MyGENESIS-PATH: Digital Program for Donor-Conceived People

NCT07457697 | Not Yet Recruiting

• 1 other identifier: 2023.14465.PEX
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

MyGENESIS-PATH is a self-guided digital psychoeducational intervention designed to support donor-conceived adults in navigating donor-conception-related information and uncertainty, DNA testing, identity, family relationships, disclosure, stigma, and expectations concerning donors and donor siblings. This two-arm 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 condition. Primary feasibility outcomes will assess recruitment, completion of the 4-week follow-up assessment, completeness of psychosocial outcome data, intervention uptake and completion, and completion of the immediate post-intervention feedback assessment. Intervention acceptability, usability, perceived usefulness, relevance, emotional manageability, and potential unwanted effects will be assessed among participants allocated to MyGENESIS-PATH. Changes in perceived stress, psychological well-being, coping, and donor-conception-related identity from baseline to 4 weeks after randomization will be examined as exploratory outcomes. The study is not powered to detect definitive intervention effects.

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 (3)

• Recruitment feasibility

  Number of eligible participants who provide informed consent, complete the baseline questionnaire, and are randomized during the planned recruitment period. The recruitment target is 60 randomized participants within the planned recruitment period. The number screened, number eligible, number consenting, number completing baseline, and mean number randomized per month will also be reported.

  From recruitment opening to completion of recruitment, anticipated to be approximately 3 months

• Acceptability of MyGENESIS-PATH

  Acceptability will be assessed immediately after intervention completion among participants allocated to MyGENESIS-PATH using participant ratings of perceived usefulness; perceived relevance; emotional manageability; willingness to recommend the intervention to another donor-conceived person. Acceptability will also be explored qualitatively through optional open-ended feedback.

  Immediately after completing the intervention.

• Completion of the 4-week follow-up assessment

  Percentage of all randomized participants who submit the 4-week follow-up questionnaire. The numerator will be the number of randomized participants submitting the follow-up questionnaire, and the denominator will be all randomized participants. A completion rate of at least 80% will support progression without major modification.

  4 weeks after randomization

Secondary Outcomes (3)

• Psychological well-being

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

• Coping

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

• Donor-conception 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:

• Previous participation in the MyGENESIS-PATH alpha-testing phase
• Unable to provide informed consent
• Unable to complete the online study procedures

Sponsors & Collaborators

• Universidade do Porto: lead
• Fundação para a Ciência e a Tecnologia: 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. Participants will know whether they have immediate access to MyGENESIS-PATH. The research team will also have access to group allocation where required for intervention administration and follow-up. Outcomes will be assessed using self-administered online questionnaires. No blinded outcome assessor is involved.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study uses a two-arm, parallel-group randomized pilot and feasibility design. After completing the baseline questionnaire, participants will be automatically randomized within the online platform in a 1:1 ratio to immediate access to MyGENESIS-PATH (IG) or to a waitlist control condition. Participants allocated to the IG will receive access to a self-guided digital psychoeducational intervention comprising six sequential modules, personalised pathways, reflective activities, brief check-ins, and tailored coping exercises. Participants allocated to the CG will not receive access during the initial 4-week study period (access after completing the 4-week follow-up assessment). IG participants will complete a brief feedback assessment immediately after reaching the end of MyGENESIS-PATH. Psychosocial outcomes will be assessed in both groups at baseline and 4 weeks after randomization. This pilot and feasibility study is not powered to detect definitive intervention effects.

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: March 9, 2026
• Study Start (Estimated): August 18, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

PT (1)