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

Primary Purpose

Post-traumatic Stress Disorder, Stress Disorders, Anxiety

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy
Waitlist Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring Cognitive Processing Therapy (CPT)

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cognitive Processing Therapy

Waitlist

Arm Description

Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.

Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2010
Last Updated
March 20, 2017
Sponsor
University of Pennsylvania
Collaborators
March of Dimes
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1. Study Identification

Unique Protocol Identification Number
NCT01277354
Brief Title
Effectiveness of Cognitive Processing Therapy in Pregnant Women With a History of Pregnancy Loss/Complication
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Loss of funding
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
March of Dimes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder, Stress Disorders, Anxiety, Depression
Keywords
Cognitive Processing Therapy (CPT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Processing Therapy
Arm Type
Active Comparator
Arm Description
Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
Arm Title
Waitlist
Arm Type
Placebo Comparator
Arm Description
Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist Placebo
Intervention Description
Behavioral ratings are conducted by a blind rater.
Primary Outcome Measure Information:
Title
CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Neill Epperson, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19488936
Citation
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.
Results Reference
result
Links:
URL
http://www.med.upenn.edu/womenswellness/
Description
Program Website

Learn more about this trial

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

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