N/A N=131 Randomized Treatment

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

Stress Disorders, Post-traumatic

Bottom Line

View on ClinicalTrials.gov: NCT02640690 ↗

Enrolled (actual)

131

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention — -11.41; -14.48 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Trauma Center Trauma Sensitive Yoga Intervention (TCTSY) (Behavioral); Cognitive Processing Therapy (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: VA Office of Research and Development
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention	-11.41; -14.48	—
PRIMARY PTSD Symptom Checklist-5 (PCL-5): Change in Mean Total Score From Baseline to 3-month Post-intervention	-9.99; -13.22	—
SECONDARY Health-related Quality of Life: VR12, Mental Component Summary (MCS): Change in Mean MCS From Baseline to 3-month Post-intervention	4.92; 7.14	—
SECONDARY Health-related Quality of Life: VR12, Physical Component: Change in Mean Subscale Score From Baseline to 3-month Post-intervention	-2.74; -2.04	—
SECONDARY BPI Pain Severity: Change in Total Severity Score From Baseline to 3-months Post-intervention	0.17; 0.30	—
SECONDARY BPI Pain Interference: Change in Total Interference Score From Baseline to 3-months Post-intervention	0.09; 0.12	—
SECONDARY Changes in C-reactive Proteins (CRP) From Baseline to 3-months Post-intervention; Within Group Changes; Primary Site Only	-0.02; 0.17	—
SECONDARY Changes in IL-6 Pro-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only	-0.30; 0.01	—
SECONDARY Changes in IL-10 Anti-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only	0.42; 0.18	—
SECONDARY Changes in the Beck Depression Inventory-II (BDI-II) Total Score From Baseline to 3-months Post-intervention (Within Group)	-6.89; -9.70	—
SECONDARY Changes in the Difficulties in Emotion Regulation Scale (DERS) Total Score From Baseline to 3-months Post-intervention (Within Group)	-6.64; -15.68	—
SECONDARY 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)	1.62; 3.29	—
SECONDARY Changes in the PROMIS v2.0 Emotional Support 4a T-score From Baseline to 3-months Post-intervention (Within Group)	0.60; 2.78	—
SECONDARY Changes in the PROMIS v2.0 Satisfaction With Social Roles and Activities 4a T-score From Baseline to 3-months Post-intervention (Within Group)	1.92; 2.55	—
SECONDARY Changes in the PROMIS v2.0 Social Isolation 4a T-score From Baseline to 3-months Post-intervention (Within Group)	-1.26; -2.65	—
SECONDARY Changes in the Pittsburgh Sleep Quality Index Total Score From Baseline to 3-months Post-intervention (Within Group)	-0.57; -2.32	—

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.

Eligibility Criteria

Inclusion Criteria

Women Veterans who experienced MST
Diagnosed with PTSD related to MST
Insomnia
Willing to participate in either TCTSY or CPT 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02640690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.