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

NCT07457697 | Not Yet Recruiting

• 1 other identifier: 2023.14465.PEX
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychosocial Stress

Keywords

donor-conceived people; donor conception; Psychoeducational intervention; Digital intervention; Cognitive-behavioral training; Stress and coping; Psychological well-being; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• stress

  Change in perceived stress as measured by the Perceived Stress Scale (PSS-10) total score

  Baseline (pre-intervention) and 4 weeks post-randomization

Secondary Outcomes (3)

• coping

  Baseline (pre-intervention) and 4 weeks post-randomization

• Psychological well-being

  Baseline (pre-intervention) and 4 weeks post-randomization

• donor-conceived related identity

  Baseline (pre-intervention) and 4 weeks post-randomization

Study Arms (2)

MyGENESIS Intervention

EXPERIMENTAL

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

Waitlist Control Group

NO INTERVENTION

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.

Interventions

MyGENESIS Digital Psychoeducational Program BEHAVIORAL

A self-guided digital psychoeducational intervention based on cognitive-behavioral principles and the transactional model of stress.

MyGENESIS Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Faculdade de Psicologia e de Ciências de Educação da Universidade do Porto: collaborator

Study Sites (1)

Faculty of Psychology and Education Sciences, University of Porto

Porto, Porto District, 4200, Portugal

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Mariana V. Martins, PhD

CONTACT

+351 220 400 667; mmartins@fpce.up.pt

Maria E. Costa, PhD

CONTACT

+351 220 400 667; ecosta@fpce.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Due to the nature of the self-guided digital psychoeducational intervention, participants are aware of whether they have access to the intervention during the study period. Investigators and study personnel are not masked to allocation. Outcomes are assessed using self-report online questionnaires.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study uses a parallel-group randomized controlled design. Eligible donor-conceived participants are randomly assigned to either the Genesis intervention group or a control group. Participants allocated to the intervention group receive access to a self-guided digital psychoeducational program consisting of five sequential modules that must be completed in a fixed order. Participants in the control group do not receive access to the intervention during the study period. Outcomes are assessed at baseline and post-intervention.

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: March 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

PT (1)