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

Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186472
• Other study ID #: NIH 5 T 32 MH19908-7
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: May 31, 2011

Study information

• Verified date: December 2006
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Stress Disorder
• Anxiety
• Depression
• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute

Intervention

Behavioral:
• Brief Cognitive Behavioral Treatment

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States,