MyGENESIS-PATH: A Pilot and Feasibility Trial of a Digital Intervention for Donor-Conceived Adults (MyGENESIS-Path)

A Randomized Pilot and Feasibility Trial of MyGENESIS-PATH, a Digital Psychoeducational Intervention for Donor-Conceived Adults

MyGENESIS-PATH is a self-guided digital psychoeducational intervention designed to support donor-conceived adults in managing stress and navigating identity, information, family, DNA-testing, and donor- or sibling-contact-related experiences.

This randomized pilot and feasibility trial will evaluate the feasibility and acceptability of delivering MyGENESIS-PATH and of conducting a future definitive randomized controlled trial. Sixty donor-conceived adults will be randomly allocated in a 1:1 ratio to immediate access to MyGENESIS-PATH or to a waitlist control group. The primary objectives are to assess recruitment, retention, intervention uptake and completion, data completeness, acceptability, usability, and potential unwanted effects. Changes in perceived stress, psychological wellbeing, coping, and donor-conception-related identity will be explored to assess the suitability and variability of outcome measures and to inform the design of a future trial.

Study Overview

• Status: Not yet recruiting
• Conditions: Psychosocial Stress
• Intervention / Treatment: Behavioral: MyGENESIS Digital Psychoeducational Program

Detailed Description

MyGENESIS-PATH was developed as part of the MyGENESIS project using evidence, psychological theory, and input from donor-conceived people. Before the randomized trial, a separate alpha-testing phase will be conducted with a small group of donor-conceived adults and expert reviewers to identify major usability, comprehensibility, acceptability, technical, and safety concerns. Alpha-testing participants will not participate in the randomized trial.

The registered study is a two-arm randomized pilot and feasibility trial involving 60 donor-conceived adults. After baseline assessment, participants will be randomly allocated in a 1:1 ratio to immediate access to MyGENESIS-PATH or to a waitlist control condition.

Participants allocated to the intervention group will receive access to the self-guided digital intervention for four weeks. The intervention comprises psychoeducational modules, reflective activities, brief check-ins, and tailored coping exercises addressing donor-conception-related information and uncertainty, DNA testing, identity, expectations concerning donors and donor siblings, family relationships, disclosure, stigma, coping, and psychological wellbeing.

Participants allocated to the waitlist control group will complete the same baseline and four-week assessments and will receive access to the intervention after completing the follow-up assessment.

The study will primarily assess the feasibility and acceptability of recruitment, randomization, intervention delivery, intervention use, participant retention, and outcome-data collection. Psychological outcomes will be examined descriptively and exploratorily.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariana V. Martins, PhD; Phone Number: +351 220 400 667; Email: mmartins@fpce.up.pt
• Study Contact Backup: Name: Maria E. Costa, PhD; Phone Number: +351 220 400 667; Email: ecosta@fpce.up.pt

Study Locations

• Portugal
  • Porto District
    • Porto, Porto District, Portugal, 4200
      • Faculty of Psychology and Education Sciences, University of Porto
      • Contact: Research management officer, PhD; Phone Number: 388 226079700; Email: tgouveia@fpce.up.pt

Participation Criteria

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
• Underaged ot minor
• Unable to read and understand English
• Unable to provide informed consent
• Inability to complete online questionnaires / lack of internet access

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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
Perceived stress	Change in perceived stress (PSS-4) total score (range 0-40, higher scores indicating greater perceived stress)	Baseline (pre-intervention) and 4 weeks post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological well-being	Change in the WHO well-being index (WHO-5) total score (range 0-40, higher scores indicating greater well-being )	Baseline (pre-intervention) and 4 weeks post-randomization
Coping	Change in coping responses as measured by the Brief COPE Inventory subscale scores (14 subscales, each ranging from 2-8, with higher scores indicating greater use of the respective coping strategy)	Baseline (pre-intervention) and 4 weeks post-randomization
Donor-conception identity	Change in donor conception identity as measured by the Donor Conception Identity Questionnaire (DCIQ) subscale scores, including Concern and Preoccupation (range 8-40), Internalized Stigma (range 5-25), Pride and Acceptance (range 6-30), and Openness and Understanding (range 4-20) Higher scores indicate greater endorsement of the respective donor conception identity domain.	Baseline (pre-intervention) and 4 weeks post-randomization

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Fundação para a Ciência e a Tecnologia

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 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): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Psychoeducational intervention; Psychological well-being; Digital intervention; Stress and coping; donor-conceived people; donor conception; Cognitive-behavioral training
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• 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