
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
- 否
入选标准
- •Of either gender, between the age range of 60-85 years.
- •Have an Axis 1 diagnosis of mild to moderate major depressive disorder or bipolar disorder with HAMD-21 score of 8 to
- •Consuming single agent or combination antidepressant therapy at therapeutic doses for a minimum of four weeks.
- •Of good general physical health with no severe cardiovascular disease in the past 12 months, no past history of neurological disease or seizures or history of diabetic neuropathy.
- •Sufficient hearing to be able to follow verbal instructions and able to sit without physical discomfort for 45 minutes.
- •Willing and able to attend 4 initial ASTM training sessions and 75% of weekly follow up sessions.
排除标准
- •Participating in other similar studies.
- •Other significant mental health diagnosis (including Dementia, Substance dependence, Post traumatic stress disorder, panic disorder, Obsessive compulsive disorder, dissociative disorder, neurocognitive disorder and Personality disorder)
- •High risk of suicide as elicited by clinical interview.
- •Psychotic episodes within the past 12 months.
- •Recent (within the past 6 months) head trauma that required emergency care
- •Currently practicing any type of formal meditation, mindfulness or breathing techniques.
- •patients with severe cardiovascular disease in the past 12 months (myocardial infarction, stroke or TIA) as well as history of neurological disease (including Parkinson's Disease) or seizures
结局指标
主要结局
Change in Heart Rate Variability (Low Frequency HRV) From Baseline to End of Study
时间窗: Baseline and week 12
autonomic measure of heart rate variability was assessed at baseline as well as at end of intervention (week 12).
Change in Heart Rate Variability (SDNN) From Baseline to End of Study
时间窗: Baseline and week 12
autonomic measure of heart rate variability was assessed at baseline as well as at end of intervention (week 12).
次要结局
- Hamilton Rating Scale for Depression 17 Item(Baseline and at week 12.)
- Geriatric Anxiety Inventory(Baseline and week 12.)
- Physical Activity Scale for the Elderly(Baseline and week 12)
- Quality of Life Profile: Seniors Version (Brief)(Baseline and week 12.)
- Toronto Side Effects Scale(Week 0 and week 12.)
- Clinical Global Impression - Global Improvement Scale(Week 0 and week 12.)
研究者
Akshya Vasudev
Principal Investigator
Lawson Health Research Institute
