Yoga and Physical Activity for Veterans

PTSD Clinical Trial

Official title:

Mechanisms of Change in Yoga and Physical Activity for Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509909
• Other study ID #: MHBB-007-17F
• Secondary ID: CX001647-01A1
• Status: Completed
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Hatha yoga
Manualized hatha yoga
• Supportive physical activity
Manualized stretching and strengthening

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	Semi-structured clinical interview assessing severity of PTSD symptoms administered by a trained, blinded assessor. The range of scores is 0-80 with higher scores indicating more severe PTSD.	Change from baseline to post-treatment (approx 12 weeks)
Secondary	Patient Health Questionnaire depression items (PHQ-9)	Self-report measure of depressive symptoms with a range of 0-27 with higher scores indicating more severe depressive symptoms.	Change from baseline to post-treatment (approx 12 weeks)
Secondary	State-Trait Anxiety Inventory	Self-report measure of anxiety symptoms with "state" and "trait" subscales. The subscale scores range from 20 to 80 with higher scores indicating more anxiety.	Change from baseline to post-treatment (approx 12 weeks)
Secondary	State-Trait Anger Expression Inventory - II	Self-report measure of anger with three major subscales (state anger, trait anger and anger control index), which are reported as T-scores.	Change from baseline to post-treatment (approx 12 weeks)
Secondary	Insomnia Severity Index	Self-report measure of insomnia with a range of 0-28 with higher scores indicating more severe sleep problems	Change from baseline to post-treatment (approx 12 weeks)
Secondary	PROMIS Pain Intensity 3a and Pain Interference 4a	Self-report measure of pain intensity and interference, both reported as T-scores	Change from baseline to post-treatment (approx 12 weeks)