An interventional study of Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology in Anxiety Disorder (Panic Disorder or GAD) and Anxiety Symptoms, sponsored by University of Santiago de Compostela. Not yet recruiting at 1 site in Spain. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by University of Santiago de Compostela · Not applicable, Interventional, and Prevention
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.
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.
270 studies on the registry are indexed under Panic Disorder; 37 are open to participants now.
This study's planned enrollment of 130 is above the median of 77 across 215 interventional studies indexed under Panic Disorder.
Browse Panic Disorder studies →University of Santiago de Compostela is the lead sponsor of 60 studies on the registry; 12 are open to participants now.
Compared within Panic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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 depression
The Edinburgh Depression Scale (EPDS) is a self-reported questionnaire consisting of 10 items with 4 response options. The scores range between 0 and 30, with higher scores indicating a greater severity of depression. The Spanish validation of the EPDS for use in pregnancy will be used, and determines that the most appropriate cut-off point for screening for probable antenatal depression is 10.
Time frame: 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).
Plan to share: No — Researchers will report study results through publications.
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University of Santiago de Compostela