PTSDNCT01512303
Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder
A study testing Sudarshan Kriya Yoga and Mindfulness-Based Stress Reduction in people with PTSD, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The overarching aim of this proposal is to research whether meditation-based treatments are effective in decreasing posttraumatic stress disorder (PSTD) symptoms in veterans, which complementary and alternative (CA) treatments are most effective, and how individual differences predict treatment efficacy. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Sudarshan Kriya Yoga and Mindfulness-Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to May 2013
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In the age range of 18-50.
- Capable of giving informed consent
- Fluent in English
- Exposure to one or more life-threatening war zone trauma events in Iraq or Afghanistan within the last 8 years.
- Pharmacological or psychotherapeutic treatment stable for at least 8 weeks prior to beginning of study
- Good general medical health (see Medical Exclusion Criteria)
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- DSM-IV criteria for current PTSD as determined by CAPS (PTSD groups only)
- Combat-exposed, non-PTSD control veterans must be free of any current DSM-IV Axis I disorder
- Participants must agree to not begin a new course of treatment for the duration of the study
Who cannot join
- Weight of 352 pounds or over (due to constraints of MRI scanner)
- Women who are pregnant, planning to conceive during the research timeline, or breastfeeding will be excluded.
- Metallic implants such as prostheses or aneurysm clip, or electronic implants such as cardiac pacemakers
- Neurological or serious medical condition that may contraindicate MRI or that may overlap with physiological substrates of psychiatric conditions (see below for descriptions)
- History of seizures or seizure disorder
- Moderate or severe traumatic brain injury (over 30 minutes unconscious)
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- Current active substance dependence or dependence within 3 months (other than nicotine)
- Meets DSM-IV criteria for bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder NOS, delirium, or any DSM-IV cognitive disorder.
- Substance dependence disorder within 3 months or any current substance dependence
- Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior that poses an immediate danger to patient or others.
- Current use of benzodiazepines or beta-blockers
- Nonsuicidal depression comorbid with PTSD will NOT be exclusionary
- Extensive experience in yoga and meditation or have learned MBSR or SKY previously
Trial locations and contacts
1 site in 1 country.
United States1 site
Waisman Center, University of Wisconsin
Madison, Wisconsin, 53705
About this study
Official title: Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder: Community Program Evaluation Study
The overarching aim of this proposal is to research whether meditation-based treatments are effective in decreasing posttraumatic stress disorder (PSTD) symptoms in veterans, which complementary and alternative (CA) treatments are most effective, and how individual differences predict treatment efficacy.
Read the detailed description
The overarching purpose of this study is to assess the impact of CA interventions on posttraumatic stress symptoms in veterans with PTSD. Twenty percent of the approximately 2 million veterans returning from Iraq and Afghanistan ("Operation Iraqi Freedom" or OIF and "Operation Enduring Freedom" or OEF) suffer from the symptoms of Post-traumatic Stress Disorder. PTSD may be the reason behind alarming increases in suicidal behavior among returning veterans in Wisconsin and nation-wide. In addition to traditional treatments, Veterans Administration (VA) Hospitals and other community institutions for veterans now offer CA programs to their patients. Past research from our laboratory and others suggests that CA programs may provide effective relief from anxiety while increasing psychological well-being. However, little research exists on the effects of CA programs for combat veterans with PTSD. The proposed study aims to address this important gap by assessing CA programs such as Sudarshan Kriya Yoga (SKY) and Mindfulness-Based Stress Reduction (MBSR). 150 veterans with PTSD will be randomly assigned to either SKY, MBSR, or the wait-list control (WLC) group. We will assess participants' PTSD symptoms pre-intervention, post-intervention (approximately 10-14 days after initial visit), and 1 month post-treatment (approximately 6 weeks after initial visit). In order to evaluate the programs' effects as comprehensively as possible, we propose a multi-method approach: baseline psychophysiology, autonomic reactivity and recovery, neuropsychological (cognitive) assessments, self-report questionnaires, and functional brain imaging (fMRI). Baseline measures will be collected from a group of 50 combat-exposed veterans without PTSD to assess group differences on these measures prior to treatment.
- Conditions
- PTSD
- Being tested
- Sudarshan Kriya Yoga, Mindfulness-Based Stress Reduction
- Keywords
- PTSD, Veterans' Health, Meditation, MRI, Functional
- 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.
Sudarshan Kriya YogaBehavioural
Also called SKY, yoga
SKY incorporates yoga, discussion periods and several types of breathing exercises for relaxation.
Mindfulness-Based Stress ReductionBehavioural
Also called MBSR, mindfulness, meditation
MBSR incorporates yoga, discussion periods, and several types of meditation, all involving attention to the present moment and acceptance of any feelings, sensations or thoughts
| Study group | Role | What they receive |
|---|---|---|
| Sudarshan Kriya Yoga: SKY | Experimental | SKY incorporates yoga, discussion periods and several types of breathing exercises for relaxation. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment. All are soothing and present-focused. Participants will be encouraged to learn all the breathing exercises, and to utilize the exercises the ones that seems most appropriate for their needs. 8-day intensive group class (2.5 hours/day) followed by 4 weekly sessions (3 hours/session). Receives: Behavioral: Sudarshan Kriya Yoga |
| Mindfulness-Based Stress Reduction: MBSR | Experimental | MBSR incorporates yoga, discussion periods, and several types of meditation, all involving attention to the present moment and acceptance of any feelings, sensations or thoughts, allowing the practitioner to calm his or her mind and come back to the present moment. The typical MBSR format will be adapted to match the SKY intervention. This intervention will include an 8-day intensive group class (2.5 hours/day) followed by 4 weekly sessions (3hrs/session). Receives: Behavioral: Mindfulness-Based Stress Reduction |
| Wait-List Control: WLC | No intervention | Participants will undergo no intervention. These participants will have the option of receiving one of the two interventions at the conclusion of the study. |
| Non-PTSD control | No intervention | Baseline measures only will be collected from a group of 50 combat-exposed veterans without PTSD to assess group differences on these measures prior to treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician-Administered PTSD Scale (CAPS) scores
Measured: Baseline, 1 month post-intervention (approx. 6 weeks)
Change in PTSD Checklist-Military (PCL-M) scores
Measured: Baseline, Post-Intervention (approx. 10-14 days), 1 month post-intervention (approx. 6 weeks)
Change in fMRI brain blood oxygen level-dependent (BOLD) responses
Brain activation during anticipation of, response to, and recovery from aversive stimuli will be measured at baseline, and the intervention groups will be compared to the wait-list controls following the intervention to assess changes based on the interventions.
Measured: Baseline, post-intervention (approx 10-14 days)
Secondary outcomes (4)
Quality of sleep
Sleep quality will be assessed using actigraphy
Measured: Baseline through one month post-intervention (approx. 6 weeks)
Changes in self-reported mood, anxiety, and sleep symptoms
Measured: Baseline, post-intervention (approx. 10-14 days), one month post-intervention (approx. 6 weeks)
Changes in peripheral psychophysiological arousal
Assessed using multiple measures, including heart rate, heart rate variability, corrugator EMG, and skin conductance.
Measured: Baseline and post-intervention (approx. 10-14 days)
Changes in neuropsychological functioning
Memory, attention, and rapid perceptual processing will be measured using neuropsychological tasks by Cambridge Cognition and/or the NIH toolbox
Measured: Baseline, post-intervention (approx. 10-14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Study terminated due to funding issues
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- The Dana Foundation
- Responsible party
- Sponsor
- Investigators
- Richard J Davidson, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512303
- Sponsor's protocol ID
- 2011-0641
- Status last verified
- May 2018
- First submitted
- 6 Jan 2012
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder: Community Program Evaluation Study
- ClinicalTrials.gov ID
- NCT01512303
- Acronym / sponsor ID
- 2011-0641
- Conditions
- PTSD
- Keywords
- PTSD, Veterans' Health, Meditation, MRI, Functional
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to funding issues
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- The Dana Foundation
- Study start
- Apr 2012 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 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 overarching aim of this proposal is to research whether meditation-based treatments are effective in decreasing posttraumatic stress disorder (PSTD) symptoms in veterans, which complementary and alternative (CA) treatments are most effective, and how individual differences predict treatment efficacy.
Detailed description
The overarching purpose of this study is to assess the impact of CA interventions on posttraumatic stress symptoms in veterans with PTSD. Twenty percent of the approximately 2 million veterans returning from Iraq and Afghanistan ("Operation Iraqi Freedom" or OIF and "Operation Enduring Freedom" or OEF) suffer from the symptoms of Post-traumatic Stress Disorder. PTSD may be the reason behind alarming increases in suicidal behavior among returning veterans in Wisconsin and nation-wide. In addition to traditional treatments, Veterans Administration (VA) Hospitals and other community institutions for veterans now offer CA programs to their patients. Past research from our laboratory and others suggests that CA programs may provide effective relief from anxiety while increasing psychological well-being. However, little research exists on the effects of CA programs for combat veterans with PTSD. The proposed study aims to address this important gap by assessing CA programs such as Sudarshan Kriya Yoga (SKY) and Mindfulness-Based Stress Reduction (MBSR). 150 veterans with PTSD will be randomly assigned to either SKY, MBSR, or the wait-list control (WLC) group. We will assess participants' PTSD symptoms pre-intervention, post-intervention (approximately 10-14 days after initial visit), and 1 month post-treatment (approximately 6 weeks after initial visit). In order to evaluate the programs' effects as comprehensively as possible, we propose a multi-method approach: baseline psychophysiology, autonomic reactivity and recovery, neuropsychological (cognitive) assessments, self-report questionnaires, and functional brain imaging (fMRI). Baseline measures will be collected from a group of 50 combat-exposed veterans without PTSD to assess group differences on these measures prior to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sudarshan Kriya Yoga: SKY | Experimental | Behavioral: Sudarshan Kriya YogaSKY incorporates yoga, discussion periods and several types of breathing exercises for relaxation. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment. All are soothing and present-focused. Participants will be encouraged to learn all the breathing exercises, and to utilize the exercises the ones that seems most appropriate for their needs. 8-day intensive group class (2.5 hours/day) followed by 4 weekly sessions (3 hours/session). |
| Mindfulness-Based Stress Reduction: MBSR | Experimental | Behavioral: Mindfulness-Based Stress ReductionMBSR incorporates yoga, discussion periods, and several types of meditation, all involving attention to the present moment and acceptance of any feelings, sensations or thoughts, allowing the practitioner to calm his or her mind and come back to the present moment. The typical MBSR format will be adapted to match the SKY intervention. This intervention will include an 8-day intensive group class (2.5 hours/day) followed by 4 weekly sessions (3hrs/session). |
| Wait-List Control: WLC | No intervention | –Participants will undergo no intervention. These participants will have the option of receiving one of the two interventions at the conclusion of the study. |
| Non-PTSD control | No intervention | –Baseline measures only will be collected from a group of 50 combat-exposed veterans without PTSD to assess group differences on these measures prior to treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- In the age range of 18-50.
- Capable of giving informed consent
- Fluent in English
- Exposure to one or more life-threatening war zone trauma events in Iraq or Afghanistan within the last 8 years.
- Pharmacological or psychotherapeutic treatment stable for at least 8 weeks prior to beginning of study
Key exclusion criteria (13 listed)
- Weight of 352 pounds or over (due to constraints of MRI scanner)
- Women who are pregnant, planning to conceive during the research timeline, or breastfeeding will be excluded.
- Metallic implants such as prostheses or aneurysm clip, or electronic implants such as cardiac pacemakers
- Neurological or serious medical condition that may contraindicate MRI or that may overlap with physiological substrates of psychiatric conditions (see below for descriptions)
- History of seizures or seizure disorder
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 |
|---|---|---|
| Sudarshan Kriya YogaAlso: SKY, yogaSKY incorporates yoga, discussion periods and several types of breathing exercises for relaxation. | Behavioural | Sudarshan Kriya Yoga: SKY |
| Mindfulness-Based Stress ReductionAlso: MBSR, mindfulness, meditationMBSR incorporates yoga, discussion periods, and several types of meditation, all involving attention to the present moment and acceptance of any feelings, sensations or thoughts | Behavioural | Mindfulness-Based Stress Reduction: MBSR |
Primary outcome
Change in Clinician-Administered PTSD Scale (CAPS) scores
Time frame: Baseline, 1 month post-intervention (approx. 6 weeks)
Change in PTSD Checklist-Military (PCL-M) scores
Time frame: Baseline, Post-Intervention (approx. 10-14 days), 1 month post-intervention (approx. 6 weeks)
Change in fMRI brain blood oxygen level-dependent (BOLD) responses
Time frame: Baseline, post-intervention (approx 10-14 days)
Brain activation during anticipation of, response to, and recovery from aversive stimuli will be measured at baseline, and the intervention groups will be compared to the wait-list controls following the intervention to assess changes based on the interventions.
4 secondary outcomes
Quality of sleep
Time frame: Baseline through one month post-intervention (approx. 6 weeks)
Changes in self-reported mood, anxiety, and sleep symptoms
Time frame: Baseline, post-intervention (approx. 10-14 days), one month post-intervention (approx. 6 weeks)
Changes in peripheral psychophysiological arousal
Time frame: Baseline and post-intervention (approx. 10-14 days)
Changes in neuropsychological functioning
Time frame: Baseline, post-intervention (approx. 10-14 days)
Results and safety
The study was stopped early (reason given: Study terminated due to funding issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
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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.
Richard J Davidson, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sudarshan Kriya Yoga and Mindfulness-Based Stress Reduction in people with PTSD, run by University of Wisconsin, Madison 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 9 inclusion and 13 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: stopped early, as of the sponsor's last update on 7 May 2018. 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?
The study was stopped early (reason given: Study terminated due to funding issues). Results are not available in the source record.
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?
Change in Clinician-Administered PTSD Scale (CAPS) scores (time frame: Baseline, 1 month post-intervention (approx. 6 weeks)). The study lists 3 primary outcomes in all. 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 7 May 2018; AzTrials last refreshed its copy on 29 Oct 2026.