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

Not Applicable

Terminated

• Conditions: Depression; Stress Disorders; Post-traumatic Stress Disorder; Anxiety
• Interventions: Behavioral: Cognitive Processing Therapy; Behavioral: Waitlist Placebo

• Registration Number: NCT01277354
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-14
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2015-09-28
• Results First Submitted QC: 2016-06-24
• Results First Posted: 2016-08-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Processing Therapy	Cognitive Processing Therapy	Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
Waitlist	Waitlist Placebo	Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.

Primary Outcome Measures

Name	Time	Method
CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6	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.

Trial Locations

Locations (1)

Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States