MyGENESIS: A Digital Psychoeducational Program for Donor-Conceived Young Adults (MyGENESIS)

March 3, 2026 updated by: Mariana Veloso Martins, Universidade do Porto

Effectiveness of a Digital Psychoeducational Intervention (MyGENESIS) for Donor-Conceived Young Adults: A Randomized Controlled Trial

This randomized controlled trial evaluates the effectiveness of MyGENESIS, a self-guided digital psychoeducational intervention designed for donor-conceived people aged >17 years.

MyGENESIS is grounded in cognitive-behavioral principles and the transactional model of stress and aims to support participants in understanding donor conception, managing stress, developing adaptive coping strategies, and addressing cognitive appraisals related to their donor-conceived status.

Participants will be randomly assigned to either the intervention group or a control condition. Outcomes related to psychological well-being, stress, and coping will be assessed at baseline and post-intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

MyGENESIS is a structured, self-guided digital psychoeducational intervention developed through a participatory research approach with donor-conceived people. The intervention integrates cognitive-behavioral training with the transactional model of stress, emphasizing the role of cognitive appraisals and coping strategies in psychological adjustment.

The intervention consists of five sequential modules:

  1. psychoeducation on donor conception and its implications;
  2. stress, coping, and emotion regulation;
  3. cognitive restructuring;
  4. problem-solving strategies;
  5. review of stress responses and future goal setting.

The trial adopts a randomized controlled design to evaluate the effectiveness of Genesis in improving stress management and psychological adjustment among donor-conceived adults.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Portugal
    • Porto District
      • Porto, Porto District, Portugal, 4200
        • Faculty of Psychology and Education Sciences, University of Porto
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Donor-conceived people
  • Aged 18 or over
  • Able to read and understand English
  • Provide informed consent

Exclusion Criteria:

  • Not donor-conceived
  • Outside the age range (18-35 years)
  • Unable to read and understand English
  • Unable to provide informed consent
  • Inability to complete online questionnaires / lack of internet access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MyGENESIS Intervention
Participants randomized to this arm receive access to the MyGENESIS digital psychoeducational program, consisting of five sequential self-guided online modules.
Behavioral: MyGENESIS Digital Psychoeducational Program
A self-guided digital psychoeducational intervention based on cognitive-behavioral principles and the transactional model of stress.
No Intervention: Waitlist Control Group
Participants in this arm do not receive access to the MyGENESIS intervention during the study period and are offered access after completion of post-test assessments.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
stress
Time Frame: Baseline (pre-intervention) and 4 weeks post-randomization
Change in perceived stress as measured by the Perceived Stress Scale (PSS-10) total score
Baseline (pre-intervention) and 4 weeks post-randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
coping
Time Frame: Baseline (pre-intervention) and 4 weeks post-randomization
Change in coping strategies as measured by the Brief COPE total and subscale scores
Baseline (pre-intervention) and 4 weeks post-randomization
Psychological well-being
Time Frame: Baseline (pre-intervention) and 4 weeks post-randomization
Change in psychological well-being as measured by the WHO-5 Well-Being Index total score
Baseline (pre-intervention) and 4 weeks post-randomization
donor-conceived related identity
Time Frame: Baseline (pre-intervention) and 4 weeks post-randomization
Change in donor-conceived related identity as measured by the Donor Conception Identity Questionnaire
Baseline (pre-intervention) and 4 weeks post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade do Porto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação para a Ciência e a Tecnologia
Faculdade de Psicologia e de Ciências de Educação da Universidade do Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023.14465.PEX (Other Grant/Funding Number: Portuguese Science and Technology Foundation (FCT, Fundação para a Ciência e Tecnologia))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data and supporting documentation (study protocol, statistical analysis plan, and informed consent form template) will be made available upon reasonable request to the principal investigator following publication of the primary results. Requests will be reviewed by the research team and will require a data sharing agreement and confirmation of ethical approval where applicable.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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