Trial Outcomes & Findings for Automatic Self Transcending Meditation Versus Treatment as Usual (NCT NCT02149810)

NCT ID: NCT02149810

Last Updated: 2021-10-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 95 participants
• Primary outcome timeframe: Baseline and week 12
• Results posted on: 2021-10-05

Participant Flow

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.

Participant milestones

Measure	Automatic Self Transcending Meditation and Treatment as Usual 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.	Treatment as Usual Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Overall Study STARTED	48	47
Overall Study Baseline	47	44
Overall Study Week 4	43	42
Overall Study Week 8	40	43
Overall Study Week 12	40	43
Overall Study Week 24	31	0
Overall Study COMPLETED	40	43
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Measure	Automatic Self Transcending Meditation and Treatment as Usual 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.	Treatment as Usual Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Overall Study Physician Decision	1	2
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	5	1

Baseline Characteristics

There were 7 cases of missing data for onset of major depressive episode.

Baseline characteristics by cohort

Measure	Automatic Self Transcending Meditation and Treatment as Usual n=40 Participants 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.	Treatment as Usual n=43 Participants Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy	Total n=83 Participants Total of all reporting groups
Age, Continuous	69.45 years STANDARD_DEVIATION 5.80 • n=40 Participants	68.30 years STANDARD_DEVIATION 6.50 • n=43 Participants	68.88 years STANDARD_DEVIATION 6.15 • n=83 Participants
Sex: Female, Male Female	24 Participants n=40 Participants	33 Participants n=43 Participants	57 Participants n=83 Participants
Sex: Female, Male Male	16 Participants n=40 Participants	10 Participants n=43 Participants	26 Participants n=83 Participants
Race/Ethnicity, Customized Caucasian	27 Participants n=40 Participants	34 Participants n=43 Participants	61 Participants n=83 Participants
Race/Ethnicity, Customized Non-caucasian	13 Participants n=40 Participants	9 Participants n=43 Participants	22 Participants n=83 Participants
BMI	28.97 kg/m^2 STANDARD_DEVIATION 5.00 • n=40 Participants	30.81 kg/m^2 STANDARD_DEVIATION 7.00 • n=43 Participants	29.89 kg/m^2 STANDARD_DEVIATION 6.00 • n=83 Participants
Mini Mental State Exam (MMSE)	28.55 units on a scale STANDARD_DEVIATION 1.70 • n=40 Participants	29.00 units on a scale STANDARD_DEVIATION 1.40 • n=43 Participants	28.78 units on a scale STANDARD_DEVIATION 1.55 • n=83 Participants
Cumulative Illness Rating Scale for Geriatrics (CIRS-G)	9.46 units on a scale STANDARD_DEVIATION 3.80 • n=40 Participants	8.53 units on a scale STANDARD_DEVIATION 3.70 • n=43 Participants	9.00 units on a scale STANDARD_DEVIATION 3.75 • n=83 Participants
Late onset of Major Depressive Episode	23.00 Participants n=37 Participants • There were 7 cases of missing data for onset of major depressive episode.	25 Participants n=39 Participants • There were 7 cases of missing data for onset of major depressive episode.	48 Participants n=76 Participants • There were 7 cases of missing data for onset of major depressive episode.
Two or More Major Depressive Episodes	25 Participants n=36 Participants • There were 8 cases of missing data for frequency of major depressive episodes.	26 Participants n=39 Participants • There were 8 cases of missing data for frequency of major depressive episodes.	51 Participants n=75 Participants • There were 8 cases of missing data for frequency of major depressive episodes.
Smoker	4 Participants n=33 Participants • There were 12 case of missing data for smoking status.	6 Participants n=38 Participants • There were 12 case of missing data for smoking status.	10 Participants n=71 Participants • There were 12 case of missing data for smoking status.
Taking antidepressant medications	30 Participants n=40 Participants	26 Participants n=43 Participants	56 Participants n=83 Participants
Greater than 1 alcohol drink per week	12 Participants n=34 Participants • There were 11 cases of missing data for drinking status.	14 Participants n=38 Participants • There were 11 cases of missing data for drinking status.	26 Participants n=72 Participants • There were 11 cases of missing data for drinking status.
Taking two or more antidepressant medications	15 Participants n=40 Participants	15 Participants n=43 Participants	30 Participants n=83 Participants

PRIMARY outcome

Timeframe: Baseline and week 12

Population: Four participants were missing data for autonomic measures.

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

Outcome measures

Measure	Automatic Self Transcending Meditation and Treatment as Usual n=37 Participants 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.	Treatment as Usual n=42 Participants Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Change in Heart Rate Variability (SDNN) From Baseline to End of Study	-0.006 S.D. of the normalized N-N interval Interval -0.15 to 0.14	-0.116 S.D. of the normalized N-N interval Interval -0.26 to 0.03

PRIMARY outcome

Timeframe: Baseline and week 12

Population: Four participants were missing data for autonomic measures.

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

Outcome measures

Measure	Automatic Self Transcending Meditation and Treatment as Usual n=37 Participants 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.	Treatment as Usual n=42 Participants Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Change in Heart Rate Variability (Low Frequency HRV) From Baseline to End of Study	0.017 msec^2 Interval -0.32 to 0.35	-0.017 msec^2 Interval -0.36 to 0.33

SECONDARY outcome

Timeframe: Baseline and at week 12.

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.

Outcome measures

Measure	Automatic Self Transcending Meditation and Treatment as Usual n=40 Participants 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.	Treatment as Usual n=43 Participants Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Hamilton Rating Scale for Depression 17 Item	-3.96 units on a scale Interval -6.0 to -1.91	-1.30 units on a scale Interval -2.65 to 0.05

SECONDARY outcome

Timeframe: Baseline and week 12.

Change in geriatric anxiety inventory (GAI). Scores range from 0 to 20 with lower scores indicating a better outcome.

Outcome measures

Measure	Automatic Self Transcending Meditation and Treatment as Usual n=40 Participants 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.	Treatment as Usual n=43 Participants Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Geriatric Anxiety Inventory	-3.71 units on a scale Interval -5.15 to -2.26	-1.34 units on a scale Interval -2.77 to 0.1

SECONDARY outcome

Timeframe: Baseline and week 12

Change in physical activity scale for the elderly (PASE). Scores range from 0 to 400 or more, with higher scores indicating a better outcome.

Outcome measures

Measure	Automatic Self Transcending Meditation and Treatment as Usual n=40 Participants 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.	Treatment as Usual n=43 Participants Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Physical Activity Scale for the Elderly	3.32 units on a scale Interval -12.02 to 18.67	-7.68 units on a scale Interval -18.09 to 2.73

SECONDARY outcome

Timeframe: Baseline and week 12.

Change in quality of life profile seniors version (QOLPS) scale. Scores range from 0 to 90 with higher scored indicating a better outcome.

Outcome measures

Measure	Automatic Self Transcending Meditation and Treatment as Usual n=40 Participants 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.	Treatment as Usual n=43 Participants Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Quality of Life Profile: Seniors Version (Brief)	10.23 units on a scale Interval 2.95 to 17.5	8.31 units on a scale Interval 0.63 to 16.0

SECONDARY outcome

Timeframe: Week 0 and week 12.

Change in Clinical Global Impression - Global Improvement Scale (CGI-I). Scores range from 0 to 7 with lower values indicating a better outcome.

Outcome measures

Measure	Automatic Self Transcending Meditation and Treatment as Usual n=40 Participants 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.	Treatment as Usual n=43 Participants Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Clinical Global Impression - Global Improvement Scale	2.85 units on a scale Interval 2.3 to 3.4	3.65 units on a scale Interval 3.26 to 4.04

SECONDARY outcome

Timeframe: Week 0 and week 12.

Change in the Toronto Side Effects Scale (TSES). Scores Range from 31 to 775 or higher with lower scored indicating a better outcome.

Outcome measures

Measure	Automatic Self Transcending Meditation and Treatment as Usual n=40 Participants 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.	Treatment as Usual n=43 Participants Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Toronto Side Effects Scale	-14.75 units on a scale Interval -30.46 to 0.96	-14.62 units on a scale Interval -30.25 to 1.02

POST_HOC outcome

Timeframe: Week 0 and week 12

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.

Outcome measures

Measure	Automatic Self Transcending Meditation and Treatment as Usual n=40 Participants 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.	Treatment as Usual n=43 Participants Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Percentage of Participants Achieving a Response Criterion Set at ≥50% Decrease From Baseline, on the Hamilton Rating Scale for Depression 17 Item (HDRS 17)	30.0 % of participants achieving response	11.6 % of participants achieving response

POST_HOC outcome

Timeframe: Week 12

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.

Outcome measures

Measure	Automatic Self Transcending Meditation and Treatment as Usual n=40 Participants 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.	Treatment as Usual n=43 Participants Participants randomized to the control arm (TAU) continued to receive their treatment as usual including antidepressant medications and/or psychotherapy
Percentage of Participants Achieving Remission on the Hamilton Rating Scale for Depression 17 Item (HDRS-17)	40.0 % of participants achieving remission	16.3 % of participants achieving remission

Adverse Events

Automatic Self Transcending Meditation and Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Akshya Vasudev

London Health Sciences Centre

Phone: 519-685-8500

Email: akshya.vasudev@lhsc.on.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place