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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277354
• Other study ID #: 810277
• Secondary ID: March of Dimes F
• Status: Completed
• Phase: N/A
• First received: November 29, 2010
• Last updated: December 9, 2011
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2011
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Disease
• Post-traumatic Stress Disorder
• Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• Waitlist Placebo
Behavioral ratings are conducted by a blind rater.

Locations

Country	Name	City	State
United States	Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania
United States	Penn Ob/Gyn Associates (3701 Market Street)	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital (801 Spruce Street)	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	March of Dimes

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS)	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	No

External Links

•   Program Website