Breathing Meditation Intervention for Post Traumatic Stress Disorder
Status: | Active, not recruiting |
---|---|
Conditions: | Psychiatric, Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/6/2019 |
Start Date: | October 14, 2015 |
End Date: | March 31, 2020 |
Breathing Meditation Intervention for Post-Traumatic Stress Disorder
Post traumatic stress disorder (PTSD) is a condition that develops as a result of exposure to
a traumatic event. The purpose of this study is to determine whether a breathing meditation
technique (Sudarshan Kriya Yoga; SKY) provides a treatment benefit that is as effective as
the standard intervention. Patients' PTSD symptoms will be monitored before treatment, at the
end of treatment, one month after treatment and 12 months after treatment.
a traumatic event. The purpose of this study is to determine whether a breathing meditation
technique (Sudarshan Kriya Yoga; SKY) provides a treatment benefit that is as effective as
the standard intervention. Patients' PTSD symptoms will be monitored before treatment, at the
end of treatment, one month after treatment and 12 months after treatment.
Post traumatic stress disorder (PTSD) is a condition that develops as a result of exposure to
a traumatic event and is characterized by intense physiological and psychological reactivity
to stimuli associated with that trauma. PTSD represents a substantial proportion of the
burden of illness among Veterans. A recent study found that PTSD was diagnosed in 13% of
Veterans returning from Iraq and Afghanistan. Recent reports have also highlighted that PTSD
is associated with suicidality - a fact that may explain the alarming rise of suicidal
behavior amongst returning Veterans. Several studies suggest that meditation-based treatments
may be helpful in treating PTSD. Sudarshan Kriya Yoga (SKY) is a meditation technique that
involves a sequence of breathing exercises and has shown promise in treating PTSD. There are
several lines of evidence to suggest that such meditation techniques provide a solid
foundation for treating PTSD. First, breathing meditation techniques offer a powerful method
for balancing autonomic nervous system activity that is often heightened in PTSD. Second,
they promote the relaxation response that counters hyperarousal and results in a calmer
approach to difficulties and challenges. Third, they may improve sleep quality. This may be
important in treating PTSD because memories are encoded into long-term storage during sleep
via a process known as consolidation. It is possible that the disturbed sleep which is common
in PTSD (nightmares and insomnia) lead to disrupted memory consolidation. Therefore
improvement in sleep may lead to improvement in PTSD.
Despite promising findings, meditation has not been sufficiently studied in Veterans to
recommend its widespread use in treating PTSD. The goal of this proposal is to examine the
effects of SKY meditation therapy on Veterans with clinically significant PTSD symptoms. SKY
intervention will be compared to cognitive processing therapy (CPT) that is commonly used to
treat Veterans with PTSD. CPT will be given as a "cognitive only" version (CPT-C) which is
efficacious in treating PTSD. Veterans will be randomly assigned to one of the two groups
(SKY, CPT-C; n=38 per group) and treatment will be delivered over a six-week period. A
"noninferiority" experimental design will be used as is appropriate for trials in which the
primary objective is to show that a novel intervention (SKY) is as effective as the standard
intervention. Patients' PTSD symptoms will be monitored across time; before treatment (i.e.,
baseline), at the end of treatment, one month after treatment and 12 months after treatment.
Other measures will be taken at baseline and at the end of treatment, and will include
autonomic arousal (heart rate) and cognitive functioning including memory consolidation. The
investigators will also monitor dropout rates as these can be high in conventional PTSD
treatment programs. Based on preliminary studies using SKY in Veterans with PTSD and the
existing literature, the investigators expect that PTSD symptom severity will be reduced
following treatment with SKY, that this effect will not be clinically inferior to CPT-C and
that the dropout rates will be no higher than CPT-C. Such findings would provide strong
evidence for the efficacy of SKY in treating Veterans with PTSD. The investigators also
expect that improvements in clinical measures of PTSD will correlate with improvements in
memory consolidation, reflecting improvements in sleep following treatment. It is also likely
that the individual's response to treatment will be influenced by their baseline
characteristics. The SKY and CBT-C interventions focus on different aspects of PTSD; the SKY
intervention focuses on breathing and relaxation techniques whereas CPT-C focuses on
modifying the understanding of trauma through cognitive restructuring. For this reason the
SKY intervention may be more effective for Veterans who have exaggerated arousal (e.g.
heightened heart rate). In contrast the CPT-C intervention may be more effective for Veterans
who have more cognitive symptoms (e.g., flashbacks, attentional difficulties) since CPT-C
addresses cognitive processes. The long term goal of this project is to conduct a
fully-powered multi-center randomized controlled clinical trial of SKY meditation in
Veterans.
a traumatic event and is characterized by intense physiological and psychological reactivity
to stimuli associated with that trauma. PTSD represents a substantial proportion of the
burden of illness among Veterans. A recent study found that PTSD was diagnosed in 13% of
Veterans returning from Iraq and Afghanistan. Recent reports have also highlighted that PTSD
is associated with suicidality - a fact that may explain the alarming rise of suicidal
behavior amongst returning Veterans. Several studies suggest that meditation-based treatments
may be helpful in treating PTSD. Sudarshan Kriya Yoga (SKY) is a meditation technique that
involves a sequence of breathing exercises and has shown promise in treating PTSD. There are
several lines of evidence to suggest that such meditation techniques provide a solid
foundation for treating PTSD. First, breathing meditation techniques offer a powerful method
for balancing autonomic nervous system activity that is often heightened in PTSD. Second,
they promote the relaxation response that counters hyperarousal and results in a calmer
approach to difficulties and challenges. Third, they may improve sleep quality. This may be
important in treating PTSD because memories are encoded into long-term storage during sleep
via a process known as consolidation. It is possible that the disturbed sleep which is common
in PTSD (nightmares and insomnia) lead to disrupted memory consolidation. Therefore
improvement in sleep may lead to improvement in PTSD.
Despite promising findings, meditation has not been sufficiently studied in Veterans to
recommend its widespread use in treating PTSD. The goal of this proposal is to examine the
effects of SKY meditation therapy on Veterans with clinically significant PTSD symptoms. SKY
intervention will be compared to cognitive processing therapy (CPT) that is commonly used to
treat Veterans with PTSD. CPT will be given as a "cognitive only" version (CPT-C) which is
efficacious in treating PTSD. Veterans will be randomly assigned to one of the two groups
(SKY, CPT-C; n=38 per group) and treatment will be delivered over a six-week period. A
"noninferiority" experimental design will be used as is appropriate for trials in which the
primary objective is to show that a novel intervention (SKY) is as effective as the standard
intervention. Patients' PTSD symptoms will be monitored across time; before treatment (i.e.,
baseline), at the end of treatment, one month after treatment and 12 months after treatment.
Other measures will be taken at baseline and at the end of treatment, and will include
autonomic arousal (heart rate) and cognitive functioning including memory consolidation. The
investigators will also monitor dropout rates as these can be high in conventional PTSD
treatment programs. Based on preliminary studies using SKY in Veterans with PTSD and the
existing literature, the investigators expect that PTSD symptom severity will be reduced
following treatment with SKY, that this effect will not be clinically inferior to CPT-C and
that the dropout rates will be no higher than CPT-C. Such findings would provide strong
evidence for the efficacy of SKY in treating Veterans with PTSD. The investigators also
expect that improvements in clinical measures of PTSD will correlate with improvements in
memory consolidation, reflecting improvements in sleep following treatment. It is also likely
that the individual's response to treatment will be influenced by their baseline
characteristics. The SKY and CBT-C interventions focus on different aspects of PTSD; the SKY
intervention focuses on breathing and relaxation techniques whereas CPT-C focuses on
modifying the understanding of trauma through cognitive restructuring. For this reason the
SKY intervention may be more effective for Veterans who have exaggerated arousal (e.g.
heightened heart rate). In contrast the CPT-C intervention may be more effective for Veterans
who have more cognitive symptoms (e.g., flashbacks, attentional difficulties) since CPT-C
addresses cognitive processes. The long term goal of this project is to conduct a
fully-powered multi-center randomized controlled clinical trial of SKY meditation in
Veterans.
Inclusion Criteria:
- Veteran from any conflict era
- Symptoms of Posttraumatic Stress Disorder measured during study screening
Exclusion Criteria:
- planning on starting a new course of behavioral therapy during the trial
- started new medication for PTSD within 8 weeks of the study screening
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Peter J Bayley, PhD
Phone: 650-493-5000
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