Post-Traumatic Stress Disorders Clinical Trial
Official title:
Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder.
The purpose of this study is to find out how meditation influences certain systems in the body: nervous system, hormonal system, and respiratory system. Another purpose is to see how meditation may help improve post-traumatic stress disorder symptoms.
This study requires nine visits to the clinic: one screening visit, one baseline visit, six
training sessions, and one endpoint visit. There will be approximately 100 people enrolled
in this study who will be randomly allocated to one of four groups: a slow breathing group,
a meditation group, a meditation plus slow breathing group and a sitting quietly group.
Participants will undergo a telephone screening, a screening visit, baseline visit, six
intervention visits (once per week for six weeks), and one endpoint visit (one week after
the final training visit). A telephone screening and screening visit will ensure participant
eligibility. The screening visit included structured clinician interviews on PTSD symptoms
and other mental health disorders, completion of questionnaires, and receipt of home saliva
collection kit. At the baseline visit, electrodes will be attached to measure the electrical
activity of head, chest, skin, and respiration and blood pressure during a computer task.
Intervention visits include slow breathing, meditation, mediation and slow breathing, or
sitting quietly depending on which group the participant is allocated to. Breathing rates
and other electrical activity of the body will be measured also. Breathing rate will be
measured with an elastic band that is placed around the chest. Electrical activity will be
measured by the electrodes that will be placed on the scalp, chest and skin. The endpoint
visit will be exactly the same as the baseline visit.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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