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Breathing Meditation Intervention for Post Traumatic Stress Disorder

Breathing Meditation Intervention for Post-Traumatic Stress Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02366403
Enrollment
85
Registered
2015-02-19
Start date
2015-10-14
Completion date
2020-03-23
Last updated
2022-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSD, Meditation, Yoga, Cognitive Therapy

Brief summary

Post traumatic stress disorder (PTSD) is a condition that develops as a result of exposure to a traumatic event. The purpose of this study is to determine whether a breathing meditation technique (Sudarshan Kriya Yoga; SKY) provides a treatment benefit that is as effective as the standard intervention. Patients' PTSD symptoms will be monitored before treatment, at the end of treatment, one month after treatment and 12 months after treatment.

Detailed description

Post traumatic stress disorder (PTSD) is a condition that develops as a result of exposure to a traumatic event and is characterized by intense physiological and psychological reactivity to stimuli associated with that trauma. PTSD represents a substantial proportion of the burden of illness among Veterans. A recent study found that PTSD was diagnosed in 13% of Veterans returning from Iraq and Afghanistan. Recent reports have also highlighted that PTSD is associated with suicidality - a fact that may explain the alarming rise of suicidal behavior amongst returning Veterans. Several studies suggest that meditation-based treatments may be helpful in treating PTSD. Sudarshan Kriya Yoga (SKY) is a meditation technique that involves a sequence of breathing exercises and has shown promise in treating PTSD. There are several lines of evidence to suggest that such meditation techniques provide a solid foundation for treating PTSD. First, breathing meditation techniques offer a powerful method for balancing autonomic nervous system activity that is often heightened in PTSD. Second, they promote the relaxation response that counters hyperarousal and results in a calmer approach to difficulties and challenges. Third, they may improve sleep quality. This may be important in treating PTSD because memories are encoded into long-term storage during sleep via a process known as consolidation. It is possible that the disturbed sleep which is common in PTSD (nightmares and insomnia) lead to disrupted memory consolidation. Therefore improvement in sleep may lead to improvement in PTSD. Despite promising findings, meditation has not been sufficiently studied in Veterans to recommend its widespread use in treating PTSD. The goal of this proposal is to examine the effects of SKY meditation therapy on Veterans with clinically significant PTSD symptoms. SKY intervention will be compared to cognitive processing therapy (CPT) that is commonly used to treat Veterans with PTSD. CPT will be given as a cognitive only version (CPT-C) which is efficacious in treating PTSD. Veterans will be randomly assigned to one of the two groups (SKY, CPT-C; n=38 per group) and treatment will be delivered over a six-week period. A noninferiority experimental design will be used as is appropriate for trials in which the primary objective is to show that a novel intervention (SKY) is as effective as the standard intervention. Patients' PTSD symptoms will be monitored across time; before treatment (i.e., baseline), at the end of treatment, one month after treatment and 12 months after treatment. Other measures will be taken at baseline and at the end of treatment, and will include autonomic arousal (heart rate) and cognitive functioning including memory consolidation. The investigators will also monitor dropout rates as these can be high in conventional PTSD treatment programs. Based on preliminary studies using SKY in Veterans with PTSD and the existing literature, the investigators expect that PTSD symptom severity will be reduced following treatment with SKY, that this effect will not be clinically inferior to CPT-C and that the dropout rates will be no higher than CPT-C. Such findings would provide strong evidence for the efficacy of SKY in treating Veterans with PTSD. The investigators also expect that improvements in clinical measures of PTSD will correlate with improvements in memory consolidation, reflecting improvements in sleep following treatment. It is also likely that the individual's response to treatment will be influenced by their baseline characteristics. The SKY and CBT-C interventions focus on different aspects of PTSD; the SKY intervention focuses on breathing and relaxation techniques whereas CPT-C focuses on modifying the understanding of trauma through cognitive restructuring. For this reason the SKY intervention may be more effective for Veterans who have exaggerated arousal (e.g. heightened heart rate). In contrast the CPT-C intervention may be more effective for Veterans who have more cognitive symptoms (e.g., flashbacks, attentional difficulties) since CPT-C addresses cognitive processes. The long term goal of this project is to conduct a fully-powered multi-center randomized controlled clinical trial of SKY meditation in Veterans.

Interventions

BEHAVIORALSKY 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.

BEHAVIORALCPT-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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Veteran from any conflict era * Symptoms of Posttraumatic Stress Disorder measured during study screening (scoring ≥38 on the PCL-5)

Exclusion criteria

* planning on starting a new course of behavioral therapy during the trial * started new medication for PTSD within 8 weeks of the study screening * participation in another study * mania or psychosis within the past 6 months * suicidal or homicidal intent within the past 60 days * substance dependence (other than nicotine) within the past 30 days, * seizure disorder * severe traumatic brain injury

Design outcomes

Primary

MeasureTime frameDescription
Change in PTSD Checklist (PCL)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.

Secondary

MeasureTime frameDescription
Change in Beck Depression Inventory II (BDI-II)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.
Change in Positive and Negative Affect Schedule (PANAS)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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
41
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.
44
Total85

Baseline characteristics

CharacteristicSudarshan Kriya YogaTotalCPT-C
Age, Continuous56.9 years
STANDARD_DEVIATION 13.6
56.6 years
STANDARD_DEVIATION 12.7
56.2 years
STANDARD_DEVIATION 11.7
Ethnicity (NIH/OMB)
Hispanic or Latino
26 Participants57 Participants31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants20 Participants9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants8 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants5 Participants4 Participants
Race (NIH/OMB)
Black or African American
8 Participants13 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
9 Participants15 Participants6 Participants
Race (NIH/OMB)
White
23 Participants52 Participants29 Participants
Region of Enrollment
United States
41 participants85 participants44 participants
Sex: Female, Male
Female
7 Participants10 Participants3 Participants
Sex: Female, Male
Male
34 Participants75 Participants41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 410 / 44
other
Total, other adverse events
0 / 411 / 44
serious
Total, serious adverse events
0 / 411 / 44

Outcome results

Primary

Change in PTSD Checklist (PCL)

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.

Time frame: baseline, after treatment (six weeks), one month after treatment, and one year after treatment

ArmMeasureGroupValue (MEAN)Dispersion
Sudarshan Kriya YogaChange in PTSD Checklist (PCL)change from baseline to end of treatment-5.6 score on a scaleStandard Deviation 9.5
Sudarshan Kriya YogaChange in PTSD Checklist (PCL)change from baseline to one month after treatment-4.8 score on a scaleStandard Deviation 10.5
Sudarshan Kriya YogaChange in PTSD Checklist (PCL)change from baseline to one year after treatment-4.4 score on a scaleStandard Deviation 11.4
CPT-CChange in PTSD Checklist (PCL)change from baseline to end of treatment-6.8 score on a scaleStandard Deviation 11.4
CPT-CChange in PTSD Checklist (PCL)change from baseline to one month after treatment-6.8 score on a scaleStandard Deviation 11.9
CPT-CChange in PTSD Checklist (PCL)change from baseline to one year after treatment-6.2 score on a scaleStandard Deviation 10.7
Secondary

Change in Beck Depression Inventory II (BDI-II)

The 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.

Time frame: baseline, after treatment (six weeks), one month after treatment, and one year after treatment

ArmMeasureGroupValue (MEAN)Dispersion
Sudarshan Kriya YogaChange in Beck Depression Inventory II (BDI-II)Change from baseline to end of treatment-6.1 score on a scaleStandard Deviation 6.8
Sudarshan Kriya YogaChange in Beck Depression Inventory II (BDI-II)Change from baseline to one month after treatment-4.7 score on a scaleStandard Deviation 8.7
Sudarshan Kriya YogaChange in Beck Depression Inventory II (BDI-II)Change from baseline to one year after treatment-5.6 score on a scaleStandard Deviation 9.6
CPT-CChange in Beck Depression Inventory II (BDI-II)Change from baseline to end of treatment-3.6 score on a scaleStandard Deviation 10.9
CPT-CChange in Beck Depression Inventory II (BDI-II)Change from baseline to one month after treatment-2.8 score on a scaleStandard Deviation 11.7
CPT-CChange in Beck Depression Inventory II (BDI-II)Change from baseline to one year after treatment-4.5 score on a scaleStandard Deviation 10
Secondary

Change in Positive and Negative Affect Schedule (PANAS)

A 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.

Time frame: baseline, after treatment (six weeks), one month after treatment, and one year after treatment

ArmMeasureGroupValue (MEAN)Dispersion
Sudarshan Kriya YogaChange in Positive and Negative Affect Schedule (PANAS)PANAS positive: change from baseline to end of treatment2.5 score on a scaleStandard Deviation 5.8
Sudarshan Kriya YogaChange in Positive and Negative Affect Schedule (PANAS)PANAS positive: change from baseline to one month after treatment1.3 score on a scaleStandard Deviation 8.6
Sudarshan Kriya YogaChange in Positive and Negative Affect Schedule (PANAS)PANAS positive: change from baseline to one year after treatment-0.1 score on a scaleStandard Deviation 10.5
Sudarshan Kriya YogaChange in Positive and Negative Affect Schedule (PANAS)PANAS negative: change from baseline to end of treatment-3.2 score on a scaleStandard Deviation 4.6
Sudarshan Kriya YogaChange in Positive and Negative Affect Schedule (PANAS)PANAS negative: change from baseline to one month after treatment-2.9 score on a scaleStandard Deviation 6.7
Sudarshan Kriya YogaChange in Positive and Negative Affect Schedule (PANAS)PANAS negative: change from baseline to one year after treatment-1.8 score on a scaleStandard Deviation 8.2
CPT-CChange in Positive and Negative Affect Schedule (PANAS)PANAS negative: change from baseline to one month after treatment-1.2 score on a scaleStandard Deviation 8.4
CPT-CChange in Positive and Negative Affect Schedule (PANAS)PANAS positive: change from baseline to end of treatment0.3 score on a scaleStandard Deviation 5.9
CPT-CChange in Positive and Negative Affect Schedule (PANAS)PANAS negative: change from baseline to end of treatment-0.9 score on a scaleStandard Deviation 8.8
CPT-CChange in Positive and Negative Affect Schedule (PANAS)PANAS positive: change from baseline to one month after treatment-1.3 score on a scaleStandard Deviation 7.1
CPT-CChange in Positive and Negative Affect Schedule (PANAS)PANAS negative: change from baseline to one year after treatment-1.7 score on a scaleStandard Deviation 8
CPT-CChange in Positive and Negative Affect Schedule (PANAS)PANAS positive: change from baseline to one year after treatment0.4 score on a scaleStandard Deviation 7

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026