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Study terminated due to funding issues
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| Name | Class |
|---|---|
| The Dana Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sudarshan Kriya Yoga | Behavioral | SKY incorporates yoga, discussion periods and several types of breathing exercises for relaxation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician-Administered PTSD Scale (CAPS) scores | Baseline, 1 month post-intervention (approx. 6 weeks) | |
| Change in PTSD Checklist-Military (PCL-M) scores | 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. | Baseline, post-intervention (approx 10-14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of sleep | Sleep quality will be assessed using actigraphy | Baseline through one month post-intervention (approx. 6 weeks) |
| Changes in self-reported mood, anxiety, and sleep symptoms | Baseline, post-intervention (approx. 10-14 days), one month post-intervention (approx. 6 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard J Davidson, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Waisman Center, University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| D000099024 | Mindfulness-Based Stress Reduction |
| D064866 | Mindfulness |
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Mindfulness-Based Stress Reduction | Behavioral | 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 |
|
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| Changes in peripheral psychophysiological arousal | Assessed using multiple measures, including heart rate, heart rate variability, corrugator EMG, and skin conductance. | 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 | Baseline, post-intervention (approx. 10-14 days) |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D012064 | Relaxation Therapy |