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Effectiveness of Cognitive Processing Therapy in Pregnant Women With a History of Pregnancy Loss/Complication | Clinical Trials | Clareo Health

TERMINATEDNA

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

Effectiveness of Cognitive Processing Therapy in Reducing Post-traumatic Symptoms and Enhancing Birth Outcomes in Pregnant Women With a Previous Pregnancy Loss or Complication

NCT01277354•University of Pennsylvania

View on ClinicalTrials.gov

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

Age

18 - 49 years

Sex

FEMALE

Healthy Volunteers

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.

Locations (1)

Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 1, 2010

Primary Completion Date

June 1, 2011

Completion Date

June 1, 2011

Last Updated

April 17, 2017

Enrollment

ACTUAL participants

Conditions

Post-traumatic Stress DisorderStress DisordersAnxietyDepression

Interventions

Cognitive Processing Therapy

BEHAVIORAL

Waitlist Placebo

BEHAVIORAL

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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