PTSDNCT03509909
Yoga and Physical Activity for Veterans
A study testing Hatha yoga and Supportive physical activity in people with PTSD, run by VA Office of Research and Development at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Hatha yoga and Supportive physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans who have clinically meaningful PTSD symptoms
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
About this study
Official title: 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.
Read the 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.
- Conditions
- PTSD
- Being tested
- Hatha yoga, Supportive physical activity
- Keywords
- yoga, exercise, randomized controlled trial
- Medical subject headings
- Stress Disorders, Post-Traumatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hatha yogaBehavioural
Manualized hatha yoga
Supportive physical activityBehavioural
Manualized stretching and strengthening
| Study group | Role | What they receive |
|---|---|---|
| Hatha yoga | Experimental | 12- week group-based yoga class Receives: Behavioral: Hatha yoga |
| Supportive exercise | Active comparator | 12-week group-based stretching and strengthening class Receives: Behavioral: Supportive physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to post-treatment (approx 12 weeks)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to post-treatment (approx 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start16 May 2019
- Primary completion30 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ariel J. Lang, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509909
- Sponsor's protocol ID
- MHBB-007-17F
- Other IDs
- CX001647-01A1
- Status last verified
- Nov 2024
- First submitted
- 17 Apr 2018
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Specific parameters of sharing are not yet established
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.
PubMed 33604485
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Change in Yoga and Physical Activity for Veterans
- ClinicalTrials.gov ID
- NCT03509909
- Acronym / sponsor ID
- MHBB-007-17F
- Conditions
- PTSD
- Keywords
- yoga, exercise, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 16 May 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Hatha yoga | Experimental | Behavioral: Hatha yoga12- week group-based yoga class |
| Supportive exercise | Active comparator | Behavioral: Supportive physical activity12-week group-based stretching and strengthening class |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans who have clinically meaningful PTSD symptoms
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hatha yogaManualized hatha yoga | Behavioural | Hatha yoga |
| Supportive physical activityManualized stretching and strengthening | Behavioural | Supportive exercise |
Primary outcome
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5)
Time frame: 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. Mpre-Mpost is presented, so positive numbers indicate a reduction in PTSD symptom severity from before to after the intervention.
5 secondary outcomes
Patient Health Questionnaire Depression Items (PHQ-9)
Time frame: Baseline to post-treatment (approx 12 weeks)
State-Trait Anxiety Inventory, State Subscale
Time frame: Baseline to post-treatment (approx 12 weeks)
State-Trait Anger Expression Inventory - II (STAXI-II), State Anger Subscale
Time frame: Baseline to post-treatment (approx 12 weeks)
Insomnia Severity Index
Time frame: Baseline to post-treatment (approx 12 weeks)
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a
Time frame: Baseline to post-treatment (approx 12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33604485Lang 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.
- Individual participant dataSharing planned: No. Specific parameters of sharing are not yet established
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel J. Lang, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha yoga and Supportive physical activity in people with PTSD, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5) (time frame: Baseline to post-treatment (approx 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03509909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.