Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CX001647-01A1 | Other Grant/Funding Number | VA CSR&D |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hatha yoga | Experimental | 12- week group-based yoga class |
|
| Supportive exercise | Active Comparator | 12-week group-based stretching and strengthening class |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hatha yoga | Behavioral | Manualized hatha yoga |
| |
| Supportive physical activity |
| 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) |
| 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 |
Not provided
Inclusion Criteria:
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
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ariel J. Lang, PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161-0002 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33604485 | Background | 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. |
Not provided
Not provided
Specific parameters of sharing are not yet established
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Hatha Yoga | 12- week group-based yoga class Hatha yoga: Manualized hatha yoga |
| FG001 | Supportive Exercise | 12-week group-based stretching and strengthening class Supportive physical activity: Manualized stretching and strengthening |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hatha Yoga | 12- week group-based yoga class Hatha yoga: Manualized hatha yoga |
| BG001 | Supportive Exercise | 12-week group-based stretching and strengthening class Supportive physical activity: Manualized stretching and strengthening |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score. | Posted | Mean | Standard Deviation | change in units on a scale | Baseline to post-treatment (approx 12 weeks) |
|
24 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hatha Yoga | 12- week group-based yoga class Hatha yoga: Manualized hatha yoga |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Broken bones | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Acute injury secondary to a car accident |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal issues | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ariel J Lang | VA San Diego Healthcare System | 858-552-8585 | 5359 | ariel.lang@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2022 | Nov 8, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
Not provided
Not provided
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
Not provided
Not provided
The outcome evaluator is blind to experimental condition
| Behavioral |
Manualized stretching and strengthening |
|
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) |
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Martial status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
12-week group-based stretching and strengthening class Supportive physical activity: Manualized stretching and strengthening |
|
|
|
| Secondary | 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. | Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score. | Posted | Mean | Standard Deviation | change in units on a scale | Baseline to post-treatment (approx 12 weeks) |
|
|
|
| Secondary | 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. | Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score. | Posted | Mean | Standard Deviation | change in units on a scale | Baseline to post-treatment (approx 12 weeks) |
|
|
|
| Secondary | 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. | Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score. | Posted | Mean | Standard Deviation | change in T-score | Baseline to post-treatment (approx 12 weeks) |
|
|
|
| Secondary | 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. | Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score. | Posted | Mean | Standard Deviation | change in units on a scale | Baseline to post-treatment (approx 12 weeks) |
|
|
|
| Secondary | 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. | Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score. Loss of data increased as scale is invalid if all items are not answered. | Posted | Mean | Standard Deviation | change in T-score | Baseline to post-treatment (approx 12 weeks) |
|
|
|
| 0 |
| 67 |
| 2 |
| 67 |
| 25 |
| 67 |
| EG001 | Supportive Exercise | 12-week group-based stretching and strengthening class Supportive physical activity: Manualized stretching and strengthening | 0 | 50 | 1 | 50 | 29 | 50 |
|
| Alcohol withdrawal | Psychiatric disorders | Systematic Assessment |
|
| Overdose | Psychiatric disorders | Systematic Assessment |
|
| Muscle/tissue soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Emotional distress | Psychiatric disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Symptoms of illness, including cold, flu and COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided