InfertilityRE-FER moodleNCT06420674
Online Prevention of Emotional Disorders in Women Undergoing Fertility Treatments
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Infertility and Emotional Disorder, run by Jorge Javier Osma López at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility, Emotional Disorder, Anxiety Depression
- What is being tested?
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not having Internet access to access the web-page.
- Having a diagnosis of severe mental disorder.
- Active suicidal ideation at the time of evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online Prevention of Emotional Disorders in Women Undergoing Fertility Treatments (RE-FER Moodle)
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:
- 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.
- 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.
Read the 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.
- Conditions
- Infertility, Emotional Disorder, Anxiety Depression
- Being tested
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Keywords
- Unified Protocol, Prevention, Anxiety, Depression, Reproduction
- Medical subject headings
- Infertility, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for Transdiagnostic Treatment of Emotional DisordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (11 weeks from pre-intervention assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will be offered to all women undergoing artificial inseminations in two public hospitals.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jorge Javier Osma López
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario de Castellón, Hospital Universitario La Plana de Castellón
- Responsible party
- Sponsor-investigator, Jorge Javier Osma López, Instituto de Investigación Sanitaria Aragón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420674
- Sponsor's protocol ID
- IPES/RE-FER/moodle
- Acronym
- RE-FER moodle
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Prevention of Emotional Disorders in Women Undergoing Fertility Treatments (RE-FER Moodle)
- ClinicalTrials.gov ID
- NCT06420674
- Acronym / sponsor ID
- RE-FER moodle / IPES/RE-FER/moodle
- Conditions
- Infertility, Emotional Disorder, Anxiety Depression
- Keywords
- Unified Protocol, Prevention, Anxiety, Depression, Reproduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jorge Javier Osma LópezUniversity, hospital or other
- Collaborators
- Hospital General Universitario de Castellón, Hospital Universitario La Plana de Castellón
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will be offered to all women undergoing artificial inseminations in two public hospitals.
| Arm | Type | Receives |
|---|---|---|
| RE-FER web | Experimental | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Not having Internet access to access the web-page.
- Having a diagnosis of severe mental disorder.
- Active suicidal ideation at the time of evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified Protocol for Transdiagnostic Treatment of Emotional DisordersThe 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. | Behavioural | RE-FER web |
Primary outcome
Overall Depression Severity and Impairment Scale (ODSIS)
Time frame: 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.
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.
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: 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.
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.
Fertility Problem Inventory (FPI)
Time frame: 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.
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.
Fertility Quality of Life Questionnaire (FertiQoL)
Time frame: 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.
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.
Difficulties in Emotion Regulation Scale (DERS)
Time frame: 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.
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.
The Multidimensional Emotional Disorder Inventory (MEDI)
Time frame: 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.
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.
Web-page adherence
Time frame: Post-intervention (11 weeks from pre-intervention assessment).
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.
Adaptation of the Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post-intervention (11 weeks from pre-intervention assessment).
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.
Unified Protocol Satisfaction questionaire
Time frame: Post-intervention (11 weeks from pre-intervention assessment).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Infertility and Emotional Disorder, run by Jorge Javier Osma López at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Osma, PhD (978618101 ext. +34, osma@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Depression Severity and Impairment Scale (ODSIS) (time frame: 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 study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.