Clinical trial NCT01277354: Effectiveness of Cognitive Processing Therapy in Pregnant Women With a History of Pregnancy Loss/Complication
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Stress Disorders
Anxiety
Depression
Keywords: Cognitive Processing Therapy (CPT)
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: March of Dimes
First posted: 2011-01-14
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study will assess the effectiveness of cognitive processing therapy (CPT) or cognitive behavioral therapy (CBT) among women who are experiencing symptoms of post-traumatic stress disorder (PTSD) and/or anxiety relating to a previous pregnancy loss or complication. Lastly, this study includes an option to participate in a procedure whereas startle response will be measured using the eyeblink reflex twice during pregnancy and once in the postpartum period. Startle response is examined using a standard acoustic startle procedure whereby heart rate, skin temperature and eye blinking reflex are measured.

Eligibility criteria: 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 adjustment in current dose of psychotropic medication.

Primary outcomes:
measure: CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Cynthia Neill Epperson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forray A, Mayes LC, Magriples U, Epperson CN. Prevalence of post-traumatic stress disorder in pregnant women with prior pregnancy complications. J Matern Fetal Neonatal Med. 2009 Jun;22(6):522-7. doi: 10.1080/14767050902801686.