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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

November 29, 2010
December 9, 2011
April 2010
June 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01277354 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Post-traumatic Stress Disorder
  • Stress Disorders
  • Anxiety
  • Depression
  • 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.
  • Behavioral: Waitlist Placebo
    Behavioral ratings are conducted by a blind rater.
  • Active Comparator: CPT
    Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
    Intervention: Behavioral: Cognitive Processing Therapy
  • Placebo Comparator: Waitlist
    Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
    Intervention: Behavioral: Waitlist Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01277354
810277, March of Dimes Foundation
No
C. Neill Epperson, M.D., Associate Professor of Psychiatry, and Obstetrics & Gynecology, University of Pennsylvania School of Medicine
University of Pennsylvania
March of Dimes
Principal Investigator: C. Neill Epperson, M.D. University of Pennsylvania
University of Pennsylvania
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP