Intervention to Decrease Anxiety in Parents of Infants in the Neonatal Intensive Care Unit (NICU)

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. Identifier: NCT00186472
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 2, 2011
Information provided by:
Stanford University

Brief Summary:
Infants born premature face numerous medical problems, causing significant anxiety for their parents. Parents experience a range of negative emotions including concern for the health and well being of their fragile infant, guilt, and disappointment. Research has indicated that having an infant in the Neonatal Intensive Care Unit (NICU) is highly stressful for parents and multiple studies have demonstrated that parents can develop significant psychological reactions to this experience. Specifically, many parents develop clinically significant anxiety disorders such as acute stress disorder (ASD) and posttraumatic stress disorder (PTSD). This not only impacts the mental well-being of the parents, but also can lead to problems with the parent-infant relationship, and, in turn, negatively impact the infant and the family as a whole. Despite the reported negative effects parents experience due to the stress of having an infant on the NICU, surprisingly little research has examined how to reduce parents' symptoms of anxiety. Because parents play an essential role in the care of their infant after discharge from the NICU, treating the parent's emotional distress is highly important. The purpose of this study is to examine the efficacy of a cognitive-behaviorally based intervention in reducing parents' symptoms of anxiety associated with having an infant on the NICU. This treatment is modeled after treatments that have proven effective with parents of children with other types of medical problems, for example, parents of children with cancer. It is the hope of the investigators that this intervention will effectively reduce symptoms of anxiety of NICU parents as well as the likelihood of developing subsequent psychological disorders.

Condition or disease Intervention/treatment Phase
Anxiety Acute Stress Disorder Posttraumatic Stress Disorder Depression Behavioral: Brief Cognitive Behavioral Treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. 18 years of age or older;
  2. Participants speak either English or Spanish;
  3. The participant's infant is expected to live;
  4. The participant's infant was born at Lucile Packard Children's Hospital or transferred to the hospital within 72 hours;
  5. Participant's infant is over 1000 grams

Exclusion Criteria:

  1. Individuals under 18 years of age;
  2. Individuals who do not speak either English or Spanish;
  3. Individuals whose infant was not born at or transferred to (within 72 hours of The infant's birth) Lucile Packard Children's Hospital;
  4. Individuals whose infant has a life threatening condition and is not expected to survive;
  5. Current drug abuse/dependence

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 identifier (NCT number): NCT00186472

United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Rebecca S Bernard, Ph.D. Stanford University

Responsible Party: Richard Shaw, M.D., Stanford University School of Medicine Identifier: NCT00186472     History of Changes
Other Study ID Numbers: NIH 5 T 32 MH19908-7
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: December 2006

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