Explanation About Sleep in Post Trauma Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01684085
First received: September 5, 2012
Last updated: October 7, 2012
Last verified: October 2012
  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)

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

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.


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
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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684085

Locations
Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
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
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014