Effectiveness of Cognitive Processing Therapy in Pregnant Women With a History of Pregnancy Loss/Complication
|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
|Condition or disease||Intervention/treatment||Phase|
|Post-traumatic Stress Disorder Stress Disorders Anxiety Depression||Behavioral: Cognitive Processing Therapy Behavioral: Waitlist Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effectiveness of Cognitive Processing Therapy in Reducing Post-traumatic Symptoms and Enhancing Birth Outcomes in Pregnant Women With a Previous Pregnancy Loss or Complication|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Active Comparator: Cognitive Processing Therapy
Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
Behavioral: Cognitive Processing Therapy
CPT utilizes a combination of a) exposure therapy aimed at extinguishing fear and distress induced by memories and external cues associated with the trauma, and b) cognitive behavioral techniques that address faulty thinking patterns developed to promote a sense of control over possible future traumas, but that instead perpetuate PTSD symptoms. In CPT, exposure to the traumatic memory occurs through writing and reading for periods of time determined by the client and is confined to the week of the 4th and 5th sessions. These sessions are otherwise used to identify "stuck-points", i.e., distorted interpretations regarding the trauma and unrealistic beliefs regarding self and others.
Placebo Comparator: Waitlist
Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
Behavioral: Waitlist Placebo
Behavioral ratings are conducted by a blind rater.
- CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6 [ Time Frame: 6 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277354
|United States, Pennsylvania|
|Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Cynthia Neill Epperson, M.D.||University of Pennsylvania|