Explanation About Sleep in Post Trauma Patients

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01684085
• Other study ID #: SHEBA-12-9175-JZ-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: September 5, 2012
• Last updated: October 7, 2012
• Start date: October 2012

Study information

• Verified date: October 2012
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Sleep Deprivation
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

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.
• 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

Locations

Country	Name	City	State
Israel	Chaim Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months	No