Development of Cognitive Behavioral Therapy based midwifery Care Program for Perinatal Depression and Anxiety in Preterm High-risk Pregnant Women.

UMIN ID: UMIN000054078

Registered date:07/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: High-risk Pregnant Women Diagnosed with Threatened Premature Labor, Cervical Incompetency, Premature Rupture of the Membranes, Placenta Previa, Hypertensive Disorders of Pregnancy and Fetal Growth Restriction
• Date of first enrollment: 2024/04/08
• Target sample size: 3
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The program is based on standard midwifery care from admission to the one-month postpartum check-up. It consists of six 30-minute interventions, including a cognitive-behavioral therapy component.The initial session provides psychoeducation on perinatal depression and anxiety and promotes self-understanding. This includes raising awareness of one's thinking habits and identifying whether one has fallen into a vicious cycle of thinking, using the cognitive-behavioral model. The second session aims to capture cognitions that are strongly associated with emotions, such as anxiety about preterm birth, in order to modify cognitive biases and prepare the mind for the possibility of preterm birth. The third intervention aims to transform the cognitive experience of premature birth into a positive one. This is based on the fact that the treatment resulted in the continuation of the pregnancy. The fourth session suggests integrating NICU visits and childcare behaviors into daily life as enjoyable activities. The objective of the fifth session is to facilitate behavioral change by collaboratively addressing post-discharge difficulties and problems through problem-solving techniques. The sixth session reflects on the cognitive-behavioral therapy techniques used thus far and shares what can be applied to childcare after the one-month check-up.

Outcome(s)

• Primary Outcome: The change in STAI (State-Trait Anxiety Inventory) scores before and after the program intervention is calculated for each case.
• Secondary Outcome: Changes in the EPDS (Edinburgh Postnatal Depression Scale), PHQ-9 (Patient Health Questionnaire-9), GAD-7 (Generalized Anxiety Disorder-7), MIBS-J (Mother to Infant Bonding Scale-Japanese version) and EQ-5D-5L (EuroQol-5dimension-5level) before and after the program. Post-program impressions.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: Pregnant women with psychiatric complications, multiple gestations, fetal diseases, or who are unable to communicate in Japanese.

Related Information

• Primary Sponsor: Tokyo Women's Medical University
• Source(s) of Monetary Support: Chiba University