- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00889005
Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Jerusalem, Israel, 91120
- Hadassah University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adults
- Exposure to psychologically traumatic events
- Diagnosis of Acute Stress Disorder or Post-traumatic Stress Disorder
- Up to four weeks after trauma exposure
Exclusion Criteria:
- 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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Cognitive Behavioral Therapy
Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.
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Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment
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Ingen indgriben: Waitlist control group
Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Severity of PTSD Symptoms
Tidsramme: Up to ten months
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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
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Up to ten months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Arieh Y Shalev, M.D., Hadassah University Hospital, Jerusalem
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Shalev_Phone_2009
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