Online Prevention of Emotional Disorders in Women Undergoing Fertility Treatments

NCT06420674 | Not Yet Recruiting

• 1 other identifier: IPES/RE-FER/moodle
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Infertility; Emotional Disorder; Anxiety Depression

Keywords

Unified Protocol; Prevention; Anxiety; Depression; Reproduction

Outcome Measures

Primary Outcomes (9)

• Overall Depression Severity and Impairment Scale (ODSIS)

  This questionnaire consist of 5 items that evaluate the frequency and the intensity of depressive symptoms and their interference in life (e.g., work, school and social life). It is responded on a 5-point Likert scale (0=No depression - 4=The worst depression possible). The total score range from 0 to 20 points. Higher scores are indicative of greater severity and functional impairment as a result of depressive symptoms. In the Spanish population the clinical cut-off has been stablished in 10 points.

  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.

• Overall Anxiety Severity and Impairment Scale (OASIS)

  It consist of 5 items that evaluate the frequency and the intensity of anxious symptoms and their interference with the person's work or school life and social life. It is responded on a 5-point Likert scale (0=No anxiety- 4=The worst anxiety possible). The total score range from 0 to 20 points. Higher scores are indicative of greater severity and functional impairment as a result of anxious symptoms. In the Spanish population the clinical cut-off has been stablished in 10 points.

  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.

• Fertility Problem Inventory (FPI)

  It is composed by 46 items that assess infertility-related stress. It is responded by a 7-points Likert scale (0=completely disagree - 6=completely agree). It is possible to obtain a total score of perceived stress and also it is possible to calculate 5 subscale scores (social concerns, sexual concerns, relationship concerns, need for parenthood and, reject to child-free living). Higher scores indicate greater stress.

  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.

• Fertility Quality of Life Questionnaire (FertiQoL)

  This instrument is composed by 36 items assessing quality of life during fertility treatments. It is responded by a 5-point Likert scale (0=very bad - 4 = very good). Total scores range from 0 to 136 points, higher global scores indicating greater quality of life.

  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.

• Difficulties in Emotion Regulation Scale (DERS)

  Consists of 36-item of six dimension of emotion regulation (nonacceptance of emotions, difficulties in engaging in goal-directed behaviours, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies and lack of emotional clarity). Items are rated on a scale of 1 ("almost never \[0-10%\]") to 5 ("almost always \[91-100%\]"). Higher scores indicate more difficulties in emotion regulation.

  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.

• The Multidimensional Emotional Disorder Inventory (MEDI)

  This is a self-report measure that includes 49 items assessing the main transdiagnostic dimensions of Emotional Disorders: Neurotic Temperament; Positive Temperament; Depressed Mood; Autonomic Arousal; Somatic Anxiety; Social Anxiety; Intrusive Cognitions, Traumatic Re-experiencing; Avoidance. It is responded by a 9-point Likert scale (0=not characteristic of me - 8=extremely characteristic of me). Result for each dimension allows to obtain a profile to emotional disorders.

  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.

• Web-page adherence

  The web automatically records the number of modules completed. At the end of the intervention, the number of modules completed will be analyzed in proportion to the number of modules programmed.

  Post-intervention (11 weeks from pre-intervention assessment).

• Adaptation of the Client Satisfaction Questionnaire (CSQ-8)

  This adaptation is composed of 7 items assessing (a) quality of the intervention and quality of its components, (b) discomfort experienced during treatment, (c) satisfaction with their participation in an online individual format.

  Post-intervention (11 weeks from pre-intervention assessment).

• Unified Protocol Satisfaction questionaire

  It consists of 7 questions that assess the general usefulness of the Unified Protocol to improve emotion regulation skills and the specific usefulness of each of the Unified Protocol skills.

  Post-intervention (11 weeks from pre-intervention assessment).

Study Arms (1)

RE-FER web

EXPERIMENTAL

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).

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Interventions

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders 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.

RE-FER web

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jorge Javier Osma López: lead
• Hospital General Universitario de Castellón: collaborator
• Hospital Universitario La Plana de Castellón: collaborator

Study Sites (1)

Jorge Osma

Teruel, 44003, Spain

Location

MeSH Terms

Conditions

Infertility; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Jorge Osma, PhD

CONTACT

978618101; osma@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking is not applicable in this study as it includes only one condition.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: June 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)