Trial Outcomes & Findings for Breathing Meditation Intervention for Post Traumatic Stress Disorder (NCT NCT02366403)
NCT ID: NCT02366403
Last Updated: 2022-07-12
Results Overview
Posttraumatic Stress Disorder Checklist-Civilian Version (PCL-C) (Blanchard et al., 1996) is a 17-item self- report scale that assesses PTSD symptom severity in the past month corresponding to DSM-IV criteria for PTSD. Scores range from 17-85 with higher scores reflecting greater severity. We used the civilian version to assess symptoms from both military and non-military trauma.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
baseline, after treatment (six weeks), one month after treatment, and one year after treatment
Results posted on
2022-07-12
Participant Flow
Participant milestones
| Measure |
Sudarshan Kriya Yoga
a standardized meditation program
SKY meditation: SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment.
|
CPT-C
CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
CPT-C: CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
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|---|---|---|
|
Overall Study
STARTED
|
41
|
44
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
11
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Breathing Meditation Intervention for Post Traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Sudarshan Kriya Yoga
n=41 Participants
a standardized meditation program
SKY meditation: SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment.
|
CPT-C
n=44 Participants
CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
CPT-C: CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
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Total
n=85 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
56.9 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
44 participants
n=7 Participants
|
85 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, after treatment (six weeks), one month after treatment, and one year after treatmentPosttraumatic Stress Disorder Checklist-Civilian Version (PCL-C) (Blanchard et al., 1996) is a 17-item self- report scale that assesses PTSD symptom severity in the past month corresponding to DSM-IV criteria for PTSD. Scores range from 17-85 with higher scores reflecting greater severity. We used the civilian version to assess symptoms from both military and non-military trauma.
Outcome measures
| Measure |
Sudarshan Kriya Yoga
n=41 Participants
a standardized meditation program
SKY meditation: SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment.
|
CPT-C
n=44 Participants
CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
CPT-C: CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
|
|---|---|---|
|
Change in PTSD Checklist (PCL)
change from baseline to end of treatment
|
-5.6 score on a scale
Standard Deviation 9.5
|
-6.8 score on a scale
Standard Deviation 11.4
|
|
Change in PTSD Checklist (PCL)
change from baseline to one month after treatment
|
-4.8 score on a scale
Standard Deviation 10.5
|
-6.8 score on a scale
Standard Deviation 11.9
|
|
Change in PTSD Checklist (PCL)
change from baseline to one year after treatment
|
-4.4 score on a scale
Standard Deviation 11.4
|
-6.2 score on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: baseline, after treatment (six weeks), one month after treatment, and one year after treatmentThe BDI-II scale is a 21-item self-report measure that assesses depression symptom severity. Items are rated on a 4-point scale according to how much the symptom bothered the respondent over the prior two weeks. Scores range from 0-63 with higher scores reflecting greater severity.
Outcome measures
| Measure |
Sudarshan Kriya Yoga
n=41 Participants
a standardized meditation program
SKY meditation: SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment.
|
CPT-C
n=44 Participants
CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
CPT-C: CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
|
|---|---|---|
|
Change in Beck Depression Inventory II (BDI-II)
Change from baseline to end of treatment
|
-6.1 score on a scale
Standard Deviation 6.8
|
-3.6 score on a scale
Standard Deviation 10.9
|
|
Change in Beck Depression Inventory II (BDI-II)
Change from baseline to one month after treatment
|
-4.7 score on a scale
Standard Deviation 8.7
|
-2.8 score on a scale
Standard Deviation 11.7
|
|
Change in Beck Depression Inventory II (BDI-II)
Change from baseline to one year after treatment
|
-5.6 score on a scale
Standard Deviation 9.6
|
-4.5 score on a scale
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: baseline, after treatment (six weeks), one month after treatment, and one year after treatmentA 20-item self-report measure assessing positive and negative mood states over "the past few weeks" on a 5-point scale. Scores for positive and negative affect range from 10-50 with higher scores reflecting stronger affect.
Outcome measures
| Measure |
Sudarshan Kriya Yoga
n=41 Participants
a standardized meditation program
SKY meditation: SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment.
|
CPT-C
n=44 Participants
CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
CPT-C: CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
|
|---|---|---|
|
Change in Positive and Negative Affect Schedule (PANAS)
PANAS positive: change from baseline to end of treatment
|
2.5 score on a scale
Standard Deviation 5.8
|
0.3 score on a scale
Standard Deviation 5.9
|
|
Change in Positive and Negative Affect Schedule (PANAS)
PANAS positive: change from baseline to one month after treatment
|
1.3 score on a scale
Standard Deviation 8.6
|
-1.3 score on a scale
Standard Deviation 7.1
|
|
Change in Positive and Negative Affect Schedule (PANAS)
PANAS positive: change from baseline to one year after treatment
|
-0.1 score on a scale
Standard Deviation 10.5
|
0.4 score on a scale
Standard Deviation 7.0
|
|
Change in Positive and Negative Affect Schedule (PANAS)
PANAS negative: change from baseline to end of treatment
|
-3.2 score on a scale
Standard Deviation 4.6
|
-0.9 score on a scale
Standard Deviation 8.8
|
|
Change in Positive and Negative Affect Schedule (PANAS)
PANAS negative: change from baseline to one month after treatment
|
-2.9 score on a scale
Standard Deviation 6.7
|
-1.2 score on a scale
Standard Deviation 8.4
|
|
Change in Positive and Negative Affect Schedule (PANAS)
PANAS negative: change from baseline to one year after treatment
|
-1.8 score on a scale
Standard Deviation 8.2
|
-1.7 score on a scale
Standard Deviation 8.0
|
Adverse Events
Sudarshan Kriya Yoga
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CPT-C
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sudarshan Kriya Yoga
n=41 participants at risk
a standardized meditation program
SKY meditation: SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment.
|
CPT-C
n=44 participants at risk
CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
CPT-C: CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
|
|---|---|---|
|
Psychiatric disorders
Admission to inpatient psychiatry
|
0.00%
0/41 • baseline to one year posttreatment (i.e. 58 weeks)
Study staff conducted safety evaluations and followed safety protocols whenever a participant endorsed any suicidal or homicidal ideation, including via self report measures.
|
2.3%
1/44 • Number of events 1 • baseline to one year posttreatment (i.e. 58 weeks)
Study staff conducted safety evaluations and followed safety protocols whenever a participant endorsed any suicidal or homicidal ideation, including via self report measures.
|
Other adverse events
| Measure |
Sudarshan Kriya Yoga
n=41 participants at risk
a standardized meditation program
SKY meditation: SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment.
|
CPT-C
n=44 participants at risk
CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
CPT-C: CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
|
|---|---|---|
|
Psychiatric disorders
Distressed and lost to follow up
|
0.00%
0/41 • baseline to one year posttreatment (i.e. 58 weeks)
Study staff conducted safety evaluations and followed safety protocols whenever a participant endorsed any suicidal or homicidal ideation, including via self report measures.
|
2.3%
1/44 • Number of events 1 • baseline to one year posttreatment (i.e. 58 weeks)
Study staff conducted safety evaluations and followed safety protocols whenever a participant endorsed any suicidal or homicidal ideation, including via self report measures.
|
Additional Information
Peter Bayley, PhD
War Related Illness and Injury Study Center, VA Palo Alto Healthcare System
Phone: 650 493-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place