Clinical trial NCT06609291: 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.
Official title: Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety Disorder (Panic Disorder or GAD)
Anxiety Symptoms
Keywords: prevention
telematic
pregnancy
perinatal anxiety
perinatal depression
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Anxiety is one of the most frequent disorders during the perinatal stage. Its prevalence is between 15% and 23% during the pregnancy, and between 3,7% and 15,0% during postpartum. In Spain, the prevalence of anxiety ranges from 16.8% to 19.5% throughout pregnancy. Additionally, one in ten women will experience comorbid anxiety and depression during pregnancy and one in twelve during the postpartum period. Although its prevalence is high, research in treating anxiety during this period is recent.

Perinatal anxiety is associated with adverse health effects for women and their babies. Regarding mothers, it has been associated to an increased probability of developing postpartum depression, a higher risk of preeclampsia, obstetric complications and bonding problems. As for newborns, they have been found to be more likely to have lower birth weight and poor cognitive development, among others. Hence the importance of detecting and intervening early in prenatal anxiety to promote the well-being of mothers and children, because despite the negative consequences associated with perinatal anxiety, the majority of women are not detected or treated, as less than 15% receive treatment. Given the high prevalence of prenatal anxiety and the potential for adverse consequences, early treatment is recommended. Evidence on the effectiveness of psychological interventions during pregnancy is scarce highlighting the importance of having specific interventions.

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.

During pregnancy, women frequently go to health services and are more willing to receive help because they believe it will have a positive impact on their baby. However, there are barriers to accessing interventions during this period, such as lack of information about emotional problems, available and effective intervention options, as well as practical limitations of access to in-person treatment, such as costs, geographical distance, waiting lists or logistical problems such as attending appointments. Furthermore, due to the stigmatization of mental health, especially during the perinatal period, women are reluctant to attend specialized mental health clinics in person.

The advances in information and communication technologies make it possible to have interventions via the internet, which can be carried out through computers, tablets or smartphones. They have the advantage of helping to overcome the aforementioned barriers, since they improve the acceptance of the intervention, are more flexible and accessible. Systematic reviews of internet-based interventions during the perinatal period conclude that these interventions can reduce anxiety among mothers and improve depressive and anxious symptoms.

During the perinatal stage, interventions carried out through the internet represent a tool with great potential, as they tend to be more attractive, since they reduce the need to travel, one of the barriers associated with low access to treatments for psychological problems during the perinatal period. Peragallo-Urrutia et al. found that 94.0% of pregnant and postpartum women use the internet, and 83% indicate their willingness to receive an online intervention in the perinatal period.

A form of therapy applied online is teletherapy, which has gained special importance since the COVID-19 pandemic. This form of treatment is carried out following a process similar to that of face-to-face therapy, although the interaction occurs electronically. A systematic review on telepsychology showed the effectiveness of different approaches, mostly based on the cognitive behavioral model, to reduce emotional distress. However, most of the research on the prevention of perinatal anxiety through the internet is unguided interventions, where participants access an application or web platform and view the material whenever they want and do not contact with an online healthcare professional at any moment or guided, where the participants in addition to accessing the program material, have contact (via online and/or telephone) with a professional at some point during the intervention. To date, no protocol or study has been published on the effectiveness of cognitive behavioral therapy applied in a telematic format, that is, through video calls. Having an intervention developed through videoconferencing could help reduce the limitations of unguided therapies, since they do not offer a direct interaction between the therapist and the patient, nor do they address the needs that may arise during said intervention.

On the other hand, it is worth remembering the high comorbidity between anxiety and depression. In a review and meta-analysis whose objective was to evaluate the effectiveness of psychological interventions to reduce perinatal anxiety, it was found that psychological interventions aimed at reducing anxiety during the perinatal stage were also effective in reducing symptoms of depression. This supports research suggesting that transdiagnostic interventions targeting both anxious and depressive symptoms tailored to the perinatal period, may be more beneficial than disorder-specific interventions, and indicates the need to create transdiagnostic interventions to address symptoms of anxiety and depression in women during the perinatal stage, since these comorbidities are generally not recognized or treated.

The objective of this study will be to evaluate the effectiveness of a telematic cognitive-behavioral preventive intervention during pregnancy, for the management of anxiety symptoms.

After completion of the baseline questionnaire, participants will be randomly assigned to either the intervention or control group using block randomization, a 2:1 ratio, using an online randomization program. Study personnel are unaware of which treatment group each participant will be assigned to at the time of the baseline assessment.

Referring to clinical trials on psychological interventions for perinatal depression and anxiety, the power calculation was based on detecting an effect size of medium magnitude (d = 0.55) at follow-ups among participants. The investigators calculated that a sample size of 45 participants would result in a power of 0,95 with alpha set at 0,05. To guard against an expected loss to follow-up of approximately 30%, the investigators planned to enroll 65 participants in each condition.

This study is conducted according to the principles expressed in the Declaration of Helsinki and has been approved by Comité Ético de Investigación de Galicia (CEIC) of Spain. All participants are guaranteed confidentiality of the information collected throughout the process. Participation will be completely voluntary and free, and no incentive (financial or otherwise) will be received for participation in the study.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Reduced anxiety
timeFrame: 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).
measure: Reduced anxiety
timeFrame: 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).
measure: Reduced anxiety
timeFrame: 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).
measure: Reduced generalized anxiety disorder
timeFrame: 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:
measure: Reduced depression
timeFrame: 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).
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Facultade de Psicoloxía, Universidade de Santiago de Compostela
state: A Coruña
Study officials:
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