Breathing Meditation Intervention for Post Traumatic Stress Disorder

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02366403
Collaborator
(none)
85
Enrollment
1
Location
2
Arms
53.3
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: SKY meditation
  • Behavioral: CPT-C
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Breathing Meditation Intervention for Post-Traumatic Stress Disorder
Actual Study Start Date :
Oct 14, 2015
Actual Primary Completion Date :
Mar 23, 2020
Actual Study Completion Date :
Mar 23, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: SKY

a standardized meditation program

Behavioral: 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.

Active Comparator: 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.

Behavioral: 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.
Other Names:
  • Cognitive Processing Therapy
  • Outcome Measures

    Primary Outcome Measures

    1. Change in PTSD Checklist (PCL) [baseline, six weeks]

      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.

    Secondary Outcome Measures

    1. Change in Beck Depression Inventory II (BDI-II) [baseline, six weeks, one month]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Veteran from any conflict era

    • Symptoms of Posttraumatic Stress Disorder measured during study screening

    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1VA Palo Alto Health Care System, Palo Alto, CAPalo AltoCaliforniaUnited States94304-1290

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Peter J Bayley, PhD, VA Palo Alto Health Care System, Palo Alto, CA

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT02366403
    Other Study ID Numbers:
    • D1485-R
    • IRX001485A
    First Posted:
    Feb 19, 2015
    Last Update Posted:
    May 11, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by VA Office of Research and Development
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleSudarshan Kriya YogaCPT-C
    Arm/Group Descriptiona 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 (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.
    Period Title: Overall Study
    STARTED4144
    COMPLETED3029
    NOT COMPLETED1115

    Baseline Characteristics

    Arm/Group TitleSudarshan Kriya YogaCPT-CTotal
    Arm/Group Descriptiona 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 (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.Total of all reporting groups
    Overall Participants414485
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    56.9
    (13.6)
    56.2
    (11.7)
    56.6
    (12.7)
    Sex: Female, Male (Count of Participants)
    Female
    7
    17.1%
    3
    6.8%
    10
    11.8%
    Male
    34
    82.9%
    41
    93.2%
    75
    88.2%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    26
    63.4%
    31
    70.5%
    57
    67.1%
    Not Hispanic or Latino
    11
    26.8%
    9
    20.5%
    20
    23.5%
    Unknown or Not Reported
    4
    9.8%
    4
    9.1%
    8
    9.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    2.4%
    4
    9.1%
    5
    5.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    8
    19.5%
    5
    11.4%
    13
    15.3%
    White
    23
    56.1%
    29
    65.9%
    52
    61.2%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    9
    22%
    6
    13.6%
    15
    17.6%
    Region of Enrollment (participants) [Number]
    United States
    41
    100%
    44
    100%
    85
    100%

    Outcome Measures

    1. Primary Outcome
    TitleChange in PTSD Checklist (PCL)
    DescriptionPosttraumatic 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 Framebaseline, six weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleSudarshan Kriya YogaCPT-C
    Arm/Group Descriptiona 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 (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.
    Measure Participants4144
    Mean (Standard Deviation) [score on a scale]
    -5.6
    (9.5)
    -6.8
    (11.4)
    2. Secondary Outcome
    TitleChange in Beck Depression Inventory II (BDI-II)
    DescriptionThe 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 Framebaseline, six weeks, one month

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleSudarshan Kriya YogaCPT-C
    Arm/Group Descriptiona 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 (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.
    Measure Participants4144
    Change from baseline to week 6
    -6.1
    (6.8)
    -3.6
    (10.9)
    Change from baseline to one month after treatment
    -4.7
    (8.7)
    -2.8
    (11.7)

    Adverse Events

    Time Framebaseline to one year posttreatment (i.e. 58 weeks)
    Adverse Event Reporting Description Study staff conducted safety evaluations and followed safety protocols whenever a participant endorsed any suicidal or homicidal ideation, including via self report measures.
    Arm/Group TitleSudarshan Kriya YogaCPT-C
    Arm/Group Descriptiona 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 (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.
    All Cause Mortality
    Sudarshan Kriya YogaCPT-C
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/41 (0%) 0/44 (0%)
    Serious Adverse Events
    Sudarshan Kriya YogaCPT-C
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/41 (0%) 1/44 (2.3%)
    Psychiatric disorders
    Admission to inpatient psychiatry0/41 (0%) 01/44 (2.3%) 1
    Other (Not Including Serious) Adverse Events
    Sudarshan Kriya YogaCPT-C
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/41 (0%) 1/44 (2.3%)
    Psychiatric disorders
    Distressed and lost to follow up0/41 (0%) 01/44 (2.3%) 1

    Limitations/Caveats

    SKY involved more hours of instruction than CPT (25 vs 12 hours).

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitlePeter Bayley, PhD
    OrganizationWar Related Illness and Injury Study Center, VA Palo Alto Healthcare System
    Phone650 493-5000 ext 68653
    Emailpeter.bayley@va.gov
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT02366403
    Other Study ID Numbers:
    • D1485-R
    • IRX001485A
    First Posted:
    Feb 19, 2015
    Last Update Posted:
    May 11, 2021
    Last Verified:
    Apr 1, 2021