An interventional study of MyGENESIS Digital Psychoeducational Program in Psychosocial Stress, sponsored by Universidade do Porto. Not yet recruiting at 1 site in Portugal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Universidade do Porto · Not applicable, Interventional, and Supportive care
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.
MyGENESIS-PATH is a structured, self-guided digital psychoeducational intervention developed as part of the MyGENESIS project. Its development was informed by existing evidence, psychological theory, qualitative and quantitative research with donor-conceived people, and consultation with people with lived experience and relevant professional expertise.
Before the randomized trial, a separate alpha-testing phase will be conducted with donor-conceived adults and expert reviewers to identify major problems relating to comprehensibility, relevance, emotional safety, usability, and technical functioning. Participants involved in alpha testing will not be eligible for the randomized pilot trial.
The registered study is a two-arm, parallel-group randomized pilot and feasibility trial involving 60 donor-conceived adults. After providing informed consent and completing the baseline questionnaire, participants will be randomized automatically within LimeSurvey 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 MyGENESIS-PATH. The intervention comprises six psychoeducational modules, reflective activities, brief self-assessment check-ins, tailored pathways, and conditional coping exercises. Its content addresses:
donor-conception-related information and legal contexts; DNA testing and associated decisions and experiences; donor conception and identity; expectations concerning donors and donor siblings; family relationships, disclosure, support, and stigma; and integration, coping, psychological well-being, and support resources.
Brief check-ins embedded within the intervention are used to tailor coping content to participants' current experiences. Depending on participants' responses, they may receive no additional coping content, a moderate-support exercise, or an elevated-support exercise. Only one level of support is presented for each assessed domain.
Participants will be encouraged to complete the intervention within the access period. Immediately after reaching the end of the intervention, they will be invited to complete a brief feedback questionnaire assessing acceptability, usability, usefulness, relevance, emotional manageability, technical problems, and potential unwanted effects.
Participants allocated to the waitlist control group will not receive access to MyGENESIS-PATH during the initial study period. Both groups will complete psychosocial outcome assessments at baseline and 4 weeks after randomization. Waitlist participants will be offered access to MyGENESIS-PATH after completing the 4-week follow-up assessment.
The study will primarily assess the feasibility and acceptability of recruitment, randomization, intervention delivery and use, immediate feedback collection, participant follow-up, and psychosocial outcome-data collection. Psychological outcomes will be examined descriptively and exploratorily to assess their suitability, variability, and potential responsiveness for a future definitive trial.
Exclusion Criteria:
Participants randomized to this arm receive access to the MyGENESIS digital psychoeducational program, consisting of six sequential self-guided online modules.
Behavioral: MyGENESIS Digital Psychoeducational Program
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.
A self-guided digital psychoeducational intervention based on cognitive-behavioral principles and the transactional model of stress.
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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks after randomization
Perceived stress
Change in perceived stress as measured by the Perceived Stress Scale (PSS-4) total score (range 0-16), with higher scores indicating greater perceived stress.
Time frame: Baseline (pre-intervention) and 4 weeks post-randomization
Psychological well-being
Change in the WHO well-being index (WHO-5) total score (range 0-40, higher scores indicating greater well-being )
Time frame: 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)
Time frame: 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.
Time frame: Baseline (pre-intervention) and 4 weeks post-randomization
Plan to share: Yes — 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.
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Universidade do Porto