Stress Disorders, Post-traumaticPSLIINCT02640690
Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma
A study testing Trauma Center Trauma Sensitive Yoga Intervention (TCTSY) and Cognitive Processing Therapy in people with Stress Disorders, Post-traumatic, run by VA Office of Research and Development at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Disorders, Post-traumatic
- What is being tested?
- Trauma Center Trauma Sensitive Yoga Intervention (TCTSY) and Cognitive Processing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2016to 30 Sep 2021
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women Veterans who experienced MST
- Diagnosed with PTSD related to MST
- Insomnia
- Willing to participate in either TCTSY or CPT study intervention
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
Official title: Trauma-sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma
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.
Read the 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, 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 five 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 were recruited from a primary site (southeast US) and second site (northwest US) and were randomized to Trauma Center Trauma-Sensitive Yoga (TCTSY) (10 weekly sessions) or Cognitive Processing Therapy (CPT) (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, heart rate variability, and dark-enhanced startle. 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.
- Conditions
- Stress Disorders, Post-traumatic
- Being tested
- Trauma Center Trauma Sensitive Yoga Intervention (TCTSY), Cognitive Processing Therapy
- Keywords
- Stress Disorders, Post-traumatic, Yoga, Cognitive Therapy, Chronic Pain, Veterans, cytokines, acoustic startle reflex, women, heart rate variability, sexual trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Chronic Pain, Sexual Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Center Trauma Sensitive Yoga Intervention (TCTSY)Behavioural
(10) 1-hour sessions of trauma sensitive yoga
Cognitive Processing TherapyBehavioural
Also called Cognitive Processing Therapy-Cognitive
(12) 1.5 hour sessions of cognitive processing therapy
| Study group | Role | What they receive |
|---|---|---|
| Trauma Center Trauma-Sensitive Yoga (TCTSY) | Experimental | 10-weekly 1-hour TCTSY Sessions Receives: Behavioral: Trauma Center Trauma Sensitive Yoga Intervention (TCTSY) |
| Cognitive Processing Therapy (CPT) | Active comparator | 12-weekly 1.5 hour CPT Sessions Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention
Clinician-Administered PTSD Scale for DSM-5 also known as CAPS-5 is the gold standard in PTSD assessment. The CAPS-5 is a structured interview that was used to assess current (past month) PTSD symptom severity. The CAPS-5 total symptom severity score is the sum of 20 items, each scored 0-4, to yield a score with a possible range of 0-80. Higher scores mean worse outcome.
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
PTSD Symptom Checklist-5 (PCL-5): Change in Mean Total Score From Baseline to 3-month Post-intervention
The PTSD Symptom-Checklist -Version 5 (PCL-5) is a 20-item, self-report instrument that assesses the presence and severity of DSM-V PTSD symptoms in the last month. It was summed for a total severity score ranging from 0-80, with higher scores representing greater symptom severity (worse outcomes). Within group changes in mean total PCL-5 score from baseline to 3-month post-intervention are reported here.
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
Secondary outcomes (14)
Health-related Quality of Life: VR12, Mental Component Summary (MCS): Change in Mean MCS From Baseline to 3-month Post-intervention
The VR-12 is a12-item self-rating scale that assess health-related quality of life in veterans and includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of two meta-scores: the Mental Component Summary and the Physical Component Summary. The Mental Component Score (MCS) measures mental aspects of quality of life and ranges from 0 (extremely poor mental health) to 100 (extremely good mental health). The VR-12 is veteran population-normed with each component to have a mean score of 50 and a standard deviation of 10. Scores greater than 50 represent above average health status (better outcomes). The change in the mean MCS from baseline to 3-months post-treatment are presented here.
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
Health-related Quality of Life: VR12, Physical Component: Change in Mean Subscale Score From Baseline to 3-month Post-intervention
The VR-12 is a 12-item self-rating scale that assess health-related quality of life in veterans and includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of two meta-scores: the Physical Component Summary and the Mental Component Summary. The Physical Component Score (PCS) measures physical aspects of quality of life and ranges from 0 (extremely poor physical health) to 100 (extremely good physical health), thus has a possible range of 0-100. The VR-12 is veteran population-normed with each component to have a mean score of 50 and a standard deviation of 10. Scores greater than 50 represent above average health status (better outcomes).
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
BPI Pain Severity: Change in Total Severity Score From Baseline to 3-months Post-intervention
The Brief Pain Inventory (BPI) contains three questions regarding pain severity. Pain severity is measured according to the worst pain experienced in the last three days, average pain in the last three days, and current pain; with each rated on an ordinal scale from "0" = "no pain" to "10" = "pain as bad as you can imagine." The pain severity score is the mean of the three pain severity item scores, with a potential range of 0-10; higher scores indicate worse outcomes.
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
BPI Pain Interference: Change in Total Interference Score From Baseline to 3-months Post-intervention
The Brief Pain Inventory (BPI) contains seven questions regarding pain interference that are rated on an ordinal numerical scale with anchors of 0 (no pain/interference) to 10 (maximum pain/interference). Pain interference assesses how that pain has affected general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. The pain interference score is the mean of the seven pain interference item scores, with a potential range of 0-10; higher scores indicate worse outcomes.
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
Changes in C-reactive Proteins (CRP) From Baseline to 3-months Post-intervention; Within Group Changes; Primary Site Only
C-reactive protein (CRP) is a non-specific marker of inflammation. Blood samples of 25 ml were drawn into EDTA-containing (purple top) tubes and stored in a -80o freezer until analysis. The normal range is 8-10 mg/L. Higher levels of CRP indicate worse outcomes. The unit of analysis is the natural log (LN) of raw data (mg/L).
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in IL-6 Pro-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only
IL-6 is a pro-inflammatory cytokine. Blood samples of 25 ml were drawn into EDTA-containing (purple top) tubes and stored in a -80o freezer until analysis. The normal range is < 5.0 pg/mL. Higher values indicate more inflammation (worse outcomes). The unit of analysis in these results is the natural log (LN) of the value (pg/mL).
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in IL-10 Anti-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only
IL-10 is an anti-inflammatory cytokine. Blood samples of 25 ml were drawn into EDTA-containing (purple top) tubes and stored in a -80o freezer until analysis. The range of normal values is 4.8 - 9.8 pg/mL. Values out of range can indicate inflammatory dysregulation.
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the Beck Depression Inventory-II (BDI-II) Total Score From Baseline to 3-months Post-intervention (Within Group)
The Beck Depression Inventory II (BDI-II) is a 21-question multiple-choice self-report inventory widely used for assessing the severity of depression. The BDI-II total score is the sum of the 21 items, with a possible range of 0-63. Higher scores indicate worse outcomes.
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the Difficulties in Emotion Regulation Scale (DERS) Total Score From Baseline to 3-months Post-intervention (Within Group)
The Difficulties in Emotion Regulation Scale (DERS) is a brief, 36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation. The measure yields a total score as well as scores on six scales derived through factor analysis. The DERS total score is the mean of the 36 items score, with a potential range of 0-100. High scores indicate worse outcomes.
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the PROMIS v2.0 Ability to Participate in Social Roles and Activities - Short Form 4a T-score From Baseline to 3-months Post-intervention (Within Group)
Change in the PROMIS v2.0 - Ability to Participate in Social Roles and Activities -Short Form 4a (T-score) assesses the perceived ability to perform usual social roles and activities. Four items are worded negatively and are scored on a 5-point scale (5=never to 1= always). Responses are reverse-coded so that higher scores represent fewer limitations (better abilities). PROMIS measure scores are computed to a T-score, where 50 represents the mean for US general population, and 10 is the standard deviation. Within group differences in T-scores (change scores) from baseline to 3-month follow up (3-month follow up T-score minus baseline T-score) were calculated. Positive change scores are indicative of improvement in perceived ability to participate in social roles and activity at the study endpoint.
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the PROMIS v2.0 Emotional Support 4a T-score From Baseline to 3-months Post-intervention (Within Group)
The PROMIS v2.0 - Emotional Support 4a measure contains 4 items that assess perceived feelings of being cared for, valued, and having confidant relationships. Items are scored on a 5-point scale. Scores higher than 50 indicate more emotional support than the population mean. PROMIS measure scores are computed to a T-score, where 50 represents the mean for US general population, and 10 is the standard deviation. Within group differences in T-scores (change scores) from baseline to 3-month follow up were calculated (3-month follow up T-score minus baseline T-score). Positive change scores are indicative of improvement in perceived emotional support at the study endpoint.
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the PROMIS v2.0 Satisfaction With Social Roles and Activities 4a T-score From Baseline to 3-months Post-intervention (Within Group)
The 4-item PROMIS v2.0 - Satisfaction with Social Roles and Activities 4a was administered to participants at baseline and at 3-months post-intervention. The measure assesses satisfaction with performing social roles and activities. Items are scored on a 5-point scale and then reverse coded so that higher scores reflect great abilities to participate. Scores higher than 50 indicate higher perceived satisfaction than the population mean i.e., better outcomes. PROMIS measure scores are computed to a T-score, where 50 represents the mean for US general population, and 10 is the standard deviation. Within group differences in T-scores (change scores) from baseline to 3-month post-intervention were calculated (3-month follow up T-score minus baseline T-score). Positive change scores are indicative of improvement in satisfaction with social roles and activities at the study endpoint.
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the PROMIS v2.0 Social Isolation 4a T-score From Baseline to 3-months Post-intervention (Within Group)
The PROMIS v2.0 - Social Isolation 4a includes 4 items that assess feelings of isolation, companionship, and trust. The items scored on a five-point scale ("never" to "always"). PROMIS measure scores are computed to a T-score, where 50 represents the mean for US general population, and 10 is the standard deviation. Scores higher than 50 indicate more social isolation, i.e. worse outcomes. Within group differences in T-scores (change scores) from baseline to 3-month post-intervention were calculated (3-month follow up T-score minus baseline T-score). Positive change scores are indicative of increased social isolation at the study endpoint; negative change scores indicate decreased social isolation (better outcomes).
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the Pittsburgh Sleep Quality Index Total Score From Baseline to 3-months Post-intervention (Within Group)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report scale consisting of 19 items that produce a global sleep quality score and the following 7 component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. Total score is reported here and has a potential range of 0-21. Higher scores indicate poorer sleep quality.
Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study start1 Jan 2016
- Primary completion26 Feb 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-traumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ursula A Kelly, PhD MSN BA, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640690
- Sponsor's protocol ID
- NRI 15-151
- Acronym
- PSLII
- Status last verified
- Sep 2024
- First submitted
- 16 Dec 2015
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zaccari B, Loftis JM, Haywood T, Hubbard K, Clark J, Kelly UA. Synchronous Telehealth Yoga and Cognitive Processing Group Therapies for Women Veterans with Posttraumatic Stress Disorder: A Multisite Randomized Controlled Trial Adapted for COVID-19. Telemed J E Health. 2022 Mar 29:10.1089/tmj.2021.0612. doi: 10.1089/tmj.2021.0612. Online ahead of print.
PubMed 35357957Kelly U, Haywood T, Segell E, Higgins M. Trauma-Sensitive Yoga for Post-Traumatic Stress Disorder in Women Veterans who Experienced Military Sexual Trauma: Interim Results from a Randomized Controlled Trial. J Altern Complement Med. 2021 Mar;27(S1):S45-S59. doi: 10.1089/acm.2020.0417.
PubMed 33788599Zaccari B, Higgins M, Haywood TN, Patel M, Emerson D, Hubbard K, Loftis JM, Kelly UA. Yoga vs Cognitive Processing Therapy for Military Sexual Trauma-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2344862. doi: 10.1001/jamanetworkopen.2023.44862.
PubMed 38064219O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.
PubMed 37795783
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma
- ClinicalTrials.gov ID
- NCT02640690
- Acronym / sponsor ID
- PSLII / NRI 15-151
- Conditions
- Stress Disorders, Post-traumatic
- Keywords
- Stress Disorders, Post-traumatic, Yoga, Cognitive Therapy, Chronic Pain, Veterans, cytokines, acoustic startle reflex, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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 five 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 were recruited from a primary site (southeast US) and second site (northwest US) and were randomized to Trauma Center Trauma-Sensitive Yoga (TCTSY) (10 weekly sessions) or Cognitive Processing Therapy (CPT) (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, heart rate variability, and dark-enhanced startle. 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma Center Trauma-Sensitive Yoga (TCTSY) | Experimental | Behavioral: Trauma Center Trauma Sensitive Yoga Intervention (TCTSY)10-weekly 1-hour TCTSY Sessions |
| Cognitive Processing Therapy (CPT) | Active comparator | Behavioral: Cognitive Processing Therapy12-weekly 1.5 hour CPT Sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women Veterans who experienced MST
- Diagnosed with PTSD related to MST
- Insomnia
- Willing to participate in either TCTSY or CPT study intervention
Key exclusion criteria (11 listed)
- 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:
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma Center Trauma Sensitive Yoga Intervention (TCTSY)(10) 1-hour sessions of trauma sensitive yoga | Behavioural | Trauma Center Trauma-Sensitive Yoga (TCTSY) |
| Cognitive Processing TherapyAlso: Cognitive Processing Therapy-Cognitive(12) 1.5 hour sessions of cognitive processing therapy | Behavioural | Cognitive Processing Therapy (CPT) |
Primary outcome
Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
Clinician-Administered PTSD Scale for DSM-5 also known as CAPS-5 is the gold standard in PTSD assessment. The CAPS-5 is a structured interview that was used to assess current (past month) PTSD symptom severity. The CAPS-5 total symptom severity score is the sum of 20 items, each scored 0-4, to yield a score with a possible range of 0-80. Higher scores mean worse outcome.
PTSD Symptom Checklist-5 (PCL-5): Change in Mean Total Score From Baseline to 3-month Post-intervention
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
The PTSD Symptom-Checklist -Version 5 (PCL-5) is a 20-item, self-report instrument that assesses the presence and severity of DSM-V PTSD symptoms in the last month. It was summed for a total severity score ranging from 0-80, with higher scores representing greater symptom severity (worse outcomes). Within group changes in mean total PCL-5 score from baseline to 3-month post-intervention are reported here.
14 secondary outcomes
Health-related Quality of Life: VR12, Mental Component Summary (MCS): Change in Mean MCS From Baseline to 3-month Post-intervention
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
Health-related Quality of Life: VR12, Physical Component: Change in Mean Subscale Score From Baseline to 3-month Post-intervention
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
BPI Pain Severity: Change in Total Severity Score From Baseline to 3-months Post-intervention
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
BPI Pain Interference: Change in Total Interference Score From Baseline to 3-months Post-intervention
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).
Changes in C-reactive Proteins (CRP) From Baseline to 3-months Post-intervention; Within Group Changes; Primary Site Only
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in IL-6 Pro-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in IL-10 Anti-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the Beck Depression Inventory-II (BDI-II) Total Score From Baseline to 3-months Post-intervention (Within Group)
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the Difficulties in Emotion Regulation Scale (DERS) Total Score From Baseline to 3-months Post-intervention (Within Group)
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the PROMIS v2.0 Ability to Participate in Social Roles and Activities - Short Form 4a T-score From Baseline to 3-months Post-intervention (Within Group)
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the PROMIS v2.0 Emotional Support 4a T-score From Baseline to 3-months Post-intervention (Within Group)
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the PROMIS v2.0 Satisfaction With Social Roles and Activities 4a T-score From Baseline to 3-months Post-intervention (Within Group)
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the PROMIS v2.0 Social Isolation 4a T-score From Baseline to 3-months Post-intervention (Within Group)
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Changes in the Pittsburgh Sleep Quality Index Total Score From Baseline to 3-months Post-intervention (Within Group)
Time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35357957Zaccari B, Loftis JM, Haywood T, Hubbard K, Clark J, Kelly UA. Synchronous Telehealth Yoga and Cognitive Processing Group Therapies for Women Veterans with Posttraumatic Stress Disorder: A Multisite Randomized Controlled Trial Adapted for COVID-19. Telemed J E Health. 2022 Mar 29:10.1089/tmj.2021.0612. doi: 10.1089/tmj.2021.0612. Online ahead of print.
- Background: PubMed 33788599Kelly U, Haywood T, Segell E, Higgins M. Trauma-Sensitive Yoga for Post-Traumatic Stress Disorder in Women Veterans who Experienced Military Sexual Trauma: Interim Results from a Randomized Controlled Trial. J Altern Complement Med. 2021 Mar;27(S1):S45-S59. doi: 10.1089/acm.2020.0417.
- Results publication: PubMed 38064219Zaccari B, Higgins M, Haywood TN, Patel M, Emerson D, Hubbard K, Loftis JM, Kelly UA. Yoga vs Cognitive Processing Therapy for Military Sexual Trauma-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2344862. doi: 10.1001/jamanetworkopen.2023.44862.
- Derived from this study: PubMed 37795783O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.
- Individual participant dataSharing planned: No
Related trials for Stress Disorders, Post-traumatic
Recruiting
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
Post-Traumatic Stress Disorder
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
RecruitingPhase 3
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
Major Depression
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
RecruitingPhase 2
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
Acute Stress Reaction, Acute Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ursula A Kelly, PhD MSN BA principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Center Trauma Sensitive Yoga Intervention (TCTSY) and Cognitive Processing Therapy in people with Stress Disorders, Post-traumatic, run by VA Office of Research and Development at 2 sites 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 4 inclusion and 11 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 8 Oct 2024). 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?
Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention (time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).). The study lists 2 primary outcomes in all. 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 NCT02640690, which also lists 4 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 8 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.