Automatic Self Transcending Meditation Versus Treatment as Usual

NCT02149810 | Completed Results

• 1 other identifier: HSREB
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Major Depressive Disorder

Keywords

MDD

Outcome Measures

Primary Outcomes (2)

• Change in Heart Rate Variability (SDNN) From Baseline to End of Study

  autonomic measure of heart rate variability was assessed at baseline as well as at end of intervention (week 12).

  Baseline and week 12

• Change in Heart Rate Variability (Low Frequency HRV) From Baseline to End of Study

  autonomic measure of heart rate variability was assessed at baseline as well as at end of intervention (week 12).

  Baseline and week 12

Secondary Outcomes (6)

• 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.

• Clinical Global Impression - Global Improvement Scale

  Week 0 and week 12.

Study Arms (2)

Automatic Self Transcending Meditation and Treatment as Usual

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

Participants randomized to control arm (TAU) will continue to receive their treatment as usual including antidepressant medications and/or psychotherapy

Interventions

Automatic Self Transcending Meditation BEHAVIORAL

as above

Also known as: ASTM

Automatic Self Transcending Meditation and Treatment as Usual

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• Willing and able to attend 4 initial ASTM training sessions and 75% of weekly follow up sessions.

You may not qualify if:

• 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. 7. 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• Amtul Z, Arena A, Hirjee H, Khan ZU, Maldeniya PM, Newman RI, Burhan AM, Wetmore S, Vasudev A. A randomized controlled longitudinal naturalistic trial testing the effects of automatic self transcending meditation on heart rate variability in late life depression: study protocol. BMC Complement Altern Med. 2014 Aug 19;14:307. doi: 10.1186/1472-6882-14-307.

  PMID: 25134497 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

This study lacked an active comparator to control for variables such as instructor attention, socializing in a group atmosphere and leaving one's residence for the study intervention. Our study may have been underpowered to assess the HRV changes as well as the potential long-term cardiovascular beneficial effects of this intervention.

Results Point of Contact

• Title: Dr. Akshya Vasudev
• Organization: London Health Sciences Centre

akshya.vasudev@lhsc.on.ca

519-685-8500

Study Officials

• akshya vasudev, MD, MRCPsych

  Western University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 29, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 5, 2021
• Results First Posted: October 5, 2021

Record last verified: 2021-09

Locations

CA (1)