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 : October 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Behavioral: Hatha yoga Behavioral: Supportive physical activity||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||192 participants|
|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|
|Official Title:||Mechanisms of Change in Yoga and Physical Activity for Veterans|
|Actual Study Start Date :||May 16, 2019|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Hatha yoga
12- week group-based yoga class
Behavioral: Hatha yoga
Manualized hatha yoga
Active Comparator: Supportive physical activity
12-week group-based stretching and strengthening class
Behavioral: Supportive physical activity
Manualized stretching and strengthening
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509909
|Contact: Ariel J Lang, PhD||(619) 400-5173||Ariel.Lang@va.gov|
|Contact: Deborah J Velez, NP||(858) 552-8585 ext email@example.com|
|United States, California|
|VA San Diego Healthcare System, San Diego, CA||Recruiting|
|San Diego, California, United States, 92161|
|Contact: Ariel J Lang, PhD 619-400-5173 Ariel.Lang@va.gov|
|Principal Investigator: Ariel J. Lang, PhD|
|Principal Investigator:||Ariel J. Lang, PhD||VA San Diego Healthcare System, San Diego, CA|