Explanation About Sleep in Post Trauma Patients
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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.
| Condition | Intervention |
|---|---|
|
Post Traumatic Stress Disorder Sleep Deprivation |
Behavioral: Explanation encouraging sleep Behavioral: Explanation discouraging sleep Drug: Lorazepam |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Explanation About Sleep Given After Traumatic Event, and Its Effect on the Trajectory of Post Traumatic Stress Disorder (PTSD) |
- 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.
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2012 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Encouragement to sleep
Encouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma
|
Behavioral: Explanation encouraging sleep
An explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep.
Drug: Lorazepam
Lorazepam 1 mg
|
|
Experimental: Encouragement to deprived sleep
Encouraging explanation to deprived sleep in the first night post trauma
|
Behavioral: Explanation discouraging sleep
An explanation about sleep will be given, discouraging the patient from sleeping in the first night after 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Persons age 18-70, who have been exposed to an event meeting the DSM-IV "A.1" criterion for trauma exposure.
- Persons who arrived at the Chaim Sheba Medical Center Emergency Room.
- Who provide written, informed consent to participate in the study -
Exclusion Criteria:
- 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;
- Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period.
- Overt psychopathology, intoxication, or under the influence of substances.
- Evidence or history of schizophrenia, bipolar, other psychotic condition;
- Prior history of PTSD;
- Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure;
- Assessed serious suicide risk. -
Contacts and Locations| Israel | |
| Chaim Sheba Medical Center | |
| Tel Hashomer, Israel, 52621 | |
| Principal Investigator: | Joseph Zohar, MD | Department of Psychiatry, Chaim Sheba Medical Center, Israel |
More Information
No publications provided
| Responsible Party: | Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT01684085 History of Changes |
| Other Study ID Numbers: | SHEBA-12-9175-JZ-CTIL |
| Study First Received: | September 5, 2012 |
| Last Updated: | October 7, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Sheba Medical Center:
|
sleep deprivation, PTSD,prevention |
Additional relevant MeSH terms:
|
Sleep Deprivation Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Dyssomnias Sleep Disorders Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Anxiety Disorders Lorazepam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 21, 2013