Online Prevention of Emotional Disorders in Women Undergoing Fertility Treatments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Impact of Personalized Prognostic Counseling on IVF Patient's Experience and Treatment Utilization

NCT06319573

Infertility

RECRUITING NA

Conversion of in Vitro Fertilization Cycles to Intrauterine Inseminations in Patients With a Poor Ovarian Response to Stimulation

NCT03362489

Infertility

COMPLETED NA

Effectiveness of Web-based Teaching to Traditional Patient Education in the Use of Injectable Fertility Medications

NCT02420964

Infertility

COMPLETED NA

COVID-19 in ART: Perception and Experience

NCT04456010

COVID19 Fertility Issues ART

COMPLETED

COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation

NCT02288143

Infertility

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility Emotional Disorder Anxiety Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study will be offered to all women undergoing artificial inseminations in two public hospitals.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Masking is not applicable in this study as it includes only one condition.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RE-FER web

The study will be offered to all women receiving artificial inseminations in two Spanish public hospitals (Hospital Universitario General de Castellón and Hospital Universitario La Plana).

Group Type EXPERIMENTAL

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type BEHAVIORAL

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders is a psychological intervention that focuses on a wide range of emotional disorders (i.e., anxiety, depression and related disorders). It allows care for comorbid disorders, subclinical or unspecified symptoms reducing associated costs and improving response to treatment.

In our study, the Unified Protocol preventive program will be applied throughout 10 online modules. Women will have access to a web-page (moodle version) that includes audiovisual materials (e.g., written manual, videos, editable registers) and psychological assessments.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders is a psychological intervention that focuses on a wide range of emotional disorders (i.e., anxiety, depression and related disorders). It allows care for comorbid disorders, subclinical or unspecified symptoms reducing associated costs and improving response to treatment.

In our study, the Unified Protocol preventive program will be applied throughout 10 online modules. Women will have access to a web-page (moodle version) that includes audiovisual materials (e.g., written manual, videos, editable registers) and psychological assessments.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No