Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder.
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|ClinicalTrials.gov Identifier: NCT00778960|
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : July 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorders||Behavioral: Slow Breathing Behavioral: Meditation Behavioral: Meditation and slow breathing Behavioral: Sitting Quietly||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder.|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
|Experimental: Slow Breathing Group||
Behavioral: Slow Breathing
The slowed breathing group will be trained on a breathing device, RESPeRATE, designed to reduce respiratory rate.They will practice with RESPeRATE once a week (for 6 weeks) in the laboratory with the research staff.
|Experimental: Meditation Group||
The Mindfulness Body Scan meditation will be used for the mindfulness meditation group.Participants will be trained once a week (for six weeks) in the laboratory by the research staff.
|Experimental: Meditation and Slow Breathing Group||
Behavioral: Meditation and slow breathing
A structured Mindfulness breathing will be guided by the research staff during the lab trainings. The participant will sit upright and attempt to focus attention on his or her own breath as it passes the opening of the nostrils or on the rising and falling of the abdomen or chest. Whenever attention wanders from the breath, the participant will simply notice the distracting thought and then let it go as attention is returned to the breath. Training will be given once every week for 6 weeks.
|Placebo Comparator: Sitting Quietly Group||
Behavioral: Sitting Quietly
The SQ control group's "intervention" will include sitting quietly and listening to a neutral-content book on tape to serve as a time and attention control at each laboratory session. They will also be asked to sit quietly at home daily.
- Attentional Network Task: conflict effect score [ Time Frame: Change from Baseline to Endpoint visit (one week after last training visit) ]
- Awakening cortisol values [ Time Frame: Change from Baseline to Endpoint visit (one week after last training visit) ]
- Post-traumatic stress disorder checklist-hyperarousal score [ Time Frame: Change from Baseline to Endpoint visit (one week after last training visit) ]
- Intrusive Thought Scale [ Time Frame: Change from Baseline to Endpoint visit (one week after last training visit) ]
- EEG event-related negativity during Attentional Network Task [ Time Frame: Change from Baseline to Endpoint visit (one week after last training visit) ]
- Heart rate [ Time Frame: Change from Baseline to Endpoint visit (one week after last training visit) ]
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): NCT00778960
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Helane Wahbeh, ND||Oregon Health and Science University|