Stress Disorders, Post-TraumaticRELIEVENCT02234622

Comparing Effects of a Holistic Yoga Program and a Wellness Program on PTSD Symptoms

A study testing Holistic Yoga Program and Wellness Lifestyle Program in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Given the limited effectiveness of current treatments and the burden PTSD places on Veterans, civilians and clinicians, this research aims to compare the effects of a standardized, traditional, holistic yoga intervention (postures, breathing, deep muscle contraction and relaxation practices) with a wellness program… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stress Disorders, Post-Traumatic
What is being tested?: Holistic Yoga Program and Wellness Lifestyle Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 212 participants
Where: 1 siteUnited States
Study dates: 3 Aug 2015to 9 Aug 2018
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 and civilians will be eligible for inclusion if
they are age 18 or older,
have a Clinician Administered PTSD Scale-confirmed PTSD diagnosis,
and access to a working telephone for ease of contact during the course of the study.

Who cannot join

severe medical conditions in which yoga is contraindicated;
active psychosis;
active suicidal intent;
moderate to severe cognitive impairment as determined by the short Mini-Mental State Examination, a six-item screener (MMSE);
involvement in ongoing yoga classes and/or regular home practice of yoga in the previous 3 months;
and receiving ongoing medical or psychological treatment that includes more than one hour weekly of relaxation and mind-body based stress reduction strategies (related directly to meditation and yoga).

Trial locations and contacts

1 site in 1 country.

United States1 site

Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884

Other trials in United States

About this study

Official title: Outcomes of a Holistic Yoga Program Designed to Relieve PTSD (RELIEVE Trial)

Read the detailed description

Posttraumatic Stress Disorder constitutes a substantial proportion of the burden of illness among Veterans. However, current PTSD treatments are not effective for all, and a significant number remain symptomatic despite pharmacotherapy and psychotherapy. As a result, there has been increased interest within the military and VA in Complementary and Alternative Medicine approaches, such as yoga, to improve symptoms without requiring direct verbal processing of the trauma. Yoga provides an innovative approach to calming hyperarousal, reducing numbness/avoidance, and improving self-regulation of emotions, while cultivating physical and emotional well-being. Because of this unique approach to the biological, psychological, and social dimensions of PTSD, we believe that yoga interventions are poised to meet the demand for more effective PTSD treatment options for Veterans. Recent research indicates that yoga interventions can be delivered successfully to individuals who have PTSD and have the potential to reduce clinician rated and self-reported overall PTSD symptoms, depression and anxiety. However, few studies exist that have evaluated yoga for PTSD and they have involved small sample sizes and are either uncontrolled or waitlist/usual care controlled. Also, there is much variation among studies in the style and components of yoga interventions. Thus, a randomized controlled trial of a standardized, traditional, holistic yoga intervention is urgently needed to inform VA policy makers and clinicians of the potential benefits of yoga as an adjunct to currently available PTSD treatments.

OBJECTIVE: The overall goal of this project is to compare the effects of a 16-week Holistic Yoga Program (HYP) with a 16-week Wellness Lifestyle Program (WLP) on PTSD and related symptoms and outcomes. This project has three specific aims: 1) to compare the effects of the interventions (HYP vs. WLP) on overall PTSD symptom severity; 2) compare the interventions' effects on PTSD-specific symptoms (anger, sleep), PTSD-related symptoms (depression, anxiety, pain) and related outcomes (well-being/quality of life); 3) to manualize the Holistic Yoga Program and training process for experienced yoga teachers to deliver HYP to individuals who have PTSD in order to facilitate future study and dissemination efforts.

METHODS: This study sample will include 212 outpatients with a clinician-confirmed diagnosis of PTSD, recruited from the Roudebush VA Medical Center as well as metropolitan area mental health clinicians and military/Veterans' organizations, who will be randomly assigned to receive the Holistic Yoga Program (HYP) or the Wellness Lifestyle Program (WLP). The HYP will involve a standardized 16-week intervention consisting of: 1) in-person group yoga class taught by a yoga therapist (Yoga Alliance minimum 200 hour level) with trained assistants.Classes will include (1) yoga postures, breathing practices, deep muscle contraction practices, relaxation practices, and integration of scientific rational and yoga philosophy within the instruction; (2) video and audio recordings for home practice; and 4) a Participant Handbook to reinforce concepts taught during in-person sessions. The WLP is an attention control comprised of low intensity walking and didactics about wellness topics that will also encourage home practice and provide a Participant Handbook to reinforce concepts taught during in-person sessions.

Conditions: Stress Disorders, Post-Traumatic
Being tested: Holistic Yoga Program, Wellness Lifestyle Program
Keywords: Stress Disorders, Post-Traumatic, Yoga, Veterans
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Holistic Yoga ProgramBehavioural
Also called HYP
The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
Wellness Lifestyle ProgramBehavioural
Also called WLP
The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.

Study groups in NCT02234622
Study group	Role	What they receive
Holistic Yoga Program	Experimental	The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention. Receives: Behavioral: Holistic Yoga Program
Wellness Lifestyle Program	Active comparator	The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics. Receives: Behavioral: Wellness Lifestyle Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinician Administered PTSD Scale (CAPS-5)
The CAPS is a semi-structured clinician administered interview that measures PTSD diagnostic status and symptom severity consistent with the Diagnostic and Statistical Manual-Fifth Edition. Scores range 0-80 with higher scores meaning a worse outcome.
Measured: Change from baseline to 16 weeks (end of treatment)
PTSD Checklist
PTSD self-reported symptom severity will be assessed with the PTSD Checklist-5 (PCL-5), a 20-item self-report measure of the 5th version of the Diagnostic and Statistics Manual (DSM-5) symptoms of PTSD used as a measure of change in PTSD symptoms as a function of treatment. Scores range 0-80 with higher scores indicating worse outcome.
Measured: Change from baseline to 16 weeks (end of treatment)

Secondary outcomes (5)

Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II
Medical Outcomes Study Sleep Scale (MOS) Problem Index II is a 9-item sub-scale of the 12-item MOS self-report measure that assesses sleep quality (sleep disturbance, adequacy of sleep, and sleep quantity). The item scores of the 9-item sub-scale range from 1-6 and the sub-scale totals are converted to scores ranging 0-100, with higher scores indicating a worse outcome.
Measured: Change from baseline to 16 weeks (end of treatment)
Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a
PROMIS - short form 5a is a 5-item self-report measure to assess feelings of anger over the past 7 days. Total scores, ranging 5-25 are converted to T-scores with higher scores indicating poorer outcome. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. T-scores range from 0-100
Measured: Change from baseline to 16 weeks (end of treatment)
Beck Depression Inventory-II
Depression will be measured by the Beck Depression Inventory (BDI), a 21-item self-report measure, the total score of which ranges 0-63 with higher scores indicating a poorer outcome.
Measured: Change from baseline to 16 weeks (end of treatment)
Spielberger State-Trait Anxiety (STAI) - State Subscale
Anxiety will be measured by the Spielberger State-Trait Anxiety Inventory (STAI), State Anxiety subscale, a self-report instrument consisting of 20-items rated on a 4-point scale (1-4), with a possible range of 20-80. Higher scores indicate worse outcome.
Measured: Change from baseline to 16 weeks (end of treatment)
Brief Pain Inventory (BPI) Item #3
Pain will be assessed using the Brief Pain Inventory (BPI), item #3 which is an indicator of average pain severity in the past week. Scores range from 0-10 with higher scores indicating poorer outcome.
Measured: Change from baseline to 16 weeks (end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Aug 20159 Aug 2018

First posted9 Sep 2014 (estimated)
Study start3 Aug 2015
Primary completion9 Aug 2018
Study completion9 Aug 2018

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.
Other trials for Stress Disorders, Post-TraumaticStudies 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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 212 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02234622
Sponsor's protocol ID: D1487-R
Acronym: RELIEVE
Status last verified: Mar 2020
First submitted: 29 Aug 2014
Last updated: 17 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Outcomes of a Holistic Yoga Program Designed to Relieve PTSD (RELIEVE Trial)
ClinicalTrials.gov ID: NCT02234622
Acronym / sponsor ID: RELIEVE / D1487-R
Conditions: Stress Disorders, Post-Traumatic
Keywords: Stress Disorders, Post-Traumatic, Yoga, Veterans
Study type: Interventional
Recruitment status: Completed
Enrolment: 212 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 3 Aug 2015 (actual)
Primary completion: 9 Aug 2018 (actual)
Study completion: 9 Aug 2018 (actual)
First posted: 9 Sep 2014 (estimated)
Results: Posted 17 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Holistic Yoga Program	Experimental	Behavioral: Holistic Yoga ProgramThe Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
Wellness Lifestyle Program	Active comparator	Behavioral: Wellness Lifestyle ProgramThe Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Veterans and civilians will be eligible for inclusion if
they are age 18 or older,
have a Clinician Administered PTSD Scale-confirmed PTSD diagnosis,
and access to a working telephone for ease of contact during the course of the study.

Key exclusion criteria (6 listed)

severe medical conditions in which yoga is contraindicated;
active psychosis;
active suicidal intent;
moderate to severe cognitive impairment as determined by the short Mini-Mental State Examination, a six-item screener (MMSE);
involvement in ongoing yoga classes and/or regular home practice of yoga in the previous 3 months;

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
Holistic Yoga ProgramAlso: HYPThe Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.	Behavioural	Holistic Yoga Program
Wellness Lifestyle ProgramAlso: WLPThe Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.	Behavioural	Wellness Lifestyle Program

Primary outcome

Clinician Administered PTSD Scale (CAPS-5)
Time frame: Change from baseline to 16 weeks (end of treatment)
The CAPS is a semi-structured clinician administered interview that measures PTSD diagnostic status and symptom severity consistent with the Diagnostic and Statistical Manual-Fifth Edition. Scores range 0-80 with higher scores meaning a worse outcome.
PTSD Checklist
Time frame: Change from baseline to 16 weeks (end of treatment)
PTSD self-reported symptom severity will be assessed with the PTSD Checklist-5 (PCL-5), a 20-item self-report measure of the 5th version of the Diagnostic and Statistics Manual (DSM-5) symptoms of PTSD used as a measure of change in PTSD symptoms as a function of treatment. Scores range 0-80 with higher scores indicating worse outcome.

5 secondary outcomes

Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II
Time frame: Change from baseline to 16 weeks (end of treatment)
Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a
Time frame: Change from baseline to 16 weeks (end of treatment)
Beck Depression Inventory-II
Time frame: Change from baseline to 16 weeks (end of treatment)
Spielberger State-Trait Anxiety (STAI) - State Subscale
Time frame: Change from baseline to 16 weeks (end of treatment)
Brief Pain Inventory (BPI) Item #3
Time frame: Change from baseline to 16 weeks (end of treatment)

Results and safety

Results posted to the registry on 17 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Holistic Yoga Program	108	65
Wellness Lifestyle Program	104	68

Primary outcome: Clinician Administered PTSD Scale (CAPS-5)

Time frame: Change from baseline to 16 weeks (end of treatment). Mean (Standard Deviation). Unit: score on a scale

Measure	Holistic Yoga Program n = 108	Wellness Lifestyle Program n = 101
Value	25.8 (12.1)	31.0 (13.0)

Holistic Yoga Program vs Wellness Lifestyle Program: Mean Difference (Final Values): -5.0 (95% CI -8.2 to -1.8), p = 0.002, Mixed Models Analysis

Population analysed: three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria

Primary outcome: PTSD Checklist

Time frame: Change from baseline to 16 weeks (end of treatment). Mean (Standard Deviation). Unit: score on a scale

Measure	Holistic Yoga Program n = 108	Wellness Lifestyle Program n = 101
Value	33 (17.5)	40.2 (15.2)

Holistic Yoga Program vs Wellness Lifestyle Program: Mean Difference (Net): -6.1 (95% CI -10.3 to -1.8), p = 0.005, Mixed Models Analysis

Population analysed: three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Holistic Yoga Program	0 of 108 (0%)	0 of 108 (0%)	0 of 108
Wellness Lifestyle Program	0 of 104 (0%)	0 of 104 (0%)	0 of 104

Limitations and caveats (from the sponsor): All participants were from one large city in the Midwest. The yoga intervention was designed to address PTSD by a yoga therapist who trained the yoga teacher assistants and may not apply to all types of yoga classes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Louanne W Davis, PsyD principal investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Holistic Yoga Program and Wellness Lifestyle Program in people with Stress Disorders, Post-Traumatic, 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 4 inclusion and 6 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 17 Mar 2020. 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 17 Mar 2020). 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 (CAPS-5) (time frame: Change from baseline to 16 weeks (end of treatment)). The study lists 2 primary outcomes in all. 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 NCT02234622.

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 17 Mar 2020; AzTrials last refreshed its copy on 31 Oct 2026.