Trial Outcomes & Findings for Treatment for Veterans With Military Sexual Trauma (NCT NCT00371644)
NCT ID: NCT00371644
Last Updated: 2015-01-15
Results Overview
The PCL is a 17-item self-report measure that is commonly used in clinical and research settings. All 17 items are summed to compute a total score of PTSD symptomatology. Scores for the PCL range from 17-85, with 85 indicating severe PTSD symptomatology. The PCL has strong psychometric properties and mirrors the symptomatology of the DSM.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
129 participants
Primary outcome timeframe
Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment
Results posted on
2015-01-15
Participant Flow
Participant milestones
| Measure |
Cognitive Processing Therapy (CPT)
Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).
Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape.
|
Present Centered Therapy (PCT)
Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).
Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
57
|
|
Overall Study
COMPLETED
|
44
|
44
|
|
Overall Study
NOT COMPLETED
|
28
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment for Veterans With Military Sexual Trauma
Baseline characteristics by cohort
| Measure |
Arm 1
n=52 Participants
Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).
Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape.
|
Arm 2
n=34 Participants
Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).
Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
48.4 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
46.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
34 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
PTSD Checklist
|
65.96 units on a scale
STANDARD_DEVIATION 10.63 • n=5 Participants
|
65.21 units on a scale
STANDARD_DEVIATION 13.25 • n=7 Participants
|
65.65 units on a scale
STANDARD_DEVIATION 11.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatmentPopulation: Numbers differ from enrollment due to participants excluded from data analysis for poor psychotherapeutic fidelity.
The PCL is a 17-item self-report measure that is commonly used in clinical and research settings. All 17 items are summed to compute a total score of PTSD symptomatology. Scores for the PCL range from 17-85, with 85 indicating severe PTSD symptomatology. The PCL has strong psychometric properties and mirrors the symptomatology of the DSM.
Outcome measures
| Measure |
Cognitive Processing Therapy (CPT)
n=52 Participants
Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).
Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape.
|
Present Centered Therapy (PCT)
n=34 Participants
Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).
Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD.
|
|---|---|---|
|
PTSD Checklist (PCL)
6-month follow-up
|
50.52 units on a scale
Standard Error 1.97
|
56.22 units on a scale
Standard Error 2.17
|
|
PTSD Checklist (PCL)
Baseline
|
65.53 units on a scale
Standard Error 1.67
|
65.40 units on a scale
Standard Error 2.00
|
|
PTSD Checklist (PCL)
Posttreatment (12 Sessions)
|
51.39 units on a scale
Standard Error 2.02
|
57.89 units on a scale
Standard Error 2.18
|
|
PTSD Checklist (PCL)
2-month follow-up
|
52.71 units on a scale
Standard Error 1.98
|
59.35 units on a scale
Standard Error 2.24
|
|
PTSD Checklist (PCL)
4-month follow-up
|
54.98 units on a scale
Standard Error 1.99
|
55.22 units on a scale
Standard Error 2.15
|
Adverse Events
Arm 1
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=72 participants at risk
Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).
Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape.
|
Arm 2
n=57 participants at risk
Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).
Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
4.2%
3/72 • Number of events 3
|
3.5%
2/57 • Number of events 2
|
|
Psychiatric disorders
Hospitalization
|
6.9%
5/72 • Number of events 5
|
5.3%
3/57 • Number of events 3
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place