Stress Disorder - Post-traumatic (Acute)NCT00889005
Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy
A study testing Telephone Based Cognitive Behavioral Therapy in people with Stress Disorder - Post-traumatic (Acute), run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This is a randomized controlled study comparing telephone-based cognitive behavioral therapy (CBT) for recent survivors of traumatic events with Acute Stress Disorder (ASD) or acute PTSD with a waitlist control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorder - Post-traumatic (Acute)
- What is being tested?
- Telephone Based Cognitive Behavioral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteIsrael
- Study dates
- May 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults
- Exposure to psychologically traumatic events
- Diagnosis of Acute Stress Disorder or Post-traumatic Stress Disorder
- Up to four weeks after trauma exposure
Who cannot join
- Chronic PTSD
- Past and present psychosis, bipolar disorder, opiate or stimulants use
- Medical or surgical condition that interfere with subjects ability to participate in the study or sign an informed consent
- Lack of fluency in the study's main language (Hebrew)
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled study comparing telephone-based cognitive behavioral therapy (CBT) for recent survivors of traumatic events with Acute Stress Disorder (ASD) or acute PTSD with a waitlist control group. Survivors with PTSD from both groups will receive face-to-face CBT one month from the traumatic event. The study's main hypothesis is that early telephone-based CBT will reduce the prevalence of PTSD three and eight months after the traumatic event.
Read the detailed description
Post-traumatic Stress Disorder (PTSD) is a prevalent and pervasive mental disorder. Studies have shown that there is a significant reluctance to use mental health services by trauma-exposed individuals at high risk for developing PTSD. Providing clinical services in combat or disaster zone might be difficult. Trauma-focused cognitive behavioral therapy (CBT) effectively reduces the prevalence of PTSD among recent survivors. Telephone based CBT was found to be effective in mood and anxiety disorders, but has not been tried in PTSD. Establishing the effectiveness of telephone based CBT has significant service delivery and public health implications. Preventing PTSD significantly reduces individuals' suffering and disability We will screen, by telephone, up to 1200 survivors of traumatic events, from a general hospital emergency department trauma registry list, randomize the first 240 with ASD or Acute PTSD to either early, telephone based cognitive behavioral therapy (ET_CBT) (n=120) or a no-treatment control condition (n=120). We will provide five sessions of ET-CBT to the former and compare the two groups three and eight months later.
Survivors from both groups who will continue to have PTSD at three months (after either treatment or waiting list), will receive 12 sessions of face-to-face, trauma focused CBT. A first phase of the study will consist of establishing the acceptance of ET-CBT and its main components (e.g., exposure to traumatic reminders) by survivors, and optimizing the protocol. It will involve 20 survivors and no randomization. Subsequent to that phase we will start recruiting for the main study. The study's main hypothesis is that early CBT will reduce the prevalence of PTSD three and eight months after the traumatic event.
- Conditions
- Stress Disorder - Post-traumatic (Acute)
- Being tested
- Telephone Based Cognitive Behavioral Therapy
- Keywords
- Post-traumatic Stress Disorder, Acute Stress Disorder, Cognitive behavioral therapy, Secondary Prevention, Anxiety disorders, Service Delivery
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Acute, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Based Cognitive Behavioral TherapyOther
Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed. Receives: Other: Telephone Based Cognitive Behavioral Therapy |
| Waitlist control group | No intervention | Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of PTSD Symptoms
Clinician Administered PTSD Scale for DSM IV (CAPS IV) Score range 0-136 points Score above 40 indicate probable PTSD PTSD diagnosis inferred using DSM IV diagnostic criteria
Measured: Up to ten months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Disorder - Post-traumatic (Acute)Studies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aria Shalev, Hadassah Medical Organization
- Investigators
- Arieh Y Shalev, M.D., Principal investigator, Hadassah University Hospital, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889005
- Sponsor's protocol ID
- Shalev_Phone_2009
- Status last verified
- Feb 2018
- First submitted
- 26 Apr 2009
- Last updated
- 1 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT00889005
- Acronym / sponsor ID
- Shalev_Phone_2009
- Conditions
- Stress Disorder - Post-traumatic (Acute)
- Keywords
- Post-traumatic Stress Disorder, Acute Stress Disorder, Cognitive behavioral therapy, Secondary Prevention, Anxiety disorders, Service Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Posted 1 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled study comparing telephone-based cognitive behavioral therapy (CBT) for recent survivors of traumatic events with Acute Stress Disorder (ASD) or acute PTSD with a waitlist control group. Survivors with PTSD from both groups will receive face-to-face CBT one month from the traumatic event. The study's main hypothesis is that early telephone-based CBT will reduce the prevalence of PTSD three and eight months after the traumatic event.
Detailed description
Post-traumatic Stress Disorder (PTSD) is a prevalent and pervasive mental disorder. Studies have shown that there is a significant reluctance to use mental health services by trauma-exposed individuals at high risk for developing PTSD. Providing clinical services in combat or disaster zone might be difficult. Trauma-focused cognitive behavioral therapy (CBT) effectively reduces the prevalence of PTSD among recent survivors. Telephone based CBT was found to be effective in mood and anxiety disorders, but has not been tried in PTSD. Establishing the effectiveness of telephone based CBT has significant service delivery and public health implications. Preventing PTSD significantly reduces individuals' suffering and disability We will screen, by telephone, up to 1200 survivors of traumatic events, from a general hospital emergency department trauma registry list, randomize the first 240 with ASD or Acute PTSD to either early, telephone based cognitive behavioral therapy (ET_CBT) (n=120) or a no-treatment control condition (n=120). We will provide five sessions of ET-CBT to the former and compare the two groups three and eight months later.
Survivors from both groups who will continue to have PTSD at three months (after either treatment or waiting list), will receive 12 sessions of face-to-face, trauma focused CBT. A first phase of the study will consist of establishing the acceptance of ET-CBT and its main components (e.g., exposure to traumatic reminders) by survivors, and optimizing the protocol. It will involve 20 survivors and no randomization. Subsequent to that phase we will start recruiting for the main study. The study's main hypothesis is that early CBT will reduce the prevalence of PTSD three and eight months after the traumatic event.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Other: Telephone Based Cognitive Behavioral TherapyFive sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed. |
| Waitlist control group | No intervention | –Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults
- Exposure to psychologically traumatic events
- Diagnosis of Acute Stress Disorder or Post-traumatic Stress Disorder
- Up to four weeks after trauma exposure
Key exclusion criteria (4 listed)
- Chronic PTSD
- Past and present psychosis, bipolar disorder, opiate or stimulants use
- Medical or surgical condition that interfere with subjects ability to participate in the study or sign an informed consent
- Lack of fluency in the study's main language (Hebrew)
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 |
|---|---|---|
| Telephone Based Cognitive Behavioral TherapyFive biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment | Other | Cognitive Behavioral Therapy |
Primary outcome
Severity of PTSD Symptoms
Time frame: Up to ten months
Clinician Administered PTSD Scale for DSM IV (CAPS IV) Score range 0-136 points Score above 40 indicate probable PTSD PTSD diagnosis inferred using DSM IV diagnostic criteria
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Arieh Y Shalev, M.D. principal investigator
Hadassah University Hospital, Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Based Cognitive Behavioral Therapy in people with Stress Disorder - Post-traumatic (Acute), run by Hadassah Medical Organization 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Nov 2018. 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. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Severity of PTSD Symptoms (time frame: Up to ten 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 1 Nov 2018.