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Stress Disorders, Post-TraumaticNCT02366403

Breathing Meditation Intervention for Post Traumatic Stress Disorder

A study testing SKY meditation and CPT-C in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stress Disorders, Post-Traumatic
What is being tested?
SKY meditation and CPT-C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
14 Oct 2015to 23 Mar 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1290

Other trials in United States

About this study

Official title: Breathing Meditation Intervention for Post-Traumatic Stress Disorder

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.

Read the 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.

Being tested
SKY meditation, CPT-C
Keywords
PTSD, Meditation, Yoga, Cognitive Therapy
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SKY meditationBehavioural

    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-CBehavioural

    Also called Cognitive Processing Therapy

    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.

Study groups in NCT02366403
Study groupRoleWhat they receive
SKYExperimentala standardized meditation program
Receives: Behavioral: SKY meditation
CPT-CActive comparatorCPT-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.
Receives: Behavioral: CPT-C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (2)
  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2015 (estimated)
  2. Study start14 Oct 2015
  3. Primary completion23 Mar 2020
  4. Study completion23 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02366403
Sponsor's protocol ID
D1485-R
Other IDs
IRX001485A
Status last verified
Jun 2022
First submitted
12 Jan 2015
Last updated
12 Jul 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Mathersul DC, Schulz-Heik RJ, Avery TJ, Allende S, Zeitzer JM, Bayley PJ. US Veterans Show Improvements in Subjective but Not Objective Sleep following Treatment for Posttraumatic Stress Disorder: Secondary Analyses from a Randomised Controlled Trial. Depress Anxiety. 2023 Aug 14;2023:7001667. doi: 10.1155/2023/7001667. eCollection 2023.

    PubMed 40224604
  • Mathersul DC, Zeitzer JM, Schulz-Heik RJ, Avery TJ, Bayley PJ. Emotion regulation and heart rate variability may identify the optimal posttraumatic stress disorder treatment: analyses from a randomized controlled trial. Front Psychiatry. 2024 Feb 8;15:1331569. doi: 10.3389/fpsyt.2024.1331569. eCollection 2024.

    PubMed 38389985
  • Bayley PJ, Schulz-Heik RJ, Tang JS, Mathersul DC, Avery T, Wong M, Zeitzer JM, Rosen CS, Burn AS, Hernandez B, Lazzeroni LC, Seppala EM. Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans. BMJ Open. 2022 Aug 25;12(8):e056609. doi: 10.1136/bmjopen-2021-056609.

    PubMed 36008059
  • Mathersul DC, Dixit K, Schulz-Heik RJ, Avery TJ, Zeitzer JM, Bayley PJ. Emotion dysregulation and heart rate variability improve in US veterans undergoing treatment for posttraumatic stress disorder: Secondary exploratory analyses from a randomised controlled trial. BMC Psychiatry. 2022 Apr 15;22(1):268. doi: 10.1186/s12888-022-03886-3.

    PubMed 35428258
  • Mathersul DC, Tang JS, Schulz-Heik RJ, Avery TJ, Seppala EM, Bayley PJ. Study protocol for a non-inferiority randomised controlled trial of SKY breathing meditation versus cognitive processing therapy for PTSD among veterans. BMJ Open. 2019 Apr 3;9(4):e027150. doi: 10.1136/bmjopen-2018-027150.

    PubMed 30948610

Questions about this trial

What is this clinical trial studying?

A study testing SKY meditation and CPT-C in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PTSD Checklist (PCL) (time frame: baseline, after treatment (six weeks), one month after treatment, and one year after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02366403, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.

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