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

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University of Pennsylvania

Status

Terminated

Conditions

Post-traumatic Stress Disorder
Depression
Anxiety
Stress Disorders

Treatments

Behavioral: Waitlist Placebo
Behavioral: Cognitive Processing Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01277354
March of Dimes Foundation (Other Grant/Funding Number)
810277

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2 participants in 2 patient groups, including a placebo group

Cognitive Processing Therapy
Active Comparator group
Description:
Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
Treatment:
Behavioral: Cognitive Processing Therapy
Waitlist
Placebo Comparator group
Description:
Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
Treatment:
Behavioral: Waitlist Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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