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Yoga and Physical Activity for Veterans

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ClinicalTrials.gov Identifier: NCT03509909
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE April 17, 2018
First Posted Date  ICMJE April 26, 2018
Last Update Posted Date March 18, 2021
Actual Study Start Date  ICMJE May 16, 2019
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Change from baseline to post-treatment (approx 12 weeks) ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
  • Patient Health Questionnaire depression items (PHQ-9) [ Time Frame: Change from baseline to post-treatment (approx 12 weeks) ]
    Self-report measure of depressive symptoms with a range of 0-27 with higher scores indicating more severe depressive symptoms.
  • State-Trait Anxiety Inventory [ Time Frame: Change from baseline to post-treatment (approx 12 weeks) ]
    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.
  • State-Trait Anger Expression Inventory - II [ Time Frame: Change from baseline to post-treatment (approx 12 weeks) ]
    Self-report measure of anger with three major subscales (state anger, trait anger and anger control index), which are reported as T-scores.
  • Insomnia Severity Index [ Time Frame: Change from baseline to post-treatment (approx 12 weeks) ]
    Self-report measure of insomnia with a range of 0-28 with higher scores indicating more severe sleep problems
  • PROMIS Pain Intensity 3a and Pain Interference 4a [ Time Frame: Change from baseline to post-treatment (approx 12 weeks) ]
    Self-report measure of pain intensity and interference, both reported as T-scores
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yoga and Physical Activity for Veterans
Official Title  ICMJE Mechanisms of Change in Yoga and Physical Activity for Veterans
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 no standardization of yoga protocols. Likely reflecting this heterogeneity, evidence of yoga's efficacy is highly variable. This project aims to address this problem by elucidating the mechanisms by which yoga impacts PTSD, thereby guiding the development of standards for yoga for 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.

One reason that the yoga literature is yet inconclusive may be the tremendous heterogeneity in the way in which the yoga is implemented. By understanding the mechanisms by which yoga affects PTSD symptoms, universal change processes can be identified. This project, therefore, will examine a set of candidate processes, which are known important determinants of PTSD symptomatology and potentially modifiable by yoga practice, in order to understand which are contributing to symptom change. With 30 million Americans practicing yoga, dissemination of a specific protocol would not be practicable. Nonetheless, guidelines for trauma-sensitive yoga, which focus primarily on acceptability of the practice for traumatized individuals, appear to be associated with better outcomes for those with PTSD. This work would facilitate the extension of such guidelines to include practice features that maximize the impact of yoga on PTSD symptoms.

The proposed study is a randomized controlled trial involving 192 Veterans with PTSD from the San Diego area. These Veterans will be randomized to receive a manualized hatha yoga intervention or a supportive physical activity control condition. Both interventions will be delivered by trained instructors in a group setting 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Outcomes Assessor)
Masking Description:
The outcome evaluator is blind to experimental condition
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE
  • Behavioral: Hatha yoga
    Manualized hatha yoga
  • Behavioral: Supportive physical activity
    Manualized stretching and strengthening
Study Arms  ICMJE
  • Experimental: Hatha yoga
    12- week group-based yoga class
    Intervention: Behavioral: Hatha yoga
  • Active Comparator: Supportive physical activity
    12-week group-based stretching and strengthening class
    Intervention: Behavioral: Supportive physical activity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2018)
192
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ariel J Lang, PhD (619) 400-5173 Ariel.Lang@va.gov
Contact: Selin Sindel (858) 825-6004 selin.sindel@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03509909
Other Study ID Numbers  ICMJE MHBB-007-17F
CX001647-01A1 ( Other Grant/Funding Number: VA CSR&D )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Specific parameters of sharing are not yet established
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ariel J. Lang, PhD VA San Diego Healthcare System, San Diego, CA
PRS Account VA Office of Research and Development
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP