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Trial record 13 of 39 for:    diabetes AND heart disease | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

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 : Recruiting
First Posted : December 29, 2015
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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:

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 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
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Determine the effectiveness of TSY compared to CPT-C in reducing PTSD symptoms, chronic pain, and insomnia [ Time Frame: 3 years ]
    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.

  2. To evaluate the effectiveness of TSY as compared to CPT-C in improving quality of life and social functioning in women Veterans with PTSD related to MST. [ Time Frame: 3 years ]
    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.

  3. To evaluate the effectiveness of TSY as compared to CPT-C on biological stress response and psychophysiological hyper-responsivity. [ Time Frame: 3 years ]
    Participants in the TSY group will show statistically and clinically meaningful changes in biological stress response (inflammatory cytokines, C-reactive protein levels) and psychophysiological hyper-responsivity (dark-enhanced startle measures and heart rate variability).

  4. PTSD Checklist-5 (PCL-5) [ Time Frame: Baseline; Mid-Treatment; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
    The PCL-5 is a 17-item self-report rating-scale instrument that parallels diagnostic criteria for PTSD, as delineated in the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). The PCL is the standard measure of PTSD symptoms in the VA and can be used to determine PTSD diagnosis and PTSD symptom severity.


Secondary Outcome Measures :
  1. PROMIS v2.0 Ability to Participate in Social Roles and Activities - Short Form 4a [ Time Frame: Baseline; Mid-Treatment; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]

    The PROMIS instruments use modern measurement theory to reliably and validly assess patient-reported outcomes (PROs) for clinical research and practice.

    This measure contains 4 items assessing perceived ability to perform one's usual social roles and activities.


  2. PROMIS v2.0 Social Isolation - Short Form 4a [ Time Frame: Baseline; Mid-Treatment; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
    This measure contains 4 items assessing perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others.

  3. PROMIS v2.0 Satisfaction with Social Roles and Activities - Short Form 4a [ Time Frame: Baseline; Mid-Treatment; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
    This measure contains 4 items assessing satisfaction with performing one's usual social roles and activities (e.g., "I am satisfied with my ability to participate in family activities").

  4. PROMIS v2.0 Emotional Support - Short Form 4a [ Time Frame: Baseline; Mid-Treatment; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
    This measure contains 4 items assessing perceived feelings of being cared for and valued as a person; having confidant relationships.

  5. Interleukin-6 (IL-6) levels from plasma [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
    Elevations in pro-inflammatory cytokines, including IL-6, (IL-1 , IL-2, IL-6, TNF- ) and C-reactive protein 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.

  6. Interleukin-10 (IL-10) levels from plasma [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
    Elevations in pro-inflammatory cytokines, including IL-10, have been shown to correlate with increasing pain intensity in patients with chronic pain, psychological stress, and PTSD. In addition, IL-10 has been established as part of the biochemical sleep regulatory process.

  7. C-Reactive Protein (CRP) levels from plasma [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
    C-reactive protein is an inflammatory marker. 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.

  8. Dark-Enhanced Startle Response [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
    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.

  9. Heart Rate Variability [ Time Frame: Baseline; 2-Weeks Post-Treatment; 3-Months Post-Treatment ]
    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.



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)

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


Contacts
Contact: Ashley S Mccullough, MSW BS (404) 321-6111 ext 7026 sharon.mccullough@va.gov
Contact: Ursula A Kelly, PhD MSN BA (404) 321-6111 ext 2340 Ursula.Kelly@va.gov

Locations
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Ashley S Mccullough, MSW BS    (404) 321-6111 ext 7026    sharon.mccullough@va.gov   
Contact: Ursula A Kelly, PhD MSN BA    (404) 321-6111 ext 2340    Ursula.Kelly@va.gov   
Principal Investigator: Ursula Ann Kelly, PhD MSN BA         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Ursula Ann Kelly, PhD MSN BA Atlanta VA Medical and Rehab Center, Decatur, GA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02640690     History of Changes
Other Study ID Numbers: NRI 15-151
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders