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.

NCT06609291 | Not Yet Recruiting

• 1 other identifier: 2021/183
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorder (Panic Disorder or GAD); Anxiety Symptoms

Keywords

prevention; telematic; pregnancy; perinatal anxiety; perinatal depression

Outcome Measures

Primary Outcomes (4)

• Reduced anxiety

  The Edinburgh Depression Scale - Anxiety Subscale (EDS-3A) is the anxiety subscale of the Edinburgh Postnatal Depression Scale (EPDS). Three items (3, 4, 5) can detect anxiety in women during the perinatal period. Each of the three items has four response options (0= none, 1= somewhat, 2= quite a bit, and 3= a lot). The total score of the subscale ranges from 0 to 9. The cut-off point used in the EDS-3A to detect anxious symptomatology will be ≥ 5.

  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).

• Reduced anxiety

  The State-Trait Anxiety Inventory (STAI) assesses both the current level of anxiety and the individual's predisposition to suffering from anxiety. It consists of 40 items, 20 of which refer to the state subscale (STAI-E), with the other 20 referring to the trait subscale (STAI-R). The score for each subscale ranges from 0 to 60, with higher scores indicating higher levels of anxiety. In this case, the State Anxiety Subscale (STAI-E) will be applied and the recommended cut-off point for women is greater than 31 (75th percentile).

  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).

• Reduced anxiety

  Generalized Anxiety Disorder Screener (GAD-7) is a self-administered instrument consisting of 7 items with 4 response options. The total score ranges from 0 to 21, with the highest scores being the most severe. The cut-off point used to detect anxious symptoms will be ≥ 7.

  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).

• Reduced generalized anxiety disorder

  The SCID is a semi-structured interview that determines formal diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). To diagnose generalized anxiety, you need to have had anxiety on most days in the last 6 months in at least three contexts of your daily life and show 3 of the 6 anxiety symptoms that are described in the manual. The use of such interviews improves diagnostic reliability by standardizing the assessment process and increases the diagnostic validity by facilitating the application of DSM diagnostic criteria and the systematic enquiry of symptoms that might otherwise go unnoticed.

  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).

Secondary Outcomes (1)

• Reduced depression

  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).

Study Arms (2)

Experimental group

EXPERIMENTAL

The intervention group, who will receive the intervention protocol. The psychological intervention will consist of 7 group sessions, conducted weekly, with a duration of approximately 60 minutes each.

Behavioral: Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology

Control group

NO INTERVENTION

The control group will receive the usual care, which consists of attending follow-up and follow-up appointments for pregnancy, resolving any doubts that may arise during the process with the midwives and attending prenatal preparation classes.

Interventions

Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology BEHAVIORAL

The psychological intervention will consist of 7 group sessions, conducted weekly, with a duration of approximately 60 minutes each, with the exception of the first and last ones, which will last an hour and a half, since they will carry out the presentation and evaluation of the intervention, respectively. In turn, the program will be divided into 3 modules. Module 1. Psychoeducation and awareness about perinatal mental health, which provides information on the prevalence of anxious symptoms in the perinatal stage and the consequences for mothers and babies. Module 2. Management of emotions and thoughts. It covers 3 sessions and aims to provide strategies to identify and restructure those thoughts that harm us, as well as recognize the behaviors and emotions that they generate. Module 3. Aimed at teaching how to solve problems effec-tively and communicate in the best possible way.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over 18 years of age living in the Region of Galicia (Spain)
• Pregnant with a gestational age ≤ 16
• Understand and speak Spanish fluently
• Informed consent to participate in the study
• Accessibility to the internet and a digital device ( computer, tablet or smartphone)

You may not qualify if:

• High-risk pregnancy or twins
• Being pharmacological treatment for anxiety and/or depression
• Not giving their consent

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

Facultade de Psicoloxía, Universidade de Santiago de Compostela

Santiago de Compostela, A Coruña, 15782, Spain

Location

Related Publications (23)

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MeSH Terms

Conditions

Anxiety Disorders; Panic Disorder; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Mª del Carmen V Míguez

CONTACT

+34 881813740; mcarmen.miguez@usc.es

Alba N Val

CONTACT

alba.val@rai.usc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: December 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)