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

NCT01277354 | Terminated Results

• 2 other identifiers: 810277March of Dimes Foundation
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder; Stress Disorders; Anxiety; Depression

Keywords

Cognitive Processing Therapy (CPT)

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Study Arms (2)

Cognitive Processing Therapy

ACTIVE COMPARATOR

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

Behavioral: Cognitive Processing Therapy

Waitlist

PLACEBO COMPARATOR

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

Behavioral: Waitlist Placebo

Interventions

Cognitive Processing Therapy BEHAVIORAL

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.

Cognitive Processing Therapy

Waitlist Placebo BEHAVIORAL

Behavioral ratings are conducted by a blind rater.

Waitlist

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• March of Dimes: collaborator

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104, United States

Location

Related 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.

  PMID: 19488936 RESULT

Related Links

• Program Website

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

The limitations of this trial include an insufficient number of subjects enrolled which prohibits our ability to analyze the data in any meaningful fashion.

Results Point of Contact

• Title: Cynthia Neill Epperson, M.D.
• Organization: University of Pennsylvania

cepp@mail.med.upenn.edu

215-573-8871

Study Officials

• Cynthia Neill Epperson, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: January 14, 2011
• Study Start: April 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 17, 2017
• Results First Posted: August 8, 2016

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)