Trial Outcomes & Findings for Neuroimaging the Impact of Treatment on Neural Substrates of Trust in Post-Traumatic Stress Disorder (PTSD) (NCT NCT01244477)
NCT ID: NCT01244477
Last Updated: 2019-06-27
Results Overview
COMPLETED
NA
61 participants
Pre & post a 12 week treatment group
2019-06-27
Participant Flow
Participant milestones
| Measure |
CPT-C
Group Cognitive Processing Therapy-C (CPT-C): Participants who chose to participate in a 12-week CPT-C treatment group.
|
Treatment-as-Usual
Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
23
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
20
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuroimaging the Impact of Treatment on Neural Substrates of Trust in Post-Traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
CPT-C
n=38 Participants
Participants in group CPT-C
Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks.
|
Treatment-as-Usual
n=23 Participants
Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
38 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
13 participants
n=5 Participants
|
5 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian or White
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre & post a 12 week treatment groupPopulation: Neural data is not analyzable - scanner technicians changed the parameters of the task fMRI on an unpredictable basis. Project staff and data no longer available.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Pre & post a 12 week treatment groupPopulation: We limited this arm to 18 subjects who completed 9+ out of 12 treatment sessions.
The CAPS is considered the gold standard measure of PTSD symptoms. CAPS scores are the sum of 17 questions. Each is question is scored from 0 (best possible outcome) to 8 (worst possible outcome). The lowest possible CAPS score is a 0, indicating no PTSD symptoms reported. The highest possible CAPS score is a 136, indicating the most PTSD symptoms reported.
Outcome measures
| Measure |
Arm 1: CPT-C Group
n=18 Participants
Participants in group CPT-C
Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks.
|
Arm 2: Waitlist Control Group
n=20 Participants
Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
|
|---|---|---|
|
The Clinician Administered PTSD Scale (CAPS)
Pre-Therapy or before 12 weeks
|
79.3 CAPS Scores
Standard Deviation 18.6
|
66.3 CAPS Scores
Standard Deviation 26.2
|
|
The Clinician Administered PTSD Scale (CAPS)
Post-Therapy or after 12 weeks
|
70.3 CAPS Scores
Standard Deviation 24.1
|
69.5 CAPS Scores
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: Pre & post a 12 week treatment groupPopulation: Veterans with PTSD under 50 years of age
The Investment Ratio (IR) is the amount subjects were willing to invest in a social partner. It is considered a measure of interpersonal trust, and co-operation. It is a ratio ranging from 0 (indicating no willingness to trust a social partner) to 1.0 (willing to totally trust a social partner). It consists of the percentage of total points the subject was willing to invest in a social partner divided by the total points they received for all ten rounds of the trust game. Higher ratio's indicate more trust.
Outcome measures
| Measure |
Arm 1: CPT-C Group
n=18 Participants
Participants in group CPT-C
Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks.
|
Arm 2: Waitlist Control Group
n=20 Participants
Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
|
|---|---|---|
|
Behavioral Expression of Trust on the Trust Game
Pre-Treatment Investment Ratio
|
.31 Ratio
Standard Deviation .17
|
.34 Ratio
Standard Deviation .23
|
|
Behavioral Expression of Trust on the Trust Game
Post-Treatment Investment Ratio
|
.37 Ratio
Standard Deviation .27
|
.28 Ratio
Standard Deviation .25
|
SECONDARY outcome
Timeframe: Administered each week at weekly group sessions or pre-post treatment as usualPopulation: Veterans under 50 years of age diagnosed with PTSD
An instrument measuring a participants self-reported level of PTSD symptoms. PCL scores are the sum of 17 questions. Each is question is scored from 1 (best possible outcome) to 5 (worst possible outcome). The lowest possible PCL score is a 17, indicating no troublesome PTSD symptoms reported. The highest possible PCL score is a 85, indicating the worst degree of PTSD symptoms reported.
Outcome measures
| Measure |
Arm 1: CPT-C Group
n=18 Participants
Participants in group CPT-C
Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks.
|
Arm 2: Waitlist Control Group
n=19 Participants
Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
|
|---|---|---|
|
PTSD Checklist (PCL)
Pre-Treatment PCL-M Scores
|
65.33 PCL Scores
Standard Deviation 11.0
|
56.83 PCL Scores
Standard Deviation 17.1
|
|
PTSD Checklist (PCL)
Post-Treatment PCL-M Scores
|
58.37 PCL Scores
Standard Deviation 13.48
|
59.53 PCL Scores
Standard Deviation 11.88
|
Adverse Events
CPT-C
Treatment-as-Usual
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