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Automatic Self Transcending Meditation Versus Treatment as Usual

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02149810
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : October 5, 2021
Last Update Posted : October 5, 2021
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Akshya Vasudev, Lawson Health Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Behavioral: Automatic Self Transcending Meditation
Enrollment 95
Recruitment Details The recruitment strategy consisted of advertisements placed in community centers and libraries in London (Ontario, Canada)and surrounding areas, with the headline 'A Meditation Study for Seniors looking for Relief from Feeling Low and Depressed'. We screened 270 potential participants from June 2014 to August 2016, through physician referrals and recruitment posters. Of these, 95 met the study criteria and were enrolled and randomized.
Pre-assignment Details  
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Hide Arm/Group Description Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them. Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Period Title: Overall Study
Started 48 47
Baseline 47 44
Week 4 43 42
Week 8 40 43
Week 12 40 43
Week 24 31 0 [1]
Completed 40 43
Not Completed 8 4
Reason Not Completed
Physician Decision             1             2
Lost to Follow-up             2             1
Withdrawal by Subject             5             1
[1]
Not applicable study was amended such that week 24 data was not collected for TAU participants.
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual Total
Hide Arm/Group Description Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minutes sessions each of four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them. Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy Total of all reporting groups
Overall Number of Baseline Participants 40 43 83
Hide Baseline Analysis Population Description
Analysis was completed only for those participants who completed a week 12 (primary end point) assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 43 participants 83 participants
69.45  (5.80) 68.30  (6.50) 68.88  (6.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 83 participants
Female
24
  60.0%
33
  76.7%
57
  68.7%
Male
16
  40.0%
10
  23.3%
26
  31.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Caucasian Number Analyzed 40 participants 43 participants 83 participants
27
  67.5%
34
  79.1%
61
  73.5%
Non-caucasian Number Analyzed 40 participants 43 participants 83 participants
13
  32.5%
9
  20.9%
22
  26.5%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 40 participants 43 participants 83 participants
28.97  (5.00) 30.81  (7.00) 29.89  (6.00)
Mini Mental State Exam (MMSE)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 40 participants 43 participants 83 participants
28.55  (1.70) 29.00  (1.40) 28.78  (1.55)
[1]
Measure Description: The Mini Mental State Exam (MMSE) is a cognitive function test for use in elderly patients. This exam includes tests of orientation, attention, memory, language and visual-spatial skills. Scores range from 0 to 30 with higher scores indicating better cognitive functioning.
Cumulative Illness Rating Scale for Geriatrics (CIRS-G)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 40 participants 43 participants 83 participants
9.46  (3.80) 8.53  (3.70) 9.00  (3.75)
[1]
Measure Description: The Cumulative Illness Rating Scale for Geriatrics (CIRS-G) compiles and quantifies medical problems in elderly patients. The CIRS-G rates different body systems from 0 to 4 with 0 indicating no problem, 1 current mild or past significant problem, 3 severe/constant significant disability/"uncontrollable" chronic problems, 4 extremely severe/immediate treatment required/end organ failure/severe impairment in function. A total is calculated for all body systems with scores ranging from 0 to 56, with lower scores indicating better health.
Late onset of Major Depressive Episode   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 39 participants 76 participants
23.00
25
  64.1%
48
  63.2%
[1]
Measure Description: Late onset of a major depressive episode was defined as the first depressive episode occurring at the age of 50 or older. A count of the number of participants who self-reported their first depressive episode as occurring at age 50 or older is reported.
[2]
Measure Analysis Population Description: There were 7 cases of missing data for onset of major depressive episode.
Two or More Major Depressive Episodes   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 39 participants 75 participants
25
  69.4%
26
  66.7%
51
  68.0%
[1]
Measure Analysis Population Description: There were 8 cases of missing data for frequency of major depressive episodes.
Smoker   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 38 participants 71 participants
4
  12.1%
6
  15.8%
10
  14.1%
[1]
Measure Analysis Population Description: There were 12 case of missing data for smoking status.
Taking antidepressant medications  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 83 participants
30
  75.0%
26
  60.5%
56
  67.5%
Greater than 1 alcohol drink per week   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 38 participants 72 participants
12
  35.3%
14
  36.8%
26
  36.1%
[1]
Measure Analysis Population Description: There were 11 cases of missing data for drinking status.
Greater than 1 alcohol drink per week   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 38 participants 72 participants
12
  35.3%
14
  36.8%
26
  36.1%
[1]
Measure Analysis Population Description: There were 11 cases of missing data for drinking status.
Taking two or more antidepressant medications  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 83 participants
15
  37.5%
15
  34.9%
30
  36.1%
1.Primary Outcome
Title Change in Heart Rate Variability (SDNN) From Baseline to End of Study
Hide Description autonomic measure of heart rate variability was assessed at baseline as well as at end of intervention (week 12).
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants were missing data for autonomic measures.
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Hide Arm/Group Description:
Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Overall Number of Participants Analyzed 37 42
Mean (95% Confidence Interval)
Unit of Measure: S.D. of the normalized N-N interval
-0.006
(-0.15 to 0.14)
-0.116
(-0.26 to 0.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Automatic Self Transcending Meditation and Treatment as Usual
Comments The primary focus of this study was the interaction effect of treatment on heart rate variability at Weeks 0 and 12. On the assumption that this effect size is medium (Cohen's f = .25), calculations (using G*Power) 23 indicate that a sample size of 80 yield power estimates of .99 for both the interaction and the main effect of time. The study enrolled 95 participants to account for participant attrition.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments The a priori threshold for statistical significance was p = 0.05.
Method Mixed Models Analysis
Comments Linear mixed models, controlling for baseline score, were used to compare the SSM and TAU groups' change score from baseline to 12-week on SDNN.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.109
Confidence Interval (2-Sided) 95%
-0.09 to 0.31
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in Heart Rate Variability (Low Frequency HRV) From Baseline to End of Study
Hide Description autonomic measure of heart rate variability was assessed at baseline as well as at end of intervention (week 12).
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants were missing data for autonomic measures.
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Hide Arm/Group Description:
Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Overall Number of Participants Analyzed 37 42
Mean (95% Confidence Interval)
Unit of Measure: msec^2
0.017
(-0.32 to 0.35)
-0.017
(-0.36 to 0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Automatic Self Transcending Meditation and Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments The a priori threshold for statistical significance was set at p = 0.05.
Method Mixed Models Analysis
Comments Linear mixed models, controlling for baseline score, were used to compare the SSM and TAU groups' change score from baseline to 12-week on LF HRV.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.034
Confidence Interval (2-Sided) 95%
-0.44 to 0.51
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Hamilton Rating Scale for Depression 17 Item
Hide Description Change in Hamilton 17 (HDSR-17) item depression rating scale from baseline to week 12. Minimum value is 0, maximum value is 52; lower values indicate better outcomes.
Time Frame Baseline and at week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Hide Arm/Group Description:
Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Overall Number of Participants Analyzed 40 43
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-3.96
(-6.00 to -1.91)
-1.30
(-2.65 to 0.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Automatic Self Transcending Meditation and Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments The a priori threshold for statistical significance was set at p = 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.66
Confidence Interval (2-Sided) 95%
-5.05 to -0.26
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Geriatric Anxiety Inventory
Hide Description Change in geriatric anxiety inventory (GAI). Scores range from 0 to 20 with lower scores indicating a better outcome.
Time Frame Baseline and week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Hide Arm/Group Description:
Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Overall Number of Participants Analyzed 40 43
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-3.71
(-5.15 to -2.26)
-1.34
(-2.77 to 0.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Automatic Self Transcending Meditation and Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments The a priori threshold for statistical significance was set at p = 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.37
Confidence Interval (2-Sided) 95%
-4.37 to -0.36
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Physical Activity Scale for the Elderly
Hide Description Change in physical activity scale for the elderly (PASE). Scores range from 0 to 400 or more, with higher scores indicating a better outcome.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Hide Arm/Group Description:
Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Overall Number of Participants Analyzed 40 43
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.32
(-12.02 to 18.67)
-7.68
(-18.09 to 2.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Automatic Self Transcending Meditation and Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments The a priori threshold for statistical significance was set at p = 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 11.00
Confidence Interval (2-Sided) 95%
-7.01 to 29.01
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Quality of Life Profile: Seniors Version (Brief)
Hide Description Change in quality of life profile seniors version (QOLPS) scale. Scores range from 0 to 90 with higher scored indicating a better outcome.
Time Frame Baseline and week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Hide Arm/Group Description:
Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Overall Number of Participants Analyzed 40 43
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
10.23
(2.95 to 17.50)
8.31
(0.63 to 16.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Automatic Self Transcending Meditation and Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments The a priori threshold for statistical significance was set at p = 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.91
Confidence Interval (2-Sided) 95%
-8.54 to 12.37
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Clinical Global Impression - Global Improvement Scale
Hide Description Change in Clinical Global Impression - Global Improvement Scale (CGI-I). Scores range from 0 to 7 with lower values indicating a better outcome.
Time Frame Week 0 and week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Hide Arm/Group Description:
Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Overall Number of Participants Analyzed 40 43
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.85
(2.30 to 3.40)
3.65
(3.26 to 4.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Automatic Self Transcending Meditation and Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments The a priori threshold for statistical significance was set at p = 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-1.46 to -0.15
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Toronto Side Effects Scale
Hide Description Change in the Toronto Side Effects Scale (TSES). Scores Range from 31 to 775 or higher with lower scored indicating a better outcome.
Time Frame Week 0 and week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Hide Arm/Group Description:
Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Overall Number of Participants Analyzed 40 43
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-14.75
(-30.46 to 0.96)
-14.62
(-30.25 to 1.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Automatic Self Transcending Meditation and Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments The a priori threshold for statistical significance was set at p = 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-21.94 to 21.66
Estimation Comments [Not Specified]
9.Post-Hoc Outcome
Title Percentage of Participants Achieving a Response Criterion Set at ≥50% Decrease From Baseline, on the Hamilton Rating Scale for Depression 17 Item (HDRS 17)
Hide Description The percentage of participants achieving a significant response to the study intervention. Response was defined as a decrease in score of 50% or more on the Hamilton Rating Scale for Depression 17 item (HDRS 17) from week 0 to week 12.
Time Frame Week 0 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Hide Arm/Group Description:
Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Overall Number of Participants Analyzed 40 43
Measure Type: Number
Unit of Measure: % of participants achieving response
30.0 11.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Automatic Self Transcending Meditation and Treatment as Usual
Comments Generalised linear models were used to compare the proportion of participants who responded to the intervention (≥50% decrease from baseline on the HRSD, defined a priori) at the end of intervention (week 12).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments The a priori threshold for statistical significance was set at p = 0.05.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.26
Confidence Interval (2-Sided) 95%
1.01 to 10.53
Estimation Comments [Not Specified]
10.Post-Hoc Outcome
Title Percentage of Participants Achieving Remission on the Hamilton Rating Scale for Depression 17 Item (HDRS-17)
Hide Description The percentage of participants achieving remission, defined as a participant achieving a HDRS-17 score less than or equal to 7 at week 12 follow up.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Hide Arm/Group Description:
Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them.
Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Overall Number of Participants Analyzed 40 43
Measure Type: Number
Unit of Measure: % of participants achieving remission
40.0 16.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Automatic Self Transcending Meditation and Treatment as Usual
Comments Generalised linear models were used to compare the proportion of the proportion of participants who achieved remission (scores ≤7 on the HRSD, defined a priori) at the end of intervention (week 12).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments The a priori threshold for statistical significance was set at p = 0.05.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.36
Confidence Interval (2-Sided) 95%
1.06 to 10.64
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Hide Arm/Group Description Participants in the ASTM group underwent ASTM training in groups of four or more. This involved participating in four, 90-120 minute sessions each on four consecutive days. This was followed by once weekly 45-60 minute follow up sessions for 12 weeks. In addition participants were asked to practice ASTM at home for 20 minutes twice daily over the study period (24 weeks). Participants were asked to log practice frequency and any other noteworthy observations in the log sheet provided to them. Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
All-Cause Mortality
Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/43 (0.00%) 
Hide Serious Adverse Events
Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/43 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Automatic Self Transcending Meditation and Treatment as Usual Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/43 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Akshya Vasudev
Organization: London Health Sciences Centre
Phone: 519-685-8500 ext 75504
EMail: akshya.vasudev@lhsc.on.ca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Akshya Vasudev, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02149810    
Other Study ID Numbers: HSREB
First Submitted: May 19, 2014
First Posted: May 29, 2014
Results First Submitted: June 2, 2021
Results First Posted: October 5, 2021
Last Update Posted: October 5, 2021