Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A

External Links