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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01277354
Recruitment Status : Terminated (Loss of funding)
First Posted : January 14, 2011
Results First Posted : August 8, 2016
Last Update Posted : April 17, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Post-traumatic Stress Disorder
Stress Disorders
Anxiety
Depression
Interventions: Behavioral: Cognitive Processing Therapy
Behavioral: Waitlist Placebo

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 1   1   2 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      1 100.0%      1 100.0%      2 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1 100.0%      1 100.0%      2 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   1   1   2 


  Outcome Measures

1.  Primary:   CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Cynthia Neill Epperson, M.D.
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 )
First Submitted: November 29, 2010
First Posted: January 14, 2011
Results First Submitted: September 28, 2015
Results First Posted: August 8, 2016
Last Update Posted: April 17, 2017