Clinical trial NCT06420674: Online Prevention of Emotional Disorders in Women Undergoing Fertility Treatments
Official title: Online Prevention of Emotional Disorders in Women Undergoing Fertility Treatments (RE-FER Moodle)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility
Emotional Disorder
Anxiety Depression
Keywords: Unified Protocol
Prevention
Anxiety
Depression
Reproduction
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario de Castellón
name: Hospital Universitario La Plana de Castellón
First posted: 2024-05-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will be offered to all women undergoing artificial inseminations in two public hospitals.
Primary purpose: PREVENTION

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.

Detailed description: Women who can not achieve a spontaneous pregnancy (i.e., 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 women's lives. It has been reported that fertility treatments are associated with high levels of stress, worse quality of life, high interference with women's 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 (i.e., lack of time) and logistical barriers (i.e., 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.

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age.
* Have a good understanding of Spanish.
* Have started fertility treatment (at least one artificial insemination received).
* Signed the informed consent.

Exclusion Criteria:

* Not having Internet access to access the web-page.
* Having a diagnosis of severe mental disorder.
* Active suicidal ideation at the time of evaluation.

Primary outcomes:
measure: Overall Depression Severity and Impairment Scale (ODSIS)
timeFrame: Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment.
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment.
measure: Fertility Problem Inventory (FPI)
timeFrame: Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment.
measure: Fertility Quality of Life Questionnaire (FertiQoL)
timeFrame: Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment.
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment.
measure: The Multidimensional Emotional Disorder Inventory (MEDI)
timeFrame: Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment.
measure: Web-page adherence
timeFrame: Post-intervention (11 weeks from pre-intervention assessment).
measure: Adaptation of the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-intervention (11 weeks from pre-intervention assessment).
measure: Unified Protocol Satisfaction questionaire
timeFrame: Post-intervention (11 weeks from pre-intervention assessment).
Secondary outcomes:
Other outcomes:
Locations:
city: Teruel
country: Spain
facility: Jorge Osma
Study officials:
References: