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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01307293
First received: February 28, 2011
Last updated: May 10, 2011
Last verified: May 2011
  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
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.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Davidson Trauma Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • BDI-II [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NCAST [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: April 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307293

Contacts
Contact: Richard J Shaw, MD (650) 723-5457 rjshaw@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Richard J Shaw, MD    650-723-5457    rjshaw@stanford.edu   
Principal Investigator: Sarah McCue Horwitz         
Principal Investigator: Richard J Shaw         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Richard J Shaw Stanford University
Principal Investigator: Sarah McCue Horwitz Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard J Shaw, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01307293     History of Changes
Other Study ID Numbers: SU-02172011-7504
Study First Received: February 28, 2011
Last Updated: May 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014