NCT02640690: PSLII

Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma

Completed NA Results posted Last updated 8 October 2024

What this trial tests

NA trial testing Trauma Center Trauma Sensitive Yoga Intervention (TCTSY) in Stress Disorders, Post-traumatic in 131 participants. Completed in 30 September 2021.

Timeline

1 January 2016

Primary endpoint
26 February 2021

30 September 2021

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	131
Start date	1 January 2016
Primary completion	26 February 2021
Estimated completion	30 September 2021
Sites	2 locations across United States

Drugs / interventions tested

• Trauma Center Trauma Sensitive Yoga Intervention (TCTSY)
• Cognitive Processing Therapy

Conditions studied

• Stress Disorders, Post-traumatic — all drugs for Stress Disorders, Post-traumatic →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, female only, with Stress Disorders, Post-traumatic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention Primary · 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.

Group	Value	95% CI
Trauma Center Trauma-Sensitive Yoga (TCTSY)	-11.41	± 12.32
Cognitive Processing Therapy (CPT)	-14.48	± 12.01

PTSD Symptom Checklist-5 (PCL-5): Change in Mean Total Score From Baseline to 3-month Post-intervention Primary · 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.

Group	Value	95% CI
Trauma Center Trauma-Sensitive Yoga (TCTSY)	-9.99	± 18.6
Cognitive Processing Therapy (CPT)	-13.22	± 17.39

Health-related Quality of Life: VR12, Mental Component Summary (MCS): Change in Mean MCS From Baseline to 3-month Post-intervention Secondary · 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 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

Group	Value	95% CI
Trauma Center Trauma-Sensitive Yoga (TCTSY)	4.92	± 13.26
Cognitive Processing Therapy (CPT)	7.14	± 9.15

Health-related Quality of Life: VR12, Physical Component: Change in Mean Subscale Score From Baseline to 3-month Post-intervention Secondary · 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 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

Group	Value	95% CI
Trauma Center Trauma-Sensitive Yoga (TCTSY)	-2.74	± 8.34
Cognitive Processing Therapy (CPT)	-2.04	± 9.68

BPI Pain Severity: Change in Total Severity Score From Baseline to 3-months Post-intervention Secondary · 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 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.

Group	Value	95% CI
Trauma Center Trauma-Sensitive Yoga (TCTSY)	0.17	± 1.66
Cognitive Processing Therapy (CPT)	0.30	± 1.42

BPI Pain Interference: Change in Total Interference Score From Baseline to 3-months Post-intervention Secondary · 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 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.

Group	Value	95% CI
Trauma Center Trauma-Sensitive Yoga (TCTSY)	0.09	± 2.41
Cognitive Processing Therapy (CPT)	0.12	± 2.07

Changes in C-reactive Proteins (CRP) From Baseline to 3-months Post-intervention; Within Group Changes; Primary Site Only Secondary · 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.

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).

Group	Value	95% CI
Trauma Center Trauma-Sensitive Yoga (TCTSY)	-0.02	± 0.76
Cognitive Processing Therapy (CPT)	0.17	± 0.58

Changes in IL-6 Pro-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only Secondary · 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.

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).

Group	Value	95% CI
Trauma Center Trauma-Sensitive Yoga (TCTSY)	-0.30	± 1.23
Cognitive Processing Therapy (CPT)	0.01	± 1.12

Changes in IL-10 Anti-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only Secondary · 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.

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.

Group	Value	95% CI
Trauma Center Trauma-Sensitive Yoga (TCTSY)	0.42	± 1.75
Cognitive Processing Therapy (CPT)	0.18	± 1.18

Changes in the Beck Depression Inventory-II (BDI-II) Total Score From Baseline to 3-months Post-intervention (Within Group) Secondary · 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.

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.

Group	Value	95% CI
Trauma Center Trauma-Sensitive Yoga (TCTSY)	-6.89	± 9.68
Cognitive Processing Therapy (CPT)	-9.70	± 10.37

Changes in the Difficulties in Emotion Regulation Scale (DERS) Total Score From Baseline to 3-months Post-intervention (Within Group) Secondary · 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.

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.

Group	Value	95% CI
Trauma Center Trauma-Sensitive Yoga (TCTSY)	-6.64	± 24.95
Cognitive Processing Therapy (CPT)	-15.68	± 18.91

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) Secondary · 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.

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

Group	Value	95% CI
Trauma Center Trauma-Sensitive Yoga (TCTSY)	1.62	± 6.92
Cognitive Processing Therapy (CPT)	3.29	± 6.67

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trauma-Sensitive Yoga for Post-Traumatic Stress Disorder in Women Veterans who Experienced Military Sexual Trauma: Interim Results from a Randomized Controlled Trial.
   Kelly U, Haywood T, Segell E, Higgins M. · · 2021 · cited 27× · PMID 33788599 · DOI 10.1089/acm.2020.0417
2. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood.
   O'Doherty L, Whelan M, Carter GJ, Brown K, et al · · 2023 · cited 21× · PMID 37795783 · DOI 10.1002/14651858.cd013456.pub2
3. Synchronous Telehealth Yoga and Cognitive Processing Group Therapies for Women Veterans with Posttraumatic Stress Disorder: A Multisite Randomized Controlled Trial Adapted for COVID-19.
   Zaccari B, Loftis JM, Haywood T, Hubbard K, et al · · 2022 · cited 14× · PMID 35357957 · DOI 10.1089/tmj.2021.0612
4. Yoga vs Cognitive Processing Therapy for Military Sexual Trauma-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial.
   Zaccari B, Higgins M, Haywood TN, Patel M, et al · · 2023 · cited 13× · PMID 38064219 · DOI 10.1001/jamanetworkopen.2023.44862
5. Trauma Center Trauma-Sensitive Yoga Versus Cognitive Processing Therapy for Women Veterans With PTSD Who Experienced Military Sexual Trauma: A Feasibility Study.
   Zaccari B, Sherman ADF, Higgins M, Ann Kelly U. · · 2024 · cited 5× · PMID 35833676 · DOI 10.1177/10783903221108765
6. Effects of group trauma-sensitive yoga on inflammatory markers and psychological well-being in women veterans with PTSD: A randomized controlled trial.
   Zaccari B, Kelly UA, Lovejoy TI, Hubbard K, et al · · 2023 · PMID 41836366 · DOI 10.1016/j.bbii.2023.100031