Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Completed
CT.gov ID
NCT00889005
Collaborator
(none)
139
Enrollment
1
Location
2
Arms
43
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Telephone Based Cognitive Behavioral Therapy
N/A

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

Study Type:
Interventional
Actual Enrollment :
139 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

ArmIntervention/Treatment
Experimental: Cognitive Behavioral Therapy

Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.

Other: Telephone Based Cognitive Behavioral Therapy
Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment

No Intervention: Waitlist control group

Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.

Outcome Measures

Primary Outcome Measures

  1. Severity of PTSD Symptoms [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Hadassah University HospitalJerusalemIsrael91120

Sponsors and Collaborators

  • Hadassah Medical Organization

Investigators

  • Principal Investigator: Arieh Y Shalev, M.D., Hadassah University Hospital, Jerusalem

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aria Shalev, Professor of Psychiatry, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00889005
Other Study ID Numbers:
  • Shalev_Phone_2009
First Posted:
Apr 28, 2009
Last Update Posted:
Nov 1, 2018
Last Verified:
Feb 1, 2018

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleCognitive Behavioral TherapyWaitlist Control Group
Arm/Group DescriptionFive sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed. Telephone Based Cognitive Behavioral Therapy: Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignmentFive weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
Period Title: Overall Study
STARTED6574
COMPLETED5772
NOT COMPLETED82

Baseline Characteristics

Arm/Group TitleCognitive Behavioral TherapyWaitlist Control GroupTotal
Arm/Group DescriptionFive sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed. Telephone Based Cognitive Behavioral Therapy: Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignmentFive weeks without active intervention, followed by assessment and referral to clinical treatment if needed.Total of all reporting groups
Overall Participants6574139
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
37.83
(12.2)
37.95
(12.71)
37.89
(10.4)
Sex/Gender, Customized (participants) [Number]
Female
35
53.8%
42
56.8%
77
55.4%
Male
30
46.2%
32
43.2%
62
44.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
0
0%
0
0%
0
0%
White
65
100%
74
100%
139
100%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
Israel
65
100%
74
100%
139
100%

Outcome Measures

1. Primary Outcome
TitleSeverity of PTSD Symptoms
DescriptionClinician 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
Time FrameUp to ten months

Outcome Measure Data

Analysis Population Description
Survivors of traumatic event with Acute PTSD symptoms one month after trauma exposure
Arm/Group TitleCognitive Behavioral TherapyWaitlist Control Group
Arm/Group DescriptionFive sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed. Telephone Based Cognitive Behavioral Therapy: Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignmentFive weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
Measure Participants5673
Mean (95% Confidence Interval) [CAPS total Score at treatment end]
43.4
43.9
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Behavioral Therapy, Waitlist Control Group
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.927
Comments
MethodANOVA
Comments

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleCognitive Behavioral TherapyWaitlist Control Group
Arm/Group DescriptionFive sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed. Telephone Based Cognitive Behavioral Therapy: Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignmentFive weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
All Cause Mortality
Cognitive Behavioral TherapyWaitlist Control Group
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
Cognitive Behavioral TherapyWaitlist Control Group
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/65 (0%) 0/74 (0%)
Other (Not Including Serious) Adverse Events
Cognitive Behavioral TherapyWaitlist Control Group
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/65 (0%) 0/74 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleArieh Y. Shalev, M.D.
OrganizationNew York Langone Medical Center Department of Psychiatry
Phone6467544782
Emailarieh.shalev@nyumc.org
Responsible Party:
Aria Shalev, Professor of Psychiatry, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00889005
Other Study ID Numbers:
  • Shalev_Phone_2009
First Posted:
Apr 28, 2009
Last Update Posted:
Nov 1, 2018
Last Verified:
Feb 1, 2018