Effectiveness of Cognitive Processing Therapy in Pregnant Women With a History of Pregnancy Loss/… (NCT01277354) | Clinical Trial Compass
TerminatedNot Applicable
Effectiveness of Cognitive Processing Therapy in Pregnant Women With a History of Pregnancy Loss/Complication
Stopped: Loss of funding
United States2 participantsStarted 2010-04
Plain-language summary
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.
Who can participate
Age range18 Years – 49 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 adjustm…
What they're measuring
1
CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6