Prenatal Telepsychological Intervention for Preventing Anxiety: A Study Protocol.

Anxiety is one of the most frequent disorders during the perinatal stage that is associated with adverse health effects in women and their babies. In spite of this, preventive interventions during this stage are scarce. A long-distance intervention carried out during pregnancy can be an effective and accessible resource to help improve women's emotional state. The objective of this study is to present and assess the effectiveness of a telepsychology cognitive-behavioral preventive intervention during pregnancy to manage anxiety. A random clinical trial will be carried out among pregnant women in Spain. The psychological intervention will take place via videoconference in seven weekly sessions, lasting one hour each, with groups of 6-8 pregnant women. Study outcomes will be collected via online questionnaires at five points in time: pre-intervention (baseline: t0), post-intervention (baseline: t1), follow-up at 1 month (t2), follow-up at 3 months (t3) and follow-up at 6 months (t4). The control group will receive usual pregnancy care (attendance at pregnancy follow-up consultations and information and answers to frequently asked questions provided by the midwife). 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 anxiety and depressive symptomatology. The primary outcome measure is the difference in the mean anxiety score between the intervention and control groups assessed by the Edinburgh Depression Scale-Anxiety Subscale (EDS-3A), the State-Trait Anxiety Inventory (STAI) and Generalized Anxiety Disorder Screener (GAD-7) at the end of the intervention and at 1, 3 and 6 months postpartum. Generalized anxiety disorder (GAD) will be evaluated with the SCID clinical interview at the same time points. The secondary outcome will be determined by using the EPDS at the same time points. The results will determine whether a cognitive behavioral therapy applied via videoconference is well accepted by pregnant women, and if it is effective in preventing anxiety and emotional symptoms during the perinatal stage. If this intervention is an effective and useful resource among pregnant women, it can be implemented as a tool in Spanish healthcare.