Trial Outcomes & Findings for Effectiveness of Cognitive Processing Therapy in Pregnant Women With a History of Pregnancy Loss/Complication (NCT NCT01277354)
NCT ID: NCT01277354
Last Updated: 2017-04-17
Results Overview
The CAPS will be used in the diagnosis of PTSD, assessment of the impact of symptoms on function, assessment of the severity of symptoms at baseline, and weekly throughout the study. The CAPS in this particular study must decrease by 50% for CPT to be deemed effective.
TERMINATED
NA
2 participants
6 weeks
2017-04-17
Participant Flow
Recruitment for this project was slow and only two subjects matriculated during the period that this project was active.
Participant milestones
| Measure |
CPT Group
Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
|
Waitlist Group
Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Cognitive Processing Therapy in Pregnant Women With a History of Pregnancy Loss/Complication
Baseline characteristics by cohort
| Measure |
CPT Group
n=1 Participants
Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
|
Waitlist Group
n=1 Participants
Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Please note that there were only a total of 2 participants involved in this study. Funding was lost to continue and the study was terminated.
The CAPS will be used in the diagnosis of PTSD, assessment of the impact of symptoms on function, assessment of the severity of symptoms at baseline, and weekly throughout the study. The CAPS in this particular study must decrease by 50% for CPT to be deemed effective.
Outcome measures
| Measure |
CPT Group
n=1 Participants
Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
|
Waitlist Group
n=1 Participants
Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
|
|---|---|---|
|
CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6
|
1 Participants
|
1 Participants
|
Adverse Events
CPT Group
Waitlist Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cynthia Neill Epperson, M.D.
University of Pennsylvania
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place