An interventional study of Cognitive Processing Therapy and Waitlist Placebo in Post-traumatic Stress Disorder, Stress Disorders and Anxiety, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2017-04-17.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
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.
1,148 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 2 is below the median of 60 across 909 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
Behavioral: Cognitive Processing Therapy
Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
Behavioral: Waitlist Placebo
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.
Behavioral ratings are conducted by a blind rater.
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.
Time frame: 6 weeks
Recruitment for this project was slow and only two subjects matriculated during the period that this project was active.
| Milestone | CPT Group | Waitlist Group |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
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.
| Participants | CPT Group | Waitlist Group |
|---|---|---|
| CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6 | 1 | 1 |
Collected over Through study completion. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CPT Group | — | 0/1 (0%) | 0/1 (0%) |
| Waitlist Group | — | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | CPT Group | Waitlist Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | CPT Group | Waitlist Group | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | CPT Group | Waitlist Group | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
Plan to share: No
This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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