N/A
N=117
Yoga and Physical Activity for Veterans
PTSD
Bottom Line
View on ClinicalTrials.gov: NCT03509909 ↗Enrolled (actual)
117
Serious AEs
2.6%
Results posted
Nov 2024
Primary outcome: Primary: Clinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5) — 3.92; 3.46 change in units on a scale — p=0.74
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hatha yoga (Behavioral); Supportive physical activity (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5) |
3.92; 3.46 | 0.74 |
| SECONDARY Patient Health Questionnaire Depression Items (PHQ-9) |
3.79; 2.11 | — |
| SECONDARY State-Trait Anxiety Inventory, State Subscale |
0.23; -0.53 | — |
| SECONDARY State-Trait Anger Expression Inventory - II (STAXI-II), State Anger Subscale |
1.02; 1.08 | — |
| SECONDARY Insomnia Severity Index |
2.73; 1.64 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a |
0.8; 0.92 | — |
Summary
Posttraumatic stress disorder (PTSD) is a major health problem for the nation's Veterans, leading to significant physical and mental health morbidity and mortality. Current empirically-supported interventions ameliorate symptoms but generally do not restore full functioning, so the development of alternative or complementary approaches is a critical need. Large numbers of Veterans are seeking out yoga as a part of their recovery plans, but there is not enough evidence to recommend yoga for treatment of PTSD. Likely reflecting this heterogeneity, evidence of yoga's efficacy is highly variable. This project aims to address this problem by comparing the effect of yoga to a matched exercise control condition. The study will also explore the mechanisms by which yoga impacts PTSD. Ultimately, the goal of this research would be to contribute to integrative care planning, whereby multiple approaches can be applied in a synergistic manner to restore wellness for Veterans affected by PTSD.
Eligibility Criteria
Inclusion Criteria
- Veterans who have clinically meaningful PTSD symptoms
Exclusion Criteria
- serious suicidality or homicidality that has required urgent or emergent evaluation or treatment within the past three months
- a known, untreated substance abuse or dependence problem
- inclusion is possible if there is evidence that the individual has been afforded and is complying with treatment for the substance problem
- serious mental disorders, such as psychotic disorders or bipolar type I, or serious dissociative symptoms
- cognitive impairment that would interfere with treatment
- circumstances that lead to recurrent traumatization
- e.g., engaged in a violent relationship
- any medical condition for which exercise is contraindicated, including pregnancy
- concurrent enrollment in any other treatment specifically targeting PTSD symptoms or in any meditative or mind-body intervention
- including yoga practice >1 class/month in the preceding 6 months
Data sourced from ClinicalTrials.gov (NCT03509909). 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.