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| ID | Type | Description | Link |
|---|---|---|---|
| MH- |
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To prospectively evaluate the effect of early treatment (cognitive therapy (CT), cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of post-traumatic stress disorder in recent survivors of traumatic events.
Consecutive civilian trauma survivors will be contacted, by phone, within five days of admission to Hadassah University Hospital in Jerusalem and asked about their early psychological responses to the event. A short telephone interview will be administered to consenting subjects, to evaluate the presence of acute stress disorder (ASD). Subjects with ASD (full or partial) and those who so desire will be invited to clinical assessment, which will take place within the next two weeks. Survivors with significant symptoms of post-traumatic stress disorder will be randomized to five arms of twelve-week long treatment: CBT, CT, SSRI/placebo and waiting list (WL) and start treatment immediately. Subjects will be allowed to decline one form of therapy. WL subjects will start therapy 12 weeks later. All subjects who had clinical interview will be interviewed again at four and seven months - and 14 months following trauma (phone interview).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Exposure (CBT) | Experimental | Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy |
|
| Cognitive Therapy | Active Comparator | Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders. |
|
| SSRI (escitalopram) | Experimental | Twenty milligrams daily of escitalopram (blinded capsules) |
|
| Placebo | Placebo Comparator | Two concealed placebo pills resembling 10mg escitalopram tablets |
|
| Waiting List | No Intervention | Twelve weeks of waiting list no intervention group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Procedure | 12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-traumatic Stress Disorder (chronic) by CAPS scores. | Four months, seven months, 14 moths, two years |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview) | Four months, seven months, 14 moths, two years | |
| Symptoms of depression as per the Beck Depression Inventory (BDI) | Four months, seven months, 14 moths, two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arieh Y Shalev, M.D. | Hadassah Medical Organization | Principal Investigator |
| Yossi Israeli - Shalev, M.A. | Hadassah Medical Organization | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization Jerusalem Israel | Jerusalem | 91120 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21724790 | Result | Shalev AY, Ankri YL, Peleg T, Israeli-Shalev Y, Freedman S. Barriers to receiving early care for PTSD: results from the Jerusalem trauma outreach and prevention study. Psychiatr Serv. 2011 Jul;62(7):765-73. doi: 10.1176/ps.62.7.pss6207_0765. | |
| 21969418 | Result | Shalev AY, Ankri Y, Israeli-Shalev Y, Peleg T, Adessky R, Freedman S. Prevention of posttraumatic stress disorder by early treatment: results from the Jerusalem Trauma Outreach And Prevention study. Arch Gen Psychiatry. 2012 Feb;69(2):166-76. doi: 10.1001/archgenpsychiatry.2011.127. Epub 2011 Oct 3. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D011437 | Propylamines |
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| Cognitive Therapy | Procedure | 12 weekly 1.5 hours weekly session of cognitive therapy without exposure |
|
| Escitalopram | Drug | Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg |
|
|
| Placebo | Other | Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance |
|
| 38767196 | Derived | Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2. |
| 35141873 | Derived | Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2. |
| 32122334 | Derived | van der Mei WF, Barbano AC, Ratanatharathorn A, Bryant RA, Delahanty DL, deRoon-Cassini TA, Lai BS, Lowe SR, Matsuoka YJ, Olff M, Qi W, Schnyder U, Seedat S, Kessler RC, Koenen KC, Shalev AY; International Consortium to Predict PTSD. Evaluating a screener to quantify PTSD risk using emergency care information: a proof of concept study. BMC Emerg Med. 2020 Mar 2;20(1):16. doi: 10.1186/s12873-020-00308-z. |
| 27135249 | Derived | Shalev AY, Ankri Y, Gilad M, Israeli-Shalev Y, Adessky R, Qian M, Freedman S. Long-term outcome of early interventions to prevent posttraumatic stress disorder. J Clin Psychiatry. 2016 May;77(5):e580-7. doi: 10.4088/JCP.15m09932. |
| D000588 |
| Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |