Post Traumatic Stress DisorderNCT01684085
Explanation About Sleep in Post Trauma Patients
A study testing Explanation encouraging sleep, Explanation discouraging sleep and Lorazepam in people with Post Traumatic Stress Disorder and Sleep Deprivation, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Sleep Deprivation
- What is being tested?
- Explanation encouraging sleep, Explanation discouraging sleep and Lorazepam
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Explanation About Sleep Given After Traumatic Event, and Its Effect on the Trajectory of Post Traumatic Stress Disorder (PTSD)
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder, Sleep Deprivation
- Being tested
- Explanation encouraging sleep, Explanation discouraging sleep, Lorazepam
- Keywords
- sleep deprivation, PTSD,prevention
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explanation encouraging sleepBehavioural
An explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep.
Explanation discouraging sleepBehavioural
An explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event.
LorazepamDrug
Lorazepam 1 mg
| Study group | Role | What they receive |
|---|---|---|
| Encouragement to sleep | Placebo comparator | Encouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma Receives: Behavioral: Explanation encouraging sleep; Drug: Lorazepam |
| Encouragement to deprived sleep | Experimental | Encouraging explanation to deprived sleep in the first night post trauma Receives: Behavioral: Explanation discouraging sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Joseph Zohar, MD, Principal investigator, Department of Psychiatry, Chaim Sheba Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684085
- Sponsor's protocol ID
- SHEBA-12-9175-JZ-CTIL
- Status last verified
- Oct 2012
- First submitted
- 5 Sep 2012
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explanation About Sleep Given After Traumatic Event, and Its Effect on the Trajectory of Post Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT01684085
- Acronym / sponsor ID
- SHEBA-12-9175-JZ-CTIL
- Conditions
- Post Traumatic Stress Disorder, Sleep Deprivation
- Keywords
- sleep deprivation, PTSD,prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (estimated)
- First posted
- 12 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Encouragement to sleep | Placebo comparator | Behavioral: Explanation encouraging sleep, Drug: LorazepamEncouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma |
| Encouragement to deprived sleep | Experimental | Behavioral: Explanation discouraging sleepEncouraging explanation to deprived sleep in the first night post trauma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 -
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Explanation encouraging sleepAn explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep. | Behavioural | Encouragement to sleep |
| Explanation discouraging sleepAn explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event. | Behavioural | Encouragement to deprived sleep |
| LorazepamLorazepam 1 mg | Drug | Encouragement to sleep |
Primary outcome
PTSD severity as measured by CAPS
Time frame: 4 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Zohar, MD principal investigator
Department of Psychiatry, Chaim Sheba Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Explanation encouraging sleep, Explanation discouraging sleep and Lorazepam in people with Post Traumatic Stress Disorder and Sleep Deprivation, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD severity as measured by CAPS (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2012.