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| ID | Type | Description | Link |
|---|---|---|---|
| March of Dimes Foundation | Other Grant/Funding Number | 12-FY07-679 |
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Loss of funding
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| Name | Class |
|---|---|
| March of Dimes | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Processing Therapy | Active Comparator | Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings. |
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| Waitlist | Placebo Comparator | Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Neill Epperson, M.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19488936 | Result | 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. |
| Label | URL |
|---|---|
| Program Website | View source |
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Recruitment for this project was slow and only two subjects matriculated during the period that this project was active.
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| ID | Title | Description |
|---|---|---|
| FG000 | CPT Group | Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings. |
| FG001 | Waitlist Group | Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Waitlist Placebo | Behavioral | Behavioral ratings are conducted by a blind rater. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CPT Group | Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings. |
| BG001 | Waitlist Group | Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6 | 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. | 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. | Posted | Count of Participants | Participants | 6 weeks |
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Through study completion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CPT Group | Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings. | 0 | 1 | 0 | 1 | ||
| EG001 | Waitlist Group | Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy. | 0 | 1 | 0 | 1 |
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The limitations of this trial include an insufficient number of subjects enrolled which prohibits our ability to analyze the data in any meaningful fashion.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Neill Epperson, M.D. | University of Pennsylvania | 215-573-8871 | cepp@mail.med.upenn.edu |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D040921 | Stress Disorders, Traumatic |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| >=65 years |
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| Male |
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