PTSDPhase 1/2NCT01521442
Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans
A Phase 1/2 study testing Mindful Yoga Therapy in people with PTSD, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for posttraumatic stress disorder (PTSD) among Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veterans. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- PTSD
- What is being tested?
- Mindful Yoga Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Nov 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- OEF/OIF/OND Veteran
- Ages 18-45
- Currently enrolled in active PTSD treatment
- Meet criteria for PTSD
- Veteran with combat exposure during deployment
Who cannot join
- Current psychotic disorder or bipolar disorder
- Current use of beta-blocker medication
- Current regular yoga or meditation practice in the past month
- Significant limitations or injuries
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans: A Pilot Study
The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for posttraumatic stress disorder (PTSD) among Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veterans. The current study also seeks to establish preliminary efficacy of Mindful Yoga Therapy for reduction of symptoms of PTSD and explore heart rate variability as a mechanism of therapeutic action.
Read the detailed description
PTSD is a chronic, debilitating anxiety disorder associated with disability, functional impairment, and a host of co-morbid physical and mental health conditions. Although several treatments are successful in treating Veterans with PTSD, many Veterans fail to complete these treatments and many others complete treatment without significant relief from symptoms. Yoga is one integrative treatment option that has shown promise for a number of physical and mental health conditions, including the treatment of depressive and anxiety disorders in civilian samples, and chronic pain in Veterans. Yoga is widely offered in Veterans Affairs (VA) PTSD Treatment Programs, yet there is a lack of research on its efficacy for PTSD in Veterans.
Mindful Yoga Therapy (MYT)is a 12-week treatment protocol incorporating meditation, breathing exercises, mindful movement practice, and guided rest (yoga nidra) that has been developed specifically for Veterans with PTSD. This pilot randomized clinical trial with cross-over waitlist comparison (RCT) will compare Immediate Mindful Yoga Therapy (MYT) plus Treatment as Usual (TAU) with Delayed MYT + TAU. Baseline (week 0), 12-week, and 24-week assessments, in addition to 36-week assessments for the delayed MYT treatment group, will include diagnostic, neurocognitive, and psychophysiological measures conducted by a research team member blinded to treatment condition.
Primary Aim: The primary aim of the current pilot study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for PTSD among OEF/OIF Veterans.
Specific Aim #1: To establish that MYT is a treatment that can be implemented safely. Hypothesis #1: There will be no significant difference in the number of adverse events between treatment groups from week 0 to week 12.
Specific Aim #2: To establish that MYT is a treatment that veterans find helpful and accessible. Hypothesis #2. At least 50% of participants completing the MYT treatment will report that the treatment was helpful and accessible as reported on self-report measures of treatment satisfaction, administered at the completion of the MYT treatment component of the study (week 12 for the immediate MYT treatment group; week 24 for the delayed MYT treatment group).
Secondary Aim: To assess the effect of Mindful Yoga Therapy as an adjunctive treatment on symptoms of PTSD is OEF/OIF Veterans.
Specific Aim #3: To examine the efficacy of MYT + TAU in reducing frequency and/or intensity of PTSD symptoms. Hypothesis #3. While both groups are expected to show reductions in symptoms, compared to participants in the Delayed MYT + TAU group, Veterans in the Immediate MYT + TAU group will exhibit significantly greater reductions in the frequency and/or intensity of PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS) (baseline to 12-week change). We predict that Immediate MYT+TAU will have a differential impact on the three PTSD symptom clusters, with the greatest effect on the hyperarousal symptoms.
Specific Aim #4. To document the durability of MYT treatment effects in the Immediate MYT group. Hypothesis #4. PTSD symptom scores will not be significantly different at 24-week assessment compared to those at week 12 assessment in the immediate MYT treatment group, and not significantly different at 36-week assessment compared to 24-week assessment for the delayed treatment group.
Tertiary Aim: To assess changes in heart rate variability from a resting baseline period and a guided meditation period in Veterans with PTSD before and after treatment with Mindful Yoga Therapy.
Specific Aim #5: To examine the predictive value of HRV on outcomes of Immediate MYT+TAU and Delayed MYT + TAU. Hypothesis #5. Increases in high frequency HRV (HF-HRV) from resting baseline to guided meditation at the pre-treatment assessment (week 0 for the immediate MYT treatment group, week 12 for the delayed MYT treatment group) will be associated with greater PTSD symptom reduction at post-treatment (week 12 for the immediate MYT treatment group; week 24 for delayed MYT treatment group).
- Conditions
- PTSD
- Being tested
- Mindful Yoga Therapy, Wait-list Control
- Keywords
- PTSD, Yoga, Complementary and Alternative Medicine (CAM)
- 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.
Mindful Yoga TherapyBehavioural
Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, mindful movement, and guided rest (yoga nidra), as well as daily home practice.
Wait-list ControlBehavioural
Participants will receive Mindful Yoga Therapy intervention after 12 weeks from being enrolled. Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, mindful movement, and guided rest (yoga nidra), as well as daily home practice.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each. Receives: Behavioral: Mindful Yoga Therapy |
| Arm 2 | Other | 12-week delay before beginning Mindful Yoga Therapy treatment which will consist of 12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each. Receives: Behavioral: Wait-list Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS)
The "gold standard" measure of frequency and intensity of PTSD symptoms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startApr 2013
- Primary completionSep 2015 (estimated)
- Study completionNov 2015 (estimated)
Why it stopped: Did not have funding or resources to carry out study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alicia Heapy, Ph.D., Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521442
- Sponsor's protocol ID
- 01540
- Status last verified
- Dec 2014
- First submitted
- 19 Jan 2012
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans: A Pilot Study
- ClinicalTrials.gov ID
- NCT01521442
- Acronym / sponsor ID
- 01540
- Conditions
- PTSD
- Keywords
- PTSD, Yoga, Complementary and Alternative Medicine (CAM)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not have funding or resources to carry out study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Apr 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for posttraumatic stress disorder (PTSD) among Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veterans. The current study also seeks to establish preliminary efficacy of Mindful Yoga Therapy for reduction of symptoms of PTSD and explore heart rate variability as a mechanism of therapeutic action.
Detailed description
PTSD is a chronic, debilitating anxiety disorder associated with disability, functional impairment, and a host of co-morbid physical and mental health conditions. Although several treatments are successful in treating Veterans with PTSD, many Veterans fail to complete these treatments and many others complete treatment without significant relief from symptoms. Yoga is one integrative treatment option that has shown promise for a number of physical and mental health conditions, including the treatment of depressive and anxiety disorders in civilian samples, and chronic pain in Veterans. Yoga is widely offered in Veterans Affairs (VA) PTSD Treatment Programs, yet there is a lack of research on its efficacy for PTSD in Veterans.
Mindful Yoga Therapy (MYT)is a 12-week treatment protocol incorporating meditation, breathing exercises, mindful movement practice, and guided rest (yoga nidra) that has been developed specifically for Veterans with PTSD. This pilot randomized clinical trial with cross-over waitlist comparison (RCT) will compare Immediate Mindful Yoga Therapy (MYT) plus Treatment as Usual (TAU) with Delayed MYT + TAU. Baseline (week 0), 12-week, and 24-week assessments, in addition to 36-week assessments for the delayed MYT treatment group, will include diagnostic, neurocognitive, and psychophysiological measures conducted by a research team member blinded to treatment condition.
Primary Aim: The primary aim of the current pilot study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for PTSD among OEF/OIF Veterans.
Specific Aim #1: To establish that MYT is a treatment that can be implemented safely. Hypothesis #1: There will be no significant difference in the number of adverse events between treatment groups from week 0 to week 12.
Specific Aim #2: To establish that MYT is a treatment that veterans find helpful and accessible. Hypothesis #2. At least 50% of participants completing the MYT treatment will report that the treatment was helpful and accessible as reported on self-report measures of treatment satisfaction, administered at the completion of the MYT treatment component of the study (week 12 for the immediate MYT treatment group; week 24 for the delayed MYT treatment group).
Secondary Aim: To assess the effect of Mindful Yoga Therapy as an adjunctive treatment on symptoms of PTSD is OEF/OIF Veterans.
Specific Aim #3: To examine the efficacy of MYT + TAU in reducing frequency and/or intensity of PTSD symptoms. Hypothesis #3. While both groups are expected to show reductions in symptoms, compared to participants in the Delayed MYT + TAU group, Veterans in the Immediate MYT + TAU group will exhibit significantly greater reductions in the frequency and/or intensity of PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS) (baseline to 12-week change). We predict that Immediate MYT+TAU will have a differential impact on the three PTSD symptom clusters, with the greatest effect on the hyperarousal symptoms.
Specific Aim #4. To document the durability of MYT treatment effects in the Immediate MYT group. Hypothesis #4. PTSD symptom scores will not be significantly different at 24-week assessment compared to those at week 12 assessment in the immediate MYT treatment group, and not significantly different at 36-week assessment compared to 24-week assessment for the delayed treatment group.
Tertiary Aim: To assess changes in heart rate variability from a resting baseline period and a guided meditation period in Veterans with PTSD before and after treatment with Mindful Yoga Therapy.
Specific Aim #5: To examine the predictive value of HRV on outcomes of Immediate MYT+TAU and Delayed MYT + TAU. Hypothesis #5. Increases in high frequency HRV (HF-HRV) from resting baseline to guided meditation at the pre-treatment assessment (week 0 for the immediate MYT treatment group, week 12 for the delayed MYT treatment group) will be associated with greater PTSD symptom reduction at post-treatment (week 12 for the immediate MYT treatment group; week 24 for delayed MYT treatment group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Mindful Yoga Therapy12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each. |
| Arm 2 | Other | Behavioral: Wait-list Control12-week delay before beginning Mindful Yoga Therapy treatment which will consist of 12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- OEF/OIF/OND Veteran
- Ages 18-45
- Currently enrolled in active PTSD treatment
- Meet criteria for PTSD
- Veteran with combat exposure during deployment
Key exclusion criteria (4 listed)
- Current psychotic disorder or bipolar disorder
- Current use of beta-blocker medication
- Current regular yoga or meditation practice in the past month
- Significant limitations or injuries
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 |
|---|---|---|
| Mindful Yoga TherapyVeterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, mindful movement, and guided rest (yoga nidra), as well as daily home practice. | Behavioural | Arm 1 |
| Wait-list ControlParticipants will receive Mindful Yoga Therapy intervention after 12 weeks from being enrolled. Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, mindful movement, and guided rest (yoga nidra), as well as daily home practice. | Behavioural | Arm 2 |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
Time frame: 12 weeks
The "gold standard" measure of frequency and intensity of PTSD symptoms.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
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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.
Alicia Heapy, Ph.D. principal investigator
VA Connecticut Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mindful Yoga Therapy in people with PTSD, run by VA Connecticut Healthcare System 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 19 Dec 2014. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2014.