Explanation About Sleep in Post Trauma Patients
Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Traumatic Stress Disorder; Sleep Deprivation
Intervention: Explanation encouraging sleep (Behavioral); Explanation discouraging sleep (Behavioral); Lorazepam (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Sheba Medical Center Official(s) and/or principal investigator(s): Joseph Zohar, MD, Principal Investigator, Affiliation: Department of Psychiatry, Chaim Sheba Medical Center, Israel
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.
Clinical Details
Official title: Explanation About Sleep Given After Traumatic Event, and Its Effect on the Trajectory of Post Traumatic Stress Disorder (PTSD)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: PTSD severity as measured by CAPS
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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. -
Locations and Contacts
Chaim Sheba Medical Center, Tel Hashomer 52621, Israel
Additional Information
Starting date: October 2012
Last updated: October 7, 2012
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