Stress Disorder - Post-traumatic (Acute)
Conditions
Keywords
Post-traumatic Stress Disorder, Acute Stress Disorder, Cognitive behavioral therapy, Secondary Prevention, Anxiety disorders, Service Delivery
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.
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.
Interventions
Five biweekly sessions of telephone based, trauma focused cognitive behavioral therapy with homework assignment
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Behavioral Therapy 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 | 65 |
| Waitlist Control Group Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed. | 74 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Therapy | Total | Waitlist Control Group |
|---|---|---|---|
| Age, Continuous | 37.83 years STANDARD_DEVIATION 12.2 | 37.89 years STANDARD_DEVIATION 10.4 | 37.95 years STANDARD_DEVIATION 12.71 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 65 Participants | 139 Participants | 74 Participants |
| Region of Enrollment Israel | 65 participants | 139 participants | 74 participants |
| Sex/Gender, Customized Female | 35 participants | 77 participants | 42 participants |
| Sex/Gender, Customized Male | 30 participants | 62 participants | 32 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 65 | 0 / 74 |
| serious Total, serious adverse events | 0 / 65 | 0 / 74 |
Outcome results
Primary
Severity of PTSD Symptoms
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
Population: Survivors of traumatic event with Acute PTSD symptoms one month after trauma exposure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cognitive Behavioral Therapy | Severity of PTSD Symptoms | 43.4 CAPS total Score at treatment end |
| Waitlist Control Group | Severity of PTSD Symptoms | 43.9 CAPS total Score at treatment end |
p-value: 0.927ANOVA