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

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

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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