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Effectiveness of Cognitive Processing Therapy in Pregnant Women With a History of Pregnancy Loss/Complication

This study has been terminated.
(The limitations of this trial include an insufficient number of subjects enrolled which prohibits our ability to analyze the data in any meaningful fashion.)
Sponsor:
Collaborator:
March of Dimes
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01277354
First received: November 29, 2010
Last updated: June 24, 2016
Last verified: June 2016
Results First Received: September 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Post-traumatic Stress Disorder
Stress Disorders
Anxiety
Depression
Interventions: Behavioral: Cognitive Processing Therapy
Behavioral: Waitlist Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment for this project was slow and only two subjects matriculated during the period that this project was active.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    CPT Group     Waitlist Group  
STARTED     1     1  
COMPLETED     1     1  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    CPT Group     Waitlist Group     Total  
Number of Participants  
[units: participants]
  1     1     2  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     1     2  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     1     2  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     1     1     2  



  Outcome Measures

1.  Primary:   Clinician Administered PTSD Scale (CAPS)   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The limitations of this trial include an insufficient number of subjects enrolled which prohibits our ability to analyze the data in any meaningful fashion.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. C. Neill Epperson
Organization: University of Pennsylvania
phone: 215-573-8871
e-mail: cepp@mail.med.upenn.edu


Publications of Results:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01277354     History of Changes
Other Study ID Numbers: 810277
March of Dimes Foundation ( Other Grant/Funding Number: 12-FY07-679 )
Study First Received: November 29, 2010
Results First Received: September 28, 2015
Last Updated: June 24, 2016
Health Authority: United States: Institutional Review Board