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

This study has been completed.
Sponsor:
Collaborator:
March of Dimes
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01277354
First received: November 29, 2010
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

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 Intervention
Post-traumatic Stress Disorder
Stress Disorders
Anxiety
Depression
Behavioral: Cognitive Processing Therapy
Behavioral: Waitlist Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 2
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CPT
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.

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

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277354

Locations
United States, Pennsylvania
Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital (801 Spruce Street)
Philadelphia, Pennsylvania, United States, 19107
Penn Ob/Gyn Associates (3701 Market Street)
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
March of Dimes
Investigators
Principal Investigator: C. Neill Epperson, M.D. University of Pennsylvania
  More Information

Additional Information:
Publications:
Responsible Party: C. Neill Epperson, M.D., Associate Professor of Psychiatry, and Obstetrics & Gynecology, University of Pennsylvania School of Medicine
ClinicalTrials.gov Identifier: NCT01277354     History of Changes
Other Study ID Numbers: 810277, March of Dimes Foundation
Study First Received: November 29, 2010
Last Updated: December 9, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014