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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

120

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Universidade do Porto

Collaborators

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)

April 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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