Randomized Controlled Trial of a Brief Cognitive Behavioral Intervention Designed to Prevent and Reduce Symptoms of Posttraumatic Stress in Mothers of Preterm Infants

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Study Type/Phase: Interventional
Status: Recruiting

The purpose of this study is to conduct a treatment intervention study to reduce psychological distress in mothers of NICU infants. Mothers will receive six 90-minute sessions of group-based treatment designed to reduce psychological distress, including symptoms of anxiety, depression, and posttraumatic stress disorder (PTSD). A prior clinical trial found a statistically significant reduction in both trauma symptoms and depression in NICU mothers who received the 6-session, manual-guided individual intervention (Shaw et al., 2013). Group psychotherapy has been shown to significantly reduce symptoms of PTSD (Schwartze et al., 2017). A group model may offer both immediate and sustained benefits to parents of preterm infants, as well as to the infants themselves.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Has an infant who was born between 23-34 weeks
  • Has an infant who is hospitalized in the El Camino Hospital NICU
  • Aged > 18 years at time of consent

Principal Investigator

Malathi Balasundaram, MD


Stanford University

NCT Number



Michelle Backer, Clinical Research Program Lead

Elizabeth Hoang, Clinical Research Intern

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.