Prevention of Postpartum Traumatic Stress (PTSD) in Mothers With Preterm Infants.
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|ClinicalTrials.gov Identifier: NCT01307293|
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : November 19, 2014
The purpose of the study includes:
- To develop a treatment manual and pilot test this treatment intervention which is designed to prevent and reduce psychological distress in parents who have infants hospitalized in the neonatal intensive care unit (NICU).
- To conduct a treatment intervention study in which parents of NICU infants will receive a 6-12 session treatment designed to reduce psychological distress, and to compare outcomes with parents who do not receive the intervention.
We hope to learn whether or not a simple psychotherapeutic and psychoeducational intervention offered to parents of NICU infants can prevent or minimize the development of symptoms of psychological distress in parents, including symptoms of anxiety and depression and posttraumatic stress disorder (PTSD).
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic||Behavioral: Cognitive behavior therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of a Brief Cognitive Behavioral Intervention Designed to Prevent and Reduce Symptoms of Posttraumatic Stress in Mothers of Preterm Infants.|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2014|
Experimental: Cognitive Behavior Therapy
6-12 sessions of Cognitive Behavior Therapy to address PTSD symptoms and parenting issues related to premature infants.
Behavioral: Cognitive behavior therapy
6 or 12 sessions of cognitive behavior therapy.
No Intervention: Placebo comparison
Education regarding NICU parenting issues.
- Davidson Trauma Scale [ Time Frame: 6 months ]
- BDI-II [ Time Frame: 6 months ]
- CAPUTE [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307293
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Richard J Shaw||Stanford University|
|Principal Investigator:||Sarah McCue Horwitz||Stanford University|