Effectiveness of Cognitive Processing Therapy in Pregnant Women With a History of Pregnancy Loss/… (NCT01277354) | Clinical Trial Compass
TerminatedNot Applicable
Effectiveness of Cognitive Processing Therapy in Pregnant Women With a History of Pregnancy Loss/Complication
Stopped: Loss of funding
United States2 participantsStarted 2010-04
Plain-language 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.
Who can participate
Age range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 adjustm…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6