Anxiety is One of the Most Frequent Disorders During the Perinatal Stage Which is Associated with Adverse Health Effects for Women and Their Babies. This Study Will Be to Evaluate the Effectiveness of a Telematic Cognitive-behavioral Preventive Intervention to Manage Anxiety During Pregnancy.

Anxiety is one of the most frequent disorders during the perinatal stage which is associated with adverse health effects for women and their babies. In spite of this, preventive interventions during this stage are scarce. The National Institute for Health and Clinical Excellence recommends psychological interventions, such as cognitive behavioral therapy, as a first-line treatment for mild and moderate prenatal anxiety. Early detention of anxiety symptoms in the perinatal stage can help prevent the development of more serious mental health problems. However, there are barriers to accessing interventions during this period. A long-distance intervention carried out during the pregnancy can be an effective and accessible resource to help improve women's emotional state. The primary objective of the current study is to determine whether a preventive psychological intervention developed through videoconferencing is superior to the usual care during pregnancy (attendance at pregnancy follow-up consultations and information and answers to frequently asked questions provided by the midwife) to prevent anxious symptoms during pregnancy. The secondary objective is to examine whether this same intervention is more effective than usual care in preventing depressive symptoms during pregnancy, as well as anxious and depressive symptoms in the postpartum. A random clinical trial will be carried out among pregnant women in Spain. A recruitment of 130 participants is proposed with random assignment to one of two conditions (65 per group): (a) the experimental group will receive the cognitive-behavioral intervention via videoconference or (b) the control group will receive usual care pregnancy (attendance at pregnancy follow-up consultations and information and answers to frequently asked questions provided by the midwife). The psychological intervention will take place via videoconference in seven weekly sessions, lasting one hour each, with groups of 6 - 8 pregnant women. A blinded assessment will be conducted through online self-administered testing at baseline, post-intervention, and at follow-up at one month, 3 and 6 months. A clinical interview will also be conducted to evaluate generalized anxiety disorder (GAD), at the same time times. Our primary hypothesis is that the intervention will decrease the frequency of women who present anxious symptomatology during pregnancy. The second objective is to analyze the effectiveness of this intervention to prevent depressive symptomatology during pregnancy, as well as postpartum anxious and depressive symptomatology.

NCT Number	NCT06609291
Lead Sponsor	University of Santiago de Compostela
Conditions	Anxiety Disorder (Panic Disorder or GAD), Anxiety Symptoms
Enrollment	130 participants
Start Date	2024-12
Primary Completion	2025-09 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2024-09-25