Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy
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 Disease | Intervention/Treatment | Phase |
---|---|---|
|
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
Arms and Interventions
Arm | Intervention/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
- 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
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
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hadassah University Hospital | Jerusalem | Israel | 91120 |
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.- Shalev_Phone_2009
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Cognitive Behavioral Therapy | Waitlist Control Group |
---|---|---|
Arm/Group Description | Five 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 assignment | Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed. |
Period Title: Overall Study | ||
STARTED | 65 | 74 |
COMPLETED | 57 | 72 |
NOT COMPLETED | 8 | 2 |
Baseline Characteristics
Arm/Group Title | Cognitive Behavioral Therapy | Waitlist Control Group | Total |
---|---|---|---|
Arm/Group Description | Five 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 assignment | Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed. | Total of all reporting groups |
Overall Participants | 65 | 74 | 139 |
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
Title | Severity of PTSD Symptoms |
---|---|
Description | 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 |
Time Frame | Up to ten months |
Outcome Measure Data
Analysis Population Description |
---|
Survivors of traumatic event with Acute PTSD symptoms one month after trauma exposure |
Arm/Group Title | Cognitive Behavioral Therapy | Waitlist Control Group |
---|---|---|
Arm/Group Description | Five 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 assignment | Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed. |
Measure Participants | 56 | 73 |
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 Hypothesis | p-Value | 0.927 |
Comments | ||
Method | ANOVA | |
Comments |
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Cognitive Behavioral Therapy | Waitlist Control Group | ||
Arm/Group Description | Five 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 assignment | Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed. | ||
All Cause Mortality |
||||
Cognitive Behavioral Therapy | Waitlist Control Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Cognitive Behavioral Therapy | Waitlist Control Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/65 (0%) | 0/74 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Cognitive Behavioral Therapy | Waitlist Control Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/65 (0%) | 0/74 (0%) |
Limitations/Caveats
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/Title | Arieh Y. Shalev, M.D. |
---|---|
Organization | New York Langone Medical Center Department of Psychiatry |
Phone | 6467544782 |
arieh.shalev@nyumc.org |
- Shalev_Phone_2009