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

NCT02640690 | Completed Results DMC

• 1 other identifier: NRI 15-151
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

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.

Conditions

Stress Disorders, Post-traumatic

Keywords

Stress Disorders, Post-traumatic; Yoga; Cognitive Therapy; Chronic Pain; Veterans; cytokines; acoustic startle reflex; women; heart rate variability; sexual trauma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  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.

Study Arms (2)

Trauma Center Trauma-Sensitive Yoga (TCTSY)

EXPERIMENTAL

10-weekly 1-hour TCTSY Sessions

Behavioral: Trauma Center Trauma Sensitive Yoga Intervention (TCTSY)

Cognitive Processing Therapy (CPT)

ACTIVE COMPARATOR

12-weekly 1.5 hour CPT Sessions

Behavioral: Cognitive Processing Therapy

Interventions

Trauma Center Trauma Sensitive Yoga Intervention (TCTSY) BEHAVIORAL

(10) 1-hour sessions of trauma sensitive yoga

Trauma Center Trauma-Sensitive Yoga (TCTSY)

Cognitive Processing Therapy BEHAVIORAL

(12) 1.5 hour sessions of cognitive processing therapy

Also known as: Cognitive Processing Therapy-Cognitive

Cognitive Processing Therapy (CPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related Publications (4)

• 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.

  PMID: 35357957 BACKGROUND

• Kelly 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.

  PMID: 33788599 BACKGROUND

• Zaccari 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.

  PMID: 38064219 RESULT

• O'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.

  PMID: 37795783 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Chronic Pain; Sexual Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study end point of three months post-treatment precluded determination of even longer-term sustained effects of the interventions. The CAPS-5 assessors were not blinded, introducing a risk of bias. The final cohort at Site 1 and the only cohort at Site 2 were conducted in 2020 during the COVID-19 pandemic, resulting in a pivot of study procedures to virtual delivery - which potentially confounded study data during that time.

Results Point of Contact

• Title: Dr. Ursula Kelly
• Organization: Atlanta VA Health Care System

ukelly@emory.edu

4047272715

Study Officials

• Ursula A Kelly, PhD MSN BA

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 29, 2015
• Study Start: January 1, 2016
• Primary Completion: February 26, 2021
• Study Completion: September 30, 2021
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)