Effectiveness of Cognitive Processing Therapy in Pregnant Women With a History of Pregnancy Loss/Complication
Stopped early · Not applicable · Has a placebo group
Conditions studied: Post-traumatic Stress Disorder, Stress Disorders, Anxiety, Depression
In brief
The purpose of this study is to examine the effects of experiencing a previous pregnancy loss or complication on current physiological and emotional aspects of a current pregnancy.
Key facts
- Study ID
- NCT01277354
- Run by
- University of Pennsylvania
- People needed
- 2
- Starts
- 2010-04-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2017-04-17
Who can join
Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Meet DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for full PTSD or partial PTSD.
- Clinician Administered PTSD Scale (CAPS) score of ≥18.
- Gestational age at the time of presentation is between 8 and 30 weeks.
- History of at least one of the following: previous pregnancy loss or losses, voluntary termination due to fetal anomaly, obstetrical complication including childbirth, premature birth (<32 weeks), unexpected neonatal complication, emergency C-section, neonatal death within 28 days of delivery.
- Fluency in spoken and written English.
You may not qualify if…
- Presence of any lifetime or comorbid DSM-IV Axis I psychotic disorder (including bipolar disorder and MDD (Major Depressive Disorder) with psychotic features and excepting Psychosis NOS (Not Otherwise Specified) related to sensory hallucinations, i.e. reexperiencing symptoms).
- Presence of any comorbid Axis I or Axis II (as determined using the SCID-II (Structured Clinical Interview for DSM-IV)) disorder, which would require immediate treatment or renders the subject clinically unsuitable for this RTC (randomized clinical trial).
- History of PTSD due to a NON-Pregnancy related traumatic event.
- Presence of a known abnormality in the present fetus.
- Presence of a serious medical or neurological illness.
- Starting a new psychotropic agent within the previous 3 months.
- Assessed to require a new psychotropic medication at the screening appointment or an adjustment in current dose of psychotropic medication.
Where it is running
- Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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