Explanation About Sleep in Post Trauma Patients
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Post Traumatic Stress Disorder Sleep Deprivation |
Intervention | Behavioral: Explanation encouraging sleep Behavioral: Explanation discouraging sleep Drug: Lorazepam |
Phase | N/A |
Sponsor | Sheba Medical Center |
Responsible Party | Sheba Medical Center |
ClinicalTrials.gov Identifier | NCT01684085 |
First Received | September 5, 2012 |
Last Updated | October 7, 2012 |
Last verified | October 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | September 5, 2012 |
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Last Updated Date | October 7, 2012 |
Start Date | October 2012 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | PTSD severity as measured by CAPS [Time Frame: 4 months] [Designated as safety issue: No]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. |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Explanation About Sleep in Post Trauma Patients |
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Official Title | Explanation About Sleep Given After Traumatic Event, and Its Effect on the Trajectory of Post Traumatic Stress Disorder (PTSD) |
Brief Summary | 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. |
Detailed Description | 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. |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention |
Condition |
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Intervention | Behavioral: Explanation encouraging sleep An explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep. Behavioral: Explanation discouraging sleep An explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event. Drug: Lorazepam Lorazepam 1 mg |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Not yet recruiting |
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Estimated Enrollment | 70 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | September 2014 |
Eligibility Criteria | Inclusion Criteria: 1. Persons age 18-70, who have been exposed to an event meeting the DSM-IV "A.1" criterion for trauma exposure. 2. Persons who arrived at the Chaim Sheba Medical Center Emergency Room. 3. Who provide written, informed consent to participate in the study - Exclusion Criteria: 1. Physical injury that would contraindicate participation or interfere with a subject's ability to give informed consent or cooperate with the screening or collection of initial measures. Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by clinical judgment; 2. Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period. 3. Overt psychopathology, intoxication, or under the influence of substances. 4. Evidence or history of schizophrenia, bipolar, other psychotic condition; 5. Prior history of PTSD; 6. Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure; 7. Assessed serious suicide risk. - |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Israel |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01684085 |
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Other Study ID Numbers | SHEBA-12-9175-JZ-CTIL |
Has Data Monitoring Committee | No |
Information Provided By | Sheba Medical Center |
Study Sponsor | Sheba Medical Center |
Collaborators | Not Provided |
Investigators | Principal Investigator: Joseph Zohar, MD Department of Psychiatry, Chaim Sheba Medical Center, Israel |
Verification Date | October 2012 |
Locations[ + expand ][ + ]
Chaim Sheba Medical Center | Tel Hashomer, Israel, 52621 |
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