Trial Outcomes & Findings for Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder (NCT NCT00391430)
NCT ID: NCT00391430
Last Updated: 2021-07-21
Results Overview
Salivary cortisol levels (measured before, during, and after the fMRI)
TERMINATED
PHASE4
39 participants
Measured 3 days before and after treatment and 1 day during fMRI
2021-07-21
Participant Flow
Participant milestones
| Measure |
Sertraline
Participants will receive treatment with sertraline
Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks
|
Control
Participants assigned to the control condition will receive no treatment
|
Cognitive Behavioral Therapy
Participants will receive cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
0
|
31
|
|
Overall Study
COMPLETED
|
5
|
0
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
12
|
Reasons for withdrawal
| Measure |
Sertraline
Participants will receive treatment with sertraline
Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks
|
Control
Participants assigned to the control condition will receive no treatment
|
Cognitive Behavioral Therapy
Participants will receive cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
12
|
Baseline Characteristics
Study was terminated due to poor enrollment. Data collected insufficient to conduct meaningful analyses.
Baseline characteristics by cohort
| Measure |
Control
Participants assigned to the control condition will receive no treatment
|
Sertraline
n=8 Participants
Participants will receive treatment with sertraline
Sertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks
|
Cognitive Behavioral Therapy
n=31 Participants
Participants will receive cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Female
|
0 Participants
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
|
0 Participants
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
|
0 Participants
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
|
0 Participants
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
|
|
Sex: Female, Male
Male
|
0 Participants
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
|
0 Participants
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
|
0 Participants
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
|
0 Participants
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
|
PRIMARY outcome
Timeframe: Measured 3 days before and after treatment and 1 day during fMRIPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Salivary cortisol levels (measured before, during, and after the fMRI)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Measured on 1 day during two MRIsPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 30 minutes before and after treatmentPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Assesses the full range of traumatic stressor over lifetime
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 30 minutes before and after treatmentPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Assesses severity and frequency of PTSD symptoms and provides information for diagnosis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 1 hour before and after treatmentPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Provides assessment of all anxiety and mood disorder diagnoses
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 15 minutes before and after treatmentPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
measure of frequency and severity of panic attacks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured weekly throughout the studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Assesses functional status of individual
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured weekly throughout the studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Assesses improvement in functioning
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at baselinePopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
social and demographic characteristics of the individual
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 10 minutes, before, during, and after treatmentPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
assesses worry and rumination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 10 times throughout studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
self-report measure of PTSD symptoms
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 10 times throughout studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
assesses a wide range of symptoms regarding the distress they cause
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 3 times throughout studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
assesses ability to regulate mood states
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 10 times throughout studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
assess experience of anger as both a state and trait like phenomenon
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 2 times throughout studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
assesses difficulty in identifying and naming feelings
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 10 times throughout studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
assesses types and severity of anxiety
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 3 times throughout studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
assesses type and severity of depression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 2 times throughout studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
assesses type and severity of interpersonal problems
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 2 times throughout studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
assesses social adjustment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 2 times throughout studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
review safety information related to fMRI procedure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured throughout studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
assessment of medical problems in past 12 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured throughout studyPopulation: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
assessment of type and frequency of use of medical services
Outcome measures
Outcome data not reported
Adverse Events
Sertraline
Control
Cognitive Behavioral Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place