Trial Outcomes & Findings for Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy (NCT NCT00889005)
NCT ID: NCT00889005
Last Updated: 2018-11-01
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
139 participants
Primary outcome timeframe
Up to ten months
Results posted on
2018-11-01
Participant Flow
Participant milestones
| Measure |
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
|
Waitlist Control Group
Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
74
|
|
Overall Study
COMPLETED
|
57
|
72
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
Reasons for withdrawal
| Measure |
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
|
Waitlist Control Group
Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy
n=65 Participants
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
|
Waitlist Control Group
n=74 Participants
Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.83 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
37.95 years
STANDARD_DEVIATION 12.71 • n=7 Participants
|
37.89 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
35 participants
n=5 Participants
|
42 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
30 participants
n=5 Participants
|
32 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
65 participants
n=5 Participants
|
74 participants
n=7 Participants
|
139 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to ten monthsPopulation: Survivors of traumatic event with Acute PTSD symptoms one month after trauma exposure
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
Outcome measures
| Measure |
Cognitive Behavioral Therapy
n=56 Participants
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
|
Waitlist Control Group
n=73 Participants
Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.
|
|---|---|---|
|
Severity of PTSD Symptoms
|
43.4 CAPS total Score at treatment end
Interval 33.9 to 45.8
|
43.9 CAPS total Score at treatment end
Interval 41.3 to 51.6
|
Adverse Events
Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Arieh Y. Shalev, M.D.
New York Langone Medical Center Department of Psychiatry
Phone: 6467544782
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place