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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01277354
Recruitment Status : Terminated (Loss of funding)
First Posted : January 14, 2011
Results First Posted : August 8, 2016
Last Update Posted : April 17, 2017
March of Dimes
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Stress Disorders Anxiety Depression Behavioral: Cognitive Processing Therapy Behavioral: Waitlist Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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.

Primary Outcome Measures :
  1. CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6 [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01277354

United States, Pennsylvania
Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
March of Dimes
Principal Investigator: Cynthia Neill Epperson, M.D. University of Pennsylvania

Additional Information:
Publications of Results:
Responsible Party: University of Pennsylvania Identifier: NCT01277354     History of Changes
Other Study ID Numbers: 810277
March of Dimes Foundation ( Other Grant/Funding Number: 12-FY07-679 )
First Posted: January 14, 2011    Key Record Dates
Results First Posted: August 8, 2016
Last Update Posted: April 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Pennsylvania:
Cognitive Processing Therapy (CPT)

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders