Prevention of Postpartum Traumatic Stress (PTSD) in Mothers With Preterm Infants.
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Davidson Trauma Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- BDI-II [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- CAPUTE [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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.
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Please refer to this study by its ClinicalTrials.gov identifier: 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|