N/A
Completed N=95
Automatic Self Transcending Meditation Versus Treatment as Usual
Source: ClinicalTrials.gov NCT02149810 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Change in Heart Rate Variability (SDNN) From Baseline to End of Study — -0.006; -0.116 S.D. of the normalized N-N interval — p=0.28
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Heart Rate Variability (SDNN) From Baseline to End of Study |
-0.006; -0.116 | 0.28 |
| PRIMARY Change in Heart Rate Variability (Low Frequency HRV) From Baseline to End of Study |
0.017; -0.017 | 0.89 |
| SECONDARY Hamilton Rating Scale for Depression 17 Item |
-3.96; -1.30 | 0.030 sig |
| SECONDARY Geriatric Anxiety Inventory |
-3.71; -1.34 | 0.021 sig |
| SECONDARY Physical Activity Scale for the Elderly |
3.32; -7.68 | 0.22 |
| SECONDARY Quality of Life Profile: Seniors Version (Brief) |
10.23; 8.31 | 0.72 |
| SECONDARY Clinical Global Impression - Global Improvement Scale |
2.85; 3.65 | 0.018 sig |
| SECONDARY Toronto Side Effects Scale |
-14.75; -14.62 | 0.99 |
Eligibility 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 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02149810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.