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

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Anxiety; Post-traumatic Stress Disorder; Stress Disorders
• Intervention / Treatment: Behavioral: Cognitive Processing Therapy; Behavioral: Waitlist Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive Processing Therapy; Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.	Behavioral: Cognitive Processing Therapy; CPT utilizes a combination of a) exposure therapy aimed at extinguishing fear and distress induced by memories and external cues associated with the trauma, and b) cognitive behavioral techniques that address faulty thinking patterns developed to promote a sense of control over possible future traumas, but that instead perpetuate PTSD symptoms. In CPT, exposure to the traumatic memory occurs through writing and reading for periods of time determined by the client and is confined to the week of the 4th and 5th sessions. These sessions are otherwise used to identify "stuck-points", i.e., distorted interpretations regarding the trauma and unrealistic beliefs regarding self and others.
Placebo Comparator: Waitlist; Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.	Behavioral: Waitlist Placebo; Behavioral ratings are conducted by a blind rater.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6	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.	6 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: March of Dimes
• Investigators: Principal Investigator: Cynthia Neill Epperson, M.D., University of Pennsylvania

Publications and helpful links

General Publications

• 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.

Helpful Links

• Program Website

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: November 29, 2010
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 14, 2011

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Cognitive Processing Therapy (CPT)
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 810277; March of Dimes Foundation (Other Grant/Funding Number: 12-FY07-679)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO