NCT02366403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

October 14, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 19, 2021

Completed
Last Updated

July 12, 2022

Status Verified

June 1, 2022

Enrollment Period

4.4 years

First QC Date

January 12, 2015

Results QC Date

February 25, 2021

Last Update Submit

June 15, 2022

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSDMeditationYogaCognitive Therapy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

  • Change in Beck Depression Inventory II (BDI-II)

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

  • Change in Positive and Negative Affect Schedule (PANAS)

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

Study Arms (2)

SKY

EXPERIMENTAL

a standardized meditation program

Behavioral: SKY meditation

CPT-C

ACTIVE COMPARATOR

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

Interventions

SKY meditationBEHAVIORAL

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.

SKY
CPT-CBEHAVIORAL

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.

Also known as: Cognitive Processing Therapy
CPT-C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

Related Publications (5)

  • 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.

    PMID: 40224604DERIVED

  • 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.

    PMID: 38389985DERIVED

  • 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.

    PMID: 36008059DERIVED

  • 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.

    PMID: 35428258DERIVED

  • 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.

    PMID: 30948610DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Limitations and Caveats

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

Results Point of Contact

Title
Peter Bayley, PhD
Organization
War Related Illness and Injury Study Center, VA Palo Alto Healthcare System
peter.bayley@va.gov
650 493-5000

Study Officials

  • Peter J Bayley, PhD

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2015

First Posted

February 19, 2015

Study Start

October 14, 2015

Primary Completion

March 23, 2020

Study Completion

March 23, 2020

Last Updated

July 12, 2022

Results First Posted

April 19, 2021

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
05/01/2020

Locations

US(1)