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This study is designed to test the effect of an explanation about the first sleep following trauma exposure, on the development of Post Traumatic Stress Disorder (PTSD) in the months following the traumatic event.
This is a Single blind, prospective, placebo controlled trial in which trauma victims are randomized to receive an explanation about the first sleep following trauma exposure.
To provide a baseline prior the explanation, participants will receive a medical and psychological evaluation. at this point the participants will be given one of two explanations about sleep. The experimental group will receive an encouragement to deprived sleep explanation, and the control group will receive an encouragement to sleep explanation, Lorazepam 1mg will be offered to assist sleep. After two weeks the research assistant or study psychiatrist will perform behavioral ratings and complete history details pertaining to PTSD risk factors. Participants will be assessed again by the study psychiatrist or research assistants at 1 & 3 months. Further assessments might be done at 6 & 13 months.
Eligible subjects will include men and women age 18-70, who have been exposed to an event meeting the DSM-IV "A.1" criterion for trauma exposure, and who provide written, informed consent to participate in the study.
Potential participants will be recruited from trauma victims who arrived at the Chaim Sheba Medical Center Emergency Room.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Encouragement to sleep | Placebo Comparator | Encouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma |
|
| Encouragement to deprived sleep | Experimental | Encouraging explanation to deprived sleep in the first night post trauma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Explanation encouraging sleep | Behavioral | An explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PTSD severity as measured by CAPS | The primary outcome is PTSD severity at the end of the trial .This will be determined using the Clinician Administered PTSD Scale (CAPS), a scale with established reliability and good psychometric properties. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Zohar, MD | Department of Psychiatry, Chaim Sheba Medical Center, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Explanation discouraging sleep | Behavioral | An explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event. |
|
| Lorazepam | Drug | Lorazepam 1 mg |
|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |