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Prevention of Postpartum Traumatic Stress (PTSD) in Mothers With Preterm Infants.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307293
First Posted: March 2, 2011
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
  Purpose

The purpose of the study includes:

  1. 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).
  2. 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 Intervention
Stress Disorders, Post-Traumatic Behavioral: Cognitive behavior therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Davidson Trauma Scale [ Time Frame: 6 months ]
  • BDI-II [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • CAPUTE [ Time Frame: 6 months ]

Enrollment: 110
Study Start Date: April 2011
Study Completion Date: June 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

English and Spanish-speaking mothers greater than 18 years of age of infants in the LPCH NICU >=26 weeks of gestation are eligible for screening.

Exclusion Criteria:

  1. Mothers of children awaiting cardiac surgery, those who have congenital abnormities and those who are unlikely to survive, will be excluded.
  2. Mothers of NICU infants who are found on their routine clinical psychosocial evaluation to be at high psychiatric risk (i.e., those with either psychotic symptoms or suicidal or infanticidal ideation) will also be excluded. These parents, however, will be referred for and receive appropriate mental health intervention.
  3. Mothers who do not speak English or Spanish, or who do not have the ability to understand the questionnaires will be excluded.
  4. Mothers who have active and current symptoms of suicidal ideation, or psychotic symptoms (delusions or hallucinations) as identified by self report or following a diagnostic interview will be excluded from the study, but will also be referred for emergency psychiatric evaluation.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Richard J Shaw Stanford University
Principal Investigator: Sarah McCue Horwitz Stanford University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01307293     History of Changes
Other Study ID Numbers: SU-02172011-7504
First Submitted: February 28, 2011
First Posted: March 2, 2011
Last Update Posted: November 19, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders