Clinical trial NCT00146900: Prevention of Post Traumatic Stress Disorder by Early Treatment
Official title: Prevention of Post Traumatic Stress Disorder by Early Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: Traumatic Events
Post-traumatic Stress Disorder
Treatment (psychological)
Treatment (pharmacological)
Prevention
SSRIs
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-07
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Adults survivors of traumatic events

Exclusion Criteria:

* Traumatic brain injury
* Lifetime psychosis
* Life time (prior) PTSD
* Medical conditions forbidding SSRIs

Primary outcomes:
measure: Post-traumatic Stress Disorder (chronic) by CAPS scores.
timeFrame: Four months, seven months, 14 moths, two years
Secondary outcomes:
measure: Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview)
timeFrame: Four months, seven months, 14 moths, two years
measure: Symptoms of depression as per the Beck Depression Inventory (BDI)
timeFrame: Four months, seven months, 14 moths, two years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization Jerusalem Israel
Study officials:
affiliation: Hadassah Medical Organization
name: Arieh Y Shalev, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Yossi Israeli - Shalev, M.A.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.