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Automatic Self Transcending Meditation Versus Treatment as Usual

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ClinicalTrials.gov Identifier: NCT02149810
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Akshya Vasudev, Lawson Health Research Institute

Brief Summary:

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 albeit the limited good quality clinical trial data. 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:The investigators hypothesise that in patients with LLD treatment as usual(TAU) +ASTM will lead to a significant increase in HRV from baseline to end of study period as compared to treatment as usual TAU. The investigators also hypothesise that ASTM+TAU will cause a significant difference in other autonomic parameters including heart rate and blood pressure changes in presence of a physiological stress test (hand grip), depression and depression related pathologies such as anxiety and improve quality of life compared to TAU.

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Automatic Self Transcending Meditation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Automatic Self Transcending Meditation and Treatment as Usual
Participants in the ASTM group will undergo ASTM training in groups of four .This involves participating in four, 90-120 minutes sessions each of four consecutive days. This will be followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants will be asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants will be asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
Behavioral: Automatic Self Transcending Meditation
as above
Other Name: ASTM

No Intervention: Treatment as Usual
Participants randomized to control arm (TAU) will continue to receive their treatment as usual including antidepressant medications and/or psychotherapy



Primary Outcome Measures :
  1. change in heart rate variability from baseline to end of study [ Time Frame: Baseline and week 12 ]
    autonomic measure of heart rate variability will be assessed at baseline as well as at end of intervention (week 12).


Secondary Outcome Measures :
  1. change in depression severity [ Time Frame: Baseline and at weeks 0,4, 8, 12 and 24 ]
    Change in Hamilton 17 item depression rating scale and the geriatric depression scale (GDS).

  2. change in comorbid anxiety [ Time Frame: baseline and at week 4, 8, 12 and 24 ]
    Change in geriatric anxiety inventory (GAI).

  3. physical activity [ Time Frame: baseline and at weeks 4, 8, 12 and 24 ]
    Change in physical activity scale of the elderly (PASE).

  4. quality of life [ Time Frame: Baseline and at weeks 4, 8, 12 and 24 ]
    Change in quality of life profile seniors version (QOLPS) scale



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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:

  • Of either gender, between the age range of 60-85 years.
  • Have an Axis 1 diagnosis of mild to moderate major depressive disorder with -HAMD-21 score of 8 to 22.
  • 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

Exclusion Criteria:

  • Participating in other similar studies
  • Other significant mental health diagnosis
  • Having a diagnosis of dementia (MMSE<24)
  • High risk of suicide as elicited by clinical interview
  • Psychotic episode within the past 12 months
  • Recent head trauma
  • Currently on tricyclic antidepressants, monoamine oxidase inhibitors, serotonin noradrenaline reuptake inhibitors or on any antipsychotic agent

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): NCT02149810


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
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Principal Investigator: akshya vasudev, MD, MRCPsych Western University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Akshya Vasudev, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02149810    
Other Study ID Numbers: HSREB
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Keywords provided by Akshya Vasudev, Lawson Health Research Institute:
MDD
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders