Anxiety Disorder (Panic Disorder or GAD)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.
A study testing Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology in people with Anxiety Disorder (Panic Disorder or GAD) and Anxiety Symptoms, run by University of Santiago de Compostela at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder (Panic Disorder or GAD), Anxiety Symptoms
- What is being tested?
- Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- High-risk pregnancy or twins
- Being pharmacological treatment for anxiety and/or depression
- Not giving their consent
Trial locations and contacts
1 site in 1 country.
Alba N Val contact
Spain1 site
Facultade de Psicoloxía, Universidade de Santiago de Compostela
Santiago de Compostela, A Coruña, 15782
Mª del Carmen V Míguez, +34 881813740, mcarmen.miguez@usc.es
Alba N Val, alba.val@rai.usc.es
About this study
Official title: Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology
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.
Read the 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.
- Being tested
- Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology
- Keywords
- prevention, telematic, pregnancy, perinatal anxiety, perinatal depression
- Medical subject headings
- Anxiety Disorders, Panic Disorder, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telematic Prenatal Psychological Intervention for Preventing Anxious SymptomatologyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study startDec 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Anxiety Disorder (Panic Disorder or GAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alba Val Noguerol, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609291
- Sponsor's protocol ID
- 2021/183
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers will report study results through publications.
Publications
McCabe-Beane JE, Stasik-O'Brien SM, Segre LS. Anxiety Screening During Assessment of Emotional Distress in Mothers of Hospitalized Newborns. J Obstet Gynecol Neonatal Nurs. 2018 Jan;47(1):105-113. doi: 10.1016/j.jogn.2017.01.013. Epub 2017 May 18.
PubMed 28528808Loughnan SA, Butler C, Sie AA, Grierson AB, Chen AZ, Hobbs MJ, Joubert AE, Haskelberg H, Mahoney A, Holt C, Gemmill AW, Milgrom J, Austin MP, Andrews G, Newby JM. A randomised controlled trial of 'MUMentum postnatal': Internet-delivered cognitive behavioural therapy for anxiety and depression in postpartum women. Behav Res Ther. 2019 May;116:94-103. doi: 10.1016/j.brat.2019.03.001. Epub 2019 Mar 8. No abstract available.
PubMed 30877878Peragallo Urrutia R, Berger AA, Ivins AA, Beckham AJ, Thorp JM Jr, Nicholson WK. Internet Use and Access Among Pregnant Women via Computer and Mobile Phone: Implications for Delivery of Perinatal Care. JMIR Mhealth Uhealth. 2015 Mar 30;3(1):e25. doi: 10.2196/mhealth.3347.
PubMed 25835744Ruiz-Segovia N, Rodriguez-Munoz MF, Olivares ME, Izquierdo N, Coronado P, Le HN. Healthy Moms and Babies Preventive Psychological Intervention Application: A Study Protocol. Int J Environ Res Public Health. 2021 Nov 27;18(23):12485. doi: 10.3390/ijerph182312485.
PubMed 34886212Bayrampour H, Trieu J, Tharmaratnam T. Effectiveness of eHealth Interventions to Reduce Perinatal Anxiety: A Systematic Review and Meta-Analysis. J Clin Psychiatry. 2019 Jan 22;80(1):18r12386. doi: 10.4088/JCP.18r12386.
PubMed 30688418Loughnan SA, Joubert AE, Grierson A, Andrews G, Newby JM. Internet-delivered psychological interventions for clinical anxiety and depression in perinatal women: a systematic review and meta-analysis. Arch Womens Ment Health. 2019 Dec;22(6):737-750. doi: 10.1007/s00737-019-00961-9. Epub 2019 May 17.
PubMed 31101993Goodman JH. Women's attitudes, preferences, and perceived barriers to treatment for perinatal depression. Birth. 2009 Mar;36(1):60-9. doi: 10.1111/j.1523-536X.2008.00296.x.
PubMed 19278385Fonseca A, Canavarro MC. Women's intentions of informal and formal help-seeking for mental health problems during the perinatal period: The role of perceived encouragement from the partner. Midwifery. 2017 Jul;50:78-85. doi: 10.1016/j.midw.2017.04.001. Epub 2017 Apr 5.
PubMed 28395200Bina R, Glasser S. Factors associated with attitudes toward seeking mental health treatment postpartum. Women Health. 2019 Jan;59(1):1-12. doi: 10.1080/03630242.2017.1421286. Epub 2018 Jan 24.
PubMed 29281589Yazdanimehr R, Omidi A, Sadat Z, Akbari H. The Effect of Mindfulness-integrated Cognitive Behavior Therapy on Depression and Anxiety among Pregnant Women: a Randomized Clinical Trial. J Caring Sci. 2016 Sep 1;5(3):195-204. doi: 10.15171/jcs.2016.021. eCollection 2016 Sep.
PubMed 27752485Smith MV, Shao L, Howell H, Wang H, Poschman K, Yonkers KA. Success of mental health referral among pregnant and postpartum women with psychiatric distress. Gen Hosp Psychiatry. 2009 Mar-Apr;31(2):155-62. doi: 10.1016/j.genhosppsych.2008.10.002. Epub 2008 Dec 3.
PubMed 19269536Green SM, Donegan E, McCabe RE, Streiner DL, Agako A, Frey BN. Cognitive behavioral therapy for perinatal anxiety: A randomized controlled trial. Aust N Z J Psychiatry. 2020 Apr;54(4):423-432. doi: 10.1177/0004867419898528. Epub 2020 Jan 20.
PubMed 31957479Sanchez SE, Puente GC, Atencio G, Qiu C, Yanez D, Gelaye B, Williams MA. Risk of spontaneous preterm birth in relation to maternal depressive, anxiety, and stress symptoms. J Reprod Med. 2013 Jan-Feb;58(1-2):25-33.
PubMed 23447915Ding XX, Wu YL, Xu SJ, Zhu RP, Jia XM, Zhang SF, Huang K, Zhu P, Hao JH, Tao FB. Maternal anxiety during pregnancy and adverse birth outcomes: a systematic review and meta-analysis of prospective cohort studies. J Affect Disord. 2014 Apr;159:103-10. doi: 10.1016/j.jad.2014.02.027. Epub 2014 Feb 26.
PubMed 24679397Field T. Prenatal anxiety effects: A review. Infant Behav Dev. 2017 Nov;49:120-128. doi: 10.1016/j.infbeh.2017.08.008. Epub 2017 Sep 5.
PubMed 28886563
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology
- ClinicalTrials.gov ID
- NCT06609291
- Acronym / sponsor ID
- 2021/183
- Keywords
- prevention, telematic, pregnancy, perinatal anxiety, perinatal depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Telematic Prenatal Psychological Intervention for Preventing Anxious SymptomatologyThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- High-risk pregnancy or twins
- Being pharmacological treatment for anxiety and/or depression
- Not giving their consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telematic Prenatal Psychological Intervention for Preventing Anxious SymptomatologyThe 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. | Behavioural | Experimental group |
Primary outcome
Reduced anxiety
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).
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.
Reduced anxiety
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).
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).
Reduced anxiety
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).
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.
Reduced generalized anxiety disorder
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).
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.
1 secondary outcome
Reduced depression
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Background: PubMed 28528808McCabe-Beane JE, Stasik-O'Brien SM, Segre LS. Anxiety Screening During Assessment of Emotional Distress in Mothers of Hospitalized Newborns. J Obstet Gynecol Neonatal Nurs. 2018 Jan;47(1):105-113. doi: 10.1016/j.jogn.2017.01.013. Epub 2017 May 18.
- Background: PubMed 30877878Loughnan SA, Butler C, Sie AA, Grierson AB, Chen AZ, Hobbs MJ, Joubert AE, Haskelberg H, Mahoney A, Holt C, Gemmill AW, Milgrom J, Austin MP, Andrews G, Newby JM. A randomised controlled trial of 'MUMentum postnatal': Internet-delivered cognitive behavioural therapy for anxiety and depression in postpartum women. Behav Res Ther. 2019 May;116:94-103. doi: 10.1016/j.brat.2019.03.001. Epub 2019 Mar 8. No abstract available.
- Background: PubMed 25835744Peragallo Urrutia R, Berger AA, Ivins AA, Beckham AJ, Thorp JM Jr, Nicholson WK. Internet Use and Access Among Pregnant Women via Computer and Mobile Phone: Implications for Delivery of Perinatal Care. JMIR Mhealth Uhealth. 2015 Mar 30;3(1):e25. doi: 10.2196/mhealth.3347.
- Background: PubMed 34886212Ruiz-Segovia N, Rodriguez-Munoz MF, Olivares ME, Izquierdo N, Coronado P, Le HN. Healthy Moms and Babies Preventive Psychological Intervention Application: A Study Protocol. Int J Environ Res Public Health. 2021 Nov 27;18(23):12485. doi: 10.3390/ijerph182312485.
- Background: PubMed 30688418Bayrampour H, Trieu J, Tharmaratnam T. Effectiveness of eHealth Interventions to Reduce Perinatal Anxiety: A Systematic Review and Meta-Analysis. J Clin Psychiatry. 2019 Jan 22;80(1):18r12386. doi: 10.4088/JCP.18r12386.
- Background: PubMed 31101993Loughnan SA, Joubert AE, Grierson A, Andrews G, Newby JM. Internet-delivered psychological interventions for clinical anxiety and depression in perinatal women: a systematic review and meta-analysis. Arch Womens Ment Health. 2019 Dec;22(6):737-750. doi: 10.1007/s00737-019-00961-9. Epub 2019 May 17.
- Background: PubMed 19278385Goodman JH. Women's attitudes, preferences, and perceived barriers to treatment for perinatal depression. Birth. 2009 Mar;36(1):60-9. doi: 10.1111/j.1523-536X.2008.00296.x.
- Background: PubMed 28395200Fonseca A, Canavarro MC. Women's intentions of informal and formal help-seeking for mental health problems during the perinatal period: The role of perceived encouragement from the partner. Midwifery. 2017 Jul;50:78-85. doi: 10.1016/j.midw.2017.04.001. Epub 2017 Apr 5.
- Background: PubMed 29281589Bina R, Glasser S. Factors associated with attitudes toward seeking mental health treatment postpartum. Women Health. 2019 Jan;59(1):1-12. doi: 10.1080/03630242.2017.1421286. Epub 2018 Jan 24.
- Background: PubMed 27752485Yazdanimehr R, Omidi A, Sadat Z, Akbari H. The Effect of Mindfulness-integrated Cognitive Behavior Therapy on Depression and Anxiety among Pregnant Women: a Randomized Clinical Trial. J Caring Sci. 2016 Sep 1;5(3):195-204. doi: 10.15171/jcs.2016.021. eCollection 2016 Sep.
- Background: PubMed 19269536Smith MV, Shao L, Howell H, Wang H, Poschman K, Yonkers KA. Success of mental health referral among pregnant and postpartum women with psychiatric distress. Gen Hosp Psychiatry. 2009 Mar-Apr;31(2):155-62. doi: 10.1016/j.genhosppsych.2008.10.002. Epub 2008 Dec 3.
- Background: PubMed 31957479Green SM, Donegan E, McCabe RE, Streiner DL, Agako A, Frey BN. Cognitive behavioral therapy for perinatal anxiety: A randomized controlled trial. Aust N Z J Psychiatry. 2020 Apr;54(4):423-432. doi: 10.1177/0004867419898528. Epub 2020 Jan 20.
- Individual participant dataSharing planned: No. Researchers will report study results through publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alba N Val contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology in people with Anxiety Disorder (Panic Disorder or GAD) and Anxiety Symptoms, run by University of Santiago de Compostela at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mª del Carmen V Míguez (+34 881813740, mcarmen.miguez@usc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced anxiety (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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06609291, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.