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| ID | Type | Description | Link |
|---|---|---|---|
| K01AT004951-01 | U.S. NIH Grant/Contract | View source | |
| 4692 |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Oregon Clinical and Translational Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slow Breathing Group | Experimental |
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| Meditation Group | Experimental |
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| Meditation and Slow Breathing Group | Experimental |
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| Sitting Quietly Group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slow Breathing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Attentional Network Task: conflict effect score | Change from Baseline to Endpoint visit (one week after last training visit) | |
| Awakening cortisol values | Change from Baseline to Endpoint visit (one week after last training visit) | |
| Post-traumatic stress disorder checklist-hyperarousal score | Change from Baseline to Endpoint visit (one week after last training visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Intrusive Thought Scale | Change from Baseline to Endpoint visit (one week after last training visit) | |
| EEG event-related negativity during Attentional Network Task | Change from Baseline to Endpoint visit (one week after last training visit) |
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Inclusion Criteria:
Exclusion Criteria:
Significant chronic medical illness including:
Psychiatric or behavioral illness including:
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| Name | Affiliation | Role |
|---|---|---|
| Helane Wahbeh, ND | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | 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 |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Meditation | Behavioral | 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. |
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| Meditation and slow breathing | Behavioral | 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. |
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| Sitting Quietly | Behavioral | 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. |
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| Heart rate | Change from Baseline to Endpoint visit (one week after last training visit) |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |