Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420674
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-14
Brief Title:
Online Prevention of Emotional Disorders in Women Undergoing Fertility Treatments
Sponsor:
Jorge Javier Osma López
Organization:
Instituto de Investigación Sanitaria Aragón
Study Overview
Official Title:
Online Prevention of Emotional Disorders in Women Undergoing Fertility Treatments RE-FER Moodle
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RE-FER moodle
Brief Summary:
The main aim of this pilot study is to study the clinical utility and acceptability of a transdiagnostic psychological intervention the Unified Protocol delivered in online format to prevent the onset of emotional disorders in a sample of women undergoing fertility treatments artificial insemination The main questions it aims to answer are
1 Can the Unified Protocol help to prevent the onset of emotional disorders during fertility treatments The investigators expect to find a maintenance or improvement in anxiety and depressive symptoms as well as on quality of life and fertility-related stress
2 Would the Unified Protocol delivered in online format be well accepted by women undergoing fertility treatments The investigators expect to find high satisfaction rates both with the Unified Protocol contents and the online format
1 Can the Unified Protocol help to prevent the onset of emotional disorders during fertility treatments The investigators expect to find a maintenance or improvement in anxiety and depressive symptoms as well as on quality of life and fertility-related stress
2 Would the Unified Protocol delivered in online format be well accepted by women undergoing fertility treatments The investigators expect to find high satisfaction rates both with the Unified Protocol contents and the online format
Detailed Description:
Women who can not achieve a spontaneous pregnancy ie couples who had fertility problems single women or same-sex couples frequently ask for fertility treatments These treatments can provide the opportunity to get the desired pregnancy However they are also experienced as a highly stressful situation which has a direct impact on womens lives It has been reported that fertility treatments are associated with high levels of stress worse quality of life high interference with womens life and the development of emotional disorders such as anxiety and depression Between 25 and 65 of women undergoing fertility treatments suffer from anxiety and depressive symptoms frequently with high comorbidity rates between these two psychological conditions Also worrisome these emotional disorders are one of the most notable reasons to discontinue fertility treatments
In this scenario different national and international organizations have postulated the need to implement psychological assessments and interventions in women undergoing fertility treatments However some personal ie lack of time and logistical barriers ie lack of psychologist in Human Reproduction Units and high distances to the hospital impede that these psychological programs are finally implemented in Human Reproduction Units
New Information and Communication Technologies have been widely developed to provide psychological care in populations suffering emotional disorders even in women undergoing fertility treatments However these technology-based solutions have not been yet implemented in the Spanish national healthcare system
According to this information the purpose of this study is to explore the clinical utility and acceptability of a web-based transdiagnostic psychological intervention the Unified Protocol to prevent the onset of anxiety and depressive symptoms in women undergoing artificial inseminations
In this scenario different national and international organizations have postulated the need to implement psychological assessments and interventions in women undergoing fertility treatments However some personal ie lack of time and logistical barriers ie lack of psychologist in Human Reproduction Units and high distances to the hospital impede that these psychological programs are finally implemented in Human Reproduction Units
New Information and Communication Technologies have been widely developed to provide psychological care in populations suffering emotional disorders even in women undergoing fertility treatments However these technology-based solutions have not been yet implemented in the Spanish national healthcare system
According to this information the purpose of this study is to explore the clinical utility and acceptability of a web-based transdiagnostic psychological intervention the Unified Protocol to prevent the onset of anxiety and depressive symptoms in women undergoing artificial inseminations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None