Anxiety, Depression, Post-traumatic Stress Disorder, Stress Disorders
Conditions
Keywords
Cognitive Processing Therapy (CPT)
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.
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALWaitlist Placebo
Behavioral ratings are conducted by a blind rater.
Sponsors
March of Dimes
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment for this project was slow and only two subjects matriculated during the period that this project was active.
Participants by arm
| Arm | Count |
|---|---|
| CPT Group Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings. | 1 |
| Waitlist Group Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Total | CPT Group | Waitlist Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 2 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
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.
Time frame: 6 weeks
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPT Group | CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6 | 1 Participants |
| Waitlist Group | CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6 | 1 Participants |