Clinical trial NCT03509909: Yoga and Physical Activity for Veterans
Official title: Mechanisms of Change in Yoga and Physical Activity for Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: yoga
exercise
randomized controlled trial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-04-26
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental condition: Manualized hatha yoga, a 12-session group-based yoga class led by a trained teacher Control condition: Manualized supportive physical activity, a 12-session group-based stretching and strengthening class led by a trained instructor
Primary purpose: TREATMENT

Brief 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.

Detailed description: Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition with a broad negative impact on physical and mental health functioning. Excellent, empirically-supported interventions for PTSD are readily available to Veterans, but the majority of patients who receive the best available treatments continue to have a diagnosable disorder after treatment. This suggests that complementary interventions may be useful to fully restore functioning. In addition, many patients seek alternatives to psychotherapy or pharmacotherapy. This is evident in the increasing numbers of individuals with PTSD are turning to alternative approaches. At present, however, the investigators lack a good evidence base from which to make recommendations about the use of complementary and alternative approaches.

Yoga is very popular practice, touted to enhance physical, mental and spiritual well-being. Many Veterans with PTSD have turned to yoga as a part of their recovery plan, often seeking care outside the specialty mental health system. Initial evidence suggests that the practice leads to clinically significant change in symptoms, but results are yet inconclusive, particularly in Veterans. Thus, this project will provide additional data as to efficacy of yoga for Veterans PTSD.

The study is a randomized controlled trial involving approximately 100 Veterans with PTSD from the San Diego area. These Veterans will be randomized to receive a manualized hatha yoga intervention or a supportive exercise control condition. Both interventions will be delivered by trained instructors via livestreaming or recorded classes over a 12-week period. Assessment of clinical outcomes and methodological variables will take place before, during, immediately after, and 3-months after the intervention. Analyses will focus on change in the intervention groups over time and the degree to which change is associated with the candidate mechanisms.

Results of this study have the potential to inform the way in which yoga is delivered to Veterans as well as to increase knowledge about the underlying processes by which PTSD can be ameliorated. Given the high demand for yoga demand by individuals with PTSD and the degree to which the practice is already being provided in many clinical settings, findings from this study will be immediately relevant. Findings may also guide future research in complementary and alternative approaches by demonstrating the principle of targeting different processes of change to create an integrative care plan.

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

Primary outcomes:
measure: Clinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5)
timeFrame: Baseline to post-treatment (approx 12 weeks)
Secondary outcomes:
measure: Patient Health Questionnaire Depression Items (PHQ-9)
timeFrame: Baseline to post-treatment (approx 12 weeks)
measure: State-Trait Anxiety Inventory, State Subscale
timeFrame: Baseline to post-treatment (approx 12 weeks)
measure: State-Trait Anger Expression Inventory - II (STAXI-II), State Anger Subscale
timeFrame: Baseline to post-treatment (approx 12 weeks)
measure: Insomnia Severity Index
timeFrame: Baseline to post-treatment (approx 12 weeks)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a
timeFrame: Baseline to post-treatment (approx 12 weeks)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Ariel J. Lang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lang AJ, Malaktaris A, Maluf KS, Kangas J, Sindel S, Herbert M, Bomyea J, Simmons AN, Weaver J, Velez D, Liu L. A randomized controlled trial of yoga vs nonaerobic exercise for veterans with PTSD: Understanding efficacy, mechanisms of change, and mode of delivery. Contemp Clin Trials Commun. 2021 Jan 28;21:100719. doi: 10.1016/j.conctc.2021.100719. eCollection 2021 Mar.