Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609291
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens 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
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 37 and 150 during postpartum In Spain the prevalence of anxiety ranges from 168 to 195 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 940 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 andor 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 21 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 055 at follow-ups among participants The investigators calculated that a sample size of 45 participants would result in a power of 095 with alpha set at 005 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
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 940 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 andor 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 21 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 055 at follow-ups among participants The investigators calculated that a sample size of 45 participants would result in a power of 095 with alpha set at 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None