Yoga and Physical Activity for Veterans

Mechanisms of Change in Yoga and Physical Activity for Veterans

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.

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Hatha yoga; Behavioral: Supportive physical activity

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161-0002
      • VA San Diego Healthcare System, San Diego, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hatha yoga; 12- week group-based yoga class	Behavioral: Hatha yoga; Manualized hatha yoga
Active Comparator: Supportive exercise; 12-week group-based stretching and strengthening class	Behavioral: Supportive physical activity; Manualized stretching and strengthening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 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. Mpre-Mpost is presented, so positive numbers indicate a reduction in PTSD symptom severity from before to after the intervention.	Baseline to post-treatment (approx 12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire Depression Items (PHQ-9)	Self-report measure of depressive symptoms with a range of 0-27. Mpre-Mpost is presented, so positive numbers indicate a reduction in depression severity.	Baseline to post-treatment (approx 12 weeks)
State-Trait Anxiety Inventory, State Subscale	Self-report measure of anxiety symptoms with "state" and "trait" subscales; state is reported. The subscale scores range from 20 to 80. Mpre-Mpost is presented, so positive numbers indicate a reduction in anxiety.	Baseline to post-treatment (approx 12 weeks)
State-Trait Anger Expression Inventory - II (STAXI-II), State Anger Subscale	Self-report measure of anger with three major subscales (state anger, trait anger and anger control index), which are quantified as T-scores (i.e., 50 indicates the population mean with a standard deviation of 10), calculated from published adult norms tables. Change in T-scores, Tpre-Tpost, is presented, so positive numbers indicate a reduction in anger.	Baseline to post-treatment (approx 12 weeks)
Insomnia Severity Index	Self-report measure of insomnia with a range of 0-28. Mpre-Mpost is presented, so positive numbers indicate a reduction in sleep disturbance.	Baseline to post-treatment (approx 12 weeks)
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a	Self-report measure of pain interference, reported as a T-score (i.e., 50 indicates the population mean with a standard deviation of 10) calculated from published adult norms table. Change in T-scores, Tpre-Tpost, is presented, so positive numbers indicate a reduction in pain interference.	Baseline to post-treatment (approx 12 weeks)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Ariel J. Lang, PhD, VA San Diego Healthcare System, San Diego, CA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; exercise; yoga
• Other Study ID Numbers: MHBB-007-17F; CX001647-01A1 (Other Grant/Funding Number: VA CSR&D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Specific parameters of sharing are not yet established

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No