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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01277354
• Collaborator: March of Dimes (Other)
• Enrollment: 2
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-traumatic Stress Disorder; Stress Disorders; Anxiety; Depression	Behavioral: Cognitive Processing Therapy; Behavioral: Waitlist Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cognitive Processing Therapy Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.	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.
Placebo Comparator: Waitlist Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.	Behavioral: Waitlist Placebo; Behavioral ratings are conducted by a blind rater.

Outcome Measures

Primary Outcome Measures

1. CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6 [6 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• March of Dimes

Investigators

• Principal Investigator: Cynthia Neill Epperson, M.D., University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Program Website

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01277354
• Other Study ID Numbers: 810277; March of Dimes Foundation
• First Posted: Jan 14, 2011
• Last Update Posted: Apr 17, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Pennsylvania: Cognitive Processing Therapy (CPT)
• Additional relevant MeSH terms: Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Recruitment Details	Recruitment for this project was slow and only two subjects matriculated during the period that this project was active.

Arm/Group Title	CPT Group	Waitlist Group
Arm/Group 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.
Period Title: Overall Study
STARTED	1	1
COMPLETED	1	1
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	CPT Group	Waitlist Group	Total
Arm/Group 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.	Total of all reporting groups
Overall Participants	1	1	2
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 100%	1 100%	2 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	1 100%	1 100%	2 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%	1 100%	2 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Please note that there were only a total of 2 participants involved in this study. Funding was lost to continue and the study was terminated.

Arm/Group Title	CPT Group	Waitlist Group
Arm/Group 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.
Measure Participants	1	1
Count of Participants [Participants]	1 100%	1 100%

Adverse Events

Time Frame	Through study completion
Arm/Group Title	CPT Group		Waitlist Group
Arm/Group 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.
All Cause Mortality
	CPT Group		Waitlist Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CPT Group		Waitlist Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	CPT Group		Waitlist Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.