Trial Outcomes & Findings for Comparison of Two Treatments for Post-Traumatic Stress Disorder (NCT NCT00127673)
NCT ID: NCT00127673
Last Updated: 2022-05-24
Results Overview
total score, range from 0-80, higher scores are more severe
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
Post-treatment, ten weeks
Results posted on
2022-05-24
Participant Flow
Participant milestones
| Measure |
NoChoice_CBT
Participants will receive no choice cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
Choice_CBT
Participants will receive choice cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
NoChoice_SER
Participants will receive no choice sertraline
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
Choice_SER
Participants will receive choice sertraline
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
61
|
55
|
36
|
|
Overall Study
COMPLETED
|
23
|
44
|
35
|
25
|
|
Overall Study
NOT COMPLETED
|
25
|
17
|
20
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Treatments for Post-Traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
NoChoice_CBT
n=48 Participants
Participants will receive no choice cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
Choice_CBT
n=61 Participants
Participants will receive choice cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
NoChoice_SER
n=55 Participants
Participants will receive no choice sertraline
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
Choice_SER
n=36 Participants
Participants will receive choice sertraline
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
36.60 years
STANDARD_DEVIATION 11.30 • n=21 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
152 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
190 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Post-treatment, ten weekstotal score, range from 0-80, higher scores are more severe
Outcome measures
| Measure |
CBT no Choice
n=42 Participants
Participants will receive no choice cognitive behavioral therapy (CBT no choice)
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
CBT Choice
n=53 Participants
Participants will receive choice cognitive behavioral therapy (CBT choice)
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
Sertraline no Choice
n=33 Participants
Participants will receive no choice sertraline (sertraline no choice)
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
Sertraline Choice
n=27 Participants
Participants will receive choice sertraline (sertraline choice)
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
|---|---|---|---|---|
|
PTSD Symptoms
|
10.02 units on a scale
Standard Deviation 10.27
|
10.87 units on a scale
Standard Deviation 8.75
|
15.12 units on a scale
Standard Deviation 14.03
|
10.78 units on a scale
Standard Deviation 7.59
|
PRIMARY outcome
Timeframe: Measured at Post-Treatment, at 10 weeksHamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression
Outcome measures
| Measure |
CBT no Choice
n=42 Participants
Participants will receive no choice cognitive behavioral therapy (CBT no choice)
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
CBT Choice
n=53 Participants
Participants will receive choice cognitive behavioral therapy (CBT choice)
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
Sertraline no Choice
n=33 Participants
Participants will receive no choice sertraline (sertraline no choice)
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
Sertraline Choice
n=27 Participants
Participants will receive choice sertraline (sertraline choice)
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
|---|---|---|---|---|
|
Depression Symptoms
|
10.33 units on a scale
Standard Deviation 10.33
|
12.13 units on a scale
Standard Deviation 8.67
|
15.24 units on a scale
Standard Deviation 13.90
|
12.11 units on a scale
Standard Deviation 10.12
|
PRIMARY outcome
Timeframe: Measured at Post-Treatment, at 10 weeksPopulation: Completer analysis
State-Trait Anxiety Inventory - State version, total score, scoring range, 0-63, with higher scores more severe
Outcome measures
| Measure |
CBT no Choice
n=42 Participants
Participants will receive no choice cognitive behavioral therapy (CBT no choice)
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
CBT Choice
n=53 Participants
Participants will receive choice cognitive behavioral therapy (CBT choice)
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
Sertraline no Choice
n=33 Participants
Participants will receive no choice sertraline (sertraline no choice)
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
Sertraline Choice
n=27 Participants
Participants will receive choice sertraline (sertraline choice)
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
|---|---|---|---|---|
|
State Anxiety
|
39.16 units on a scale
Standard Deviation 13.83
|
38.79 units on a scale
Standard Deviation 13.13
|
46.89 units on a scale
Standard Deviation 18.91
|
38.72 units on a scale
Standard Deviation 12.48
|
SECONDARY outcome
Timeframe: Measured at Post-Treatment, at 10 weeksSheehan Disability Scale (SDS), total score, scoring range 0-30 , higher scores indicative of worse functional impairment
Outcome measures
| Measure |
CBT no Choice
n=42 Participants
Participants will receive no choice cognitive behavioral therapy (CBT no choice)
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
CBT Choice
n=53 Participants
Participants will receive choice cognitive behavioral therapy (CBT choice)
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
Sertraline no Choice
n=33 Participants
Participants will receive no choice sertraline (sertraline no choice)
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
Sertraline Choice
n=27 Participants
Participants will receive choice sertraline (sertraline choice)
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
|---|---|---|---|---|
|
Quality of Life Functioning
|
8.82 units on a scale
Standard Deviation 6.24
|
11.68 units on a scale
Standard Deviation 8.23
|
14.06 units on a scale
Standard Deviation 10.38
|
10.78 units on a scale
Standard Deviation 9.40
|
Adverse Events
NoChoice_CBT
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Choice_CBT
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
NoChoice_SER
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Choice_SER
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NoChoice_CBT
n=48 participants at risk
Participants will receive no choice cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
Choice_CBT
n=61 participants at risk
Participants will receive choice cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
NoChoice_SER
n=55 participants at risk
Participants will receive no choice sertraline
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
Choice_SER
n=36 participants at risk
Participants will receive choice sertraline
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chest pain/shortness of breath
|
2.1%
1/48 • Number of events 1 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/61 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/55 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/36 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
|
Surgical and medical procedures
Kidney Stones
|
0.00%
0/48 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
1.6%
1/61 • Number of events 1 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/55 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/36 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
0.00%
0/48 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
1.6%
1/61 • Number of events 1 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/55 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/36 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
Other adverse events
| Measure |
NoChoice_CBT
n=48 participants at risk
Participants will receive no choice cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
Choice_CBT
n=61 participants at risk
Participants will receive choice cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
|
NoChoice_SER
n=55 participants at risk
Participants will receive no choice sertraline
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
Choice_SER
n=36 participants at risk
Participants will receive choice sertraline
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal discomfort
|
0.00%
0/48 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/61 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
3.6%
2/55 • Number of events 2 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
5.6%
2/36 • Number of events 3 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
|
Reproductive system and breast disorders
Delayed ejaculation
|
0.00%
0/48 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/61 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/55 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
2.8%
1/36 • Number of events 1 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
|
Renal and urinary disorders
Urinary hesitancy
|
0.00%
0/48 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/61 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
1.8%
1/55 • Number of events 1 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/36 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
|
Injury, poisoning and procedural complications
Hospital admission after accident
|
0.00%
0/48 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
1.6%
1/61 • Number of events 1 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/55 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/36 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
|
Infections and infestations
Viral tonsilitis
|
0.00%
0/48 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
1.6%
1/61 • Number of events 1 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/55 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/36 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
|
Psychiatric disorders
Transient increased in agitation/anxiety
|
4.2%
2/48 • Number of events 2 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
1.6%
1/61 • Number of events 1 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/55 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/36 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
|
Nervous system disorders
Headache/dizziness
|
0.00%
0/48 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
0.00%
0/61 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
1.8%
1/55 • Number of events 1 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
5.6%
2/36 • Number of events 6 • Approximately 4 months
After randomization through acute treatment until post-treatment assessment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place