Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder
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|ClinicalTrials.gov Identifier: NCT01512303|
Recruitment Status : Suspended (Study on hold due to funding issues)
First Posted : January 19, 2012
Last Update Posted : March 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Behavioral: Sudarshan Kriya Yoga Behavioral: Mindfulness-Based Stress Reduction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder: Community Program Evaluation Study|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||April 2017|
Experimental: Sudarshan Kriya Yoga: SKY
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).
Behavioral: Sudarshan Kriya Yoga
SKY incorporates yoga, discussion periods and several types of breathing exercises for relaxation.
Experimental: Mindfulness-Based Stress Reduction: MBSR
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).
Behavioral: Mindfulness-Based Stress Reduction
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
No Intervention: Wait-List Control: WLC
Participants will undergo no intervention. These participants will have the option of receiving one of the two interventions at the conclusion of the study.
No Intervention: Non-PTSD control
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.
- 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.
- Quality of sleep [ Time Frame: Baseline through one month post-intervention (approx. 6 weeks) ]Sleep quality will be assessed using actigraphy
- 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) ]Assessed using multiple measures, including heart rate, heart rate variability, corrugator EMG, and skin conductance.
- Changes in neuropsychological functioning [ Time Frame: Baseline, post-intervention (approx. 10-14 days) ]Memory, attention, and rapid perceptual processing will be measured using neuropsychological tasks by Cambridge Cognition and/or the NIH toolbox
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512303
|United States, Wisconsin|
|Waisman Center, University of Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Emma M Seppala, PhD||University of Wisconsin, Madison|