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Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma (PSL II)

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ClinicalTrials.gov Identifier: NCT02640690
Recruitment Status : Active, not recruiting
First Posted : December 29, 2015
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
In this study, we are evaluating the effectiveness of a yoga intervention to treat posttraumatic stress disorder (PTSD), its associated symptoms of chronic pain and insomnia, and biological and physiological responses to trauma and PTSD in women Veterans who experienced military sexual trauma (MST). If effective, this yoga intervention could reduce PTSD symptoms and chronic pain, improve sleep quality, and decrease the body's automatic "fight or flight" stress response and the damage this stress response causes in the body, including heart disease and diabetes. This intervention could improve these women Veterans' quality of life and social functioning, for example, going to work and having satisfying relationships with family and friends. This study may support an innovative, complementary and alternative PTSD treatment for women Veterans who experienced MST. This new, evidence-based PTSD treatment could supplement current PTSD treatments. Clinical guidelines for this yoga intervention could be implemented nationally in the VA health care system.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-traumatic Behavioral: Trauma Sensitive Yoga Intervention Behavioral: Cognitive Processing Therapy-Cognitive Only Not Applicable

Detailed Description:

Note: Recruitment has been suspended because of COVID related restrictions and limitations imposed on data collection

Objectives: The overall goal of this project is to maximize the health, social functioning, and quality of life of women Veterans with posttraumatic stress disorder (PTSD) who have experienced military sexual trauma (MST). The specific aims of this randomized controlled trial (RCT) are to evaluate the effectiveness of a trauma-sensitive yoga intervention designed specifically for women who experienced sexual trauma as compared to a gold-standard PTSD treatment, Cognitive Processing Therapy-Cognitive, to 1) treat PTSD and its co-morbid symptoms of chronic pain and insomnia, 2) improve social functioning and quality of life, and 3) reduce the biological and psychophysiologic responses associated with PTSD in women Veterans who experienced MST.

Research Plan: This four year RCT is the next step following the NRI Pilot Study (NRI 12-417) in which the investigators demonstrated the feasibility of recruitment, retention, randomization, intervention implementation, and data collection, including biological and psychophysiological data. Women Veterans seeking treatment for PTSD who report chronic pain and insomnia are being recruited from the Atlanta VAMC Trauma Recovery Program Women's Trauma Program. Participants (n=210) will be randomly assigned to trauma-sensitive yoga (10 weekly sessions) or Cognitive Processing Therapy-Cognitive (12 weekly sessions); both intervention protocols are data-driven. The target enrollment sample size is 210, with a target final sample of 100 or more. The investigators are conservatively allowing for 50%-60% retention, based on pilot study results.

Methods: Data Collection: Data are collected at four points, baseline through 3-months post-intervention. Outcome measures include self-report, clinical assessments and biologic and psychophysiologic markers. Specific outcomes include PTSD symptom severity, chronic pain, insomnia, social functioning, quality of life, cytokines (IL-6, IL-10), C-reactive protein, dark-enhanced startle, and heart rate variability. Data Analysis: Comparisons between the groups at baseline will be run using t-tests, Mann Whitney non-parametric tests, and chi-square tests as appropriate. Multilevel mixed models (MLM) will be used to analyze the differences between the groups over time. MLM adjusts for attrition (missing data) over time and applies appropriate correlation structure between the time points.

Clinical Relevance: Women Veterans experience MST and PTSD at alarming rates; consistently reported prevalence rates for both among VHA patient samples are 20% or more. MST and PTSD put this population at risk for significant physical and mental health symptoms, including chronic pain, suicide, and negative health behaviors. This RCT may provide sufficient evidence to support an innovative, complementary and alternative PTSD treatment for women Veterans who experienced MST. The positive effects of reducing distressing symptoms and PTSD-related psychophysiological stress would likely improve social functioning and quality of life and minimize the significant medical consequences of PTSD in this population. This new, evidence-based PTSD treatment could supplement existing evidence-based PTSD treatment modalities. Clinical guidelines for this innovative intervention based on evidence from this clinical trial could be disseminated to and implemented in VA Medical Centers nationwide.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trauma-sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : February 26, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Trauma-Sensitive Yoga (TSY) Intervention
10-weekly 1-hour TSY Sessions
 Behavioral: Trauma Sensitive Yoga Intervention
(10) 1-hour sessions of trauma sensitive yoga
Active Comparator: Cognitive Processing Therapy-Cognitive Intervention (CPT-C)
12-weekly 1.5 hour CPT-C Sessions
 Behavioral: Cognitive Processing Therapy-Cognitive Only
(12) 1.5 hour sessions of cognitive processing therapy


Outcome Measures
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Primary Outcome Measures :
  1. Determine the effectiveness of TSY compared to CPT-C over time in reducing PTSD symptoms, chronic pain, and insomnia [ Time Frame: Baseline; Mid-Treatment (TSY, 5 weeks: CPT, 6 weeks); 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
    Participants in the TSY group will show statistically and clinically meaningful reductions in PTSD symptoms, chronic pain and insomnia (PTSD Checklist-5 (PCL-5) scores, Clinician Administered PTSD Scale (CAPS) scores, Pain Outcomes Questionnaire (POQ) scores, Pittsburgh Sleep Quality Index (PSQI) scores) compared to CPT-C group results following treatment.


Secondary Outcome Measures :
  1. To evaluate the effectiveness of TSY as compared to CPT-C over time in alterations in C-reactive proteins. [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]

    Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (C-reactive protein).

    Alterations in C-reactive protein is associated with symptoms that commonly co-occur with PTSD, including depressive symptoms, fatigue, chronic tissue inflammation, and enhanced sensitivity to pain.

    -Blood samples will collected and analyzed by a laboratory.


  2. To evaluate the effectiveness of TSY as compared to CPT-C over time in parasympathetic and sympathetic nervous systems [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]

    Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (nervous system).

    Heart rate variability reflects the central nervous system's ability to respond immediately to fluctuations in blood pressure occurring with each beat. Decreased heart rate variability has been correlated with morbidity and mortality from diverse diseases, including anxiety and depression and cardiovascular disease.

    - Electrocardiographic monitoring of the R-R interval using portable recording device.


  3. To evaluate the effectiveness of TSY as compared to CPT-C over time in levels of fear and anxiety. [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]

    Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (acoustic startle response).

    - BIOPAC MP150 Psychophysiological Recording System

    Dark-enhanced startle is an ecologically valid psychophysiological paradigm for assessing contextual levels of fear and anxiety. Dark-enhanced startle is a laboratory analogue of sustained anxiety and represents a clinically useful tool for assessing anxiety-like behaviors and hyperarousal as they relate to symptom severity.


  4. To evaluate the effectiveness of TSY as compared to CPT-C over time in autonomic electrocardiogram markers (QT interval). [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]

    Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (autonomic ECG markers).

    - 12-lead electrocardiogram


  5. To evaluate the effectiveness of TSY as compared to CPT-C over time in improving quality of life and social functioning in women Veterans with PTSD related to MST. [ Time Frame: Baseline; Mid-Treatment (TSY, 5 weeks: CPT, 6 weeks); 2-Weeks Post-Treatment; 3-Months Post-Treatment ]

    Participants in the TSY group will show statistically and clinically meaningful improvements in quality of life and social functioning (PROMIS measures) compared to CPT-C group results.

    - PROMIS v2.0 (Short Forms 4a) Ability to Participate in Social Roles and Activities, Social Isolation, Satisfaction with Social Roles and Activities, and Emotional Support.


  6. To evaluate the effectiveness of TSY as compared to CPT-C over time in elevations in pro-inflammatory cytokines. [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]

    Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (inflammatory cytokines).

    Elevations in pro-inflammatory cytokines, including IL-6, (IL-1 , IL-2, IL-6, TNF- ) and IL-10, have been shown to correlate with increasing pain intensity in patients with chronic pain, psychological stress, and PTSD. IL-6 has been shown to act as a messenger relaying chemotactic peripheral immune signals to the central nervous system. In addition, IL-6 has been established as part of the biochemical sleep regulatory process.

    • Blood samples will collected and analyzed by a laboratory.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women Veterans who experienced MST
  • Diagnosed with PTSD related to MST
  • Insomnia
  • Willing to participate in either TC-TSY or CPT-C study intervention

Exclusion Criteria:

  • Schizophrenia with significant psychotic symptoms
  • Current, active suicidal intent or plan
  • Current substance abuse or dependence

  • Certain medical conditions that can contribute significantly to psychiatric symptoms, including:

    • poorly controlled hypo/hyperthyroidism
    • kidney or liver failure
  • Dementia
  • Moderate or severe traumatic brain injury (TBI) or other cognitive impairment sufficient to interfere with ability to give informed consent
  • Pain due to acute injury (<3 months), post-surgical pain (<3 months) or pain due to malignancy; pain related to injury and surgery are excluded to reduce risk of exacerbating underlying injury
  • Receiving mental health treatment outside of the VA
  • Ongoing participation in mental health treatment at odds with study intervention (For Example: yoga, trauma-focused treatment)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640690


Locations
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United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
United States, Oregon
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Ursula Ann Kelly, PhD MSN BA Atlanta VA Medical and Rehab Center, Decatur, GA
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02640690    
Other Study ID Numbers: NRI 15-151
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Stress Disorders, Post-traumatic
Yoga
Cognitive Therapy
Chronic Pain
 Veterans
cytokines
acoustic startle reflex
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders