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Explanation About Sleep in Post Trauma Patients

Primary Purpose

Post Traumatic Stress Disorder, Sleep Deprivation

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Explanation encouraging sleep

Explanation discouraging sleep

Lorazepam

About this trial

This is an interventional prevention trial for Post Traumatic Stress Disorder focused on measuring sleep deprivation, PTSD,prevention

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. -

Sites / Locations

Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Encouragement to sleep

Encouragement to deprived sleep

Arm Description

Encouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma

Encouraging explanation to deprived sleep in the first night post trauma

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01684085

First Posted

September 5, 2012

Last Updated

October 7, 2012

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01684085

Brief Title

Explanation About Sleep in Post Trauma Patients

Official Title

Explanation About Sleep Given After Traumatic Event, and Its Effect on the Trajectory of Post Traumatic Stress Disorder (PTSD)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sheba Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Traumatic Stress Disorder, Sleep Deprivation

Keywords

sleep deprivation, PTSD,prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Encouragement to sleep

Arm Type

Placebo Comparator

Arm Description

Encouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma

Arm Title

Encouragement to deprived sleep

Arm Type

Experimental

Arm Description

Encouraging explanation to deprived sleep in the first night post trauma

Intervention Type

Behavioral

Intervention Name(s)

Explanation encouraging sleep

Intervention Description

An explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep.

Intervention Type

Behavioral

Intervention Name(s)

Explanation discouraging sleep

Intervention Description

An explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event.

Intervention Type

Drug

Intervention Name(s)

Lorazepam

Intervention Description

Lorazepam 1 mg

Primary Outcome Measure Information:

Title

PTSD severity as measured by CAPS

Description

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Zohar, MD

Organizational Affiliation

Department of Psychiatry, Chaim Sheba Medical Center, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chaim Sheba Medical Center

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

12. IPD Sharing Statement

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Explanation About Sleep in Post Trauma Patients

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