Psychosocial StressMyGENESIS-PathNCT07457697
MyGENESIS-PATH: Digital Program for Donor-Conceived People
A study testing MyGENESIS Digital Psychoeducational Program in people with Psychosocial Stress, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Stress
- What is being tested?
- MyGENESIS Digital Psychoeducational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 18 Aug 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Donor-conceived people
- Aged 18 or over
- Able to read and understand English
- Provide informed consent
Who cannot join
- Previous participation in the MyGENESIS-PATH alpha-testing phase
- Unable to provide informed consent
- Unable to complete the online study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Faculty of Psychology and Education Sciences, University of Porto
Porto, Porto District, 4200
Research management officer, PhD, 226079700 ext. 388, tgouveia@fpce.up.pt
About this study
Official title: A Randomized Pilot and Feasibility Trial of a Digital Psychoeducational Intervention for Donor-Conceived Adults (MyGENESIS-PATH)
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Psychosocial Stress
- Being tested
- MyGENESIS Digital Psychoeducational Program
- Keywords
- donor-conceived people, donor conception, Psychoeducational intervention, Digital intervention, Cognitive-behavioral training, Stress and coping, Psychological well-being, Randomized controlled trial
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyGENESIS Digital Psychoeducational ProgramBehavioural
A self-guided digital psychoeducational intervention based on cognitive-behavioral principles and the transactional model of stress.
| Study group | Role | What they receive |
|---|---|---|
| MyGENESIS Intervention | Experimental | Participants randomized to this arm receive access to the MyGENESIS digital psychoeducational program, consisting of six sequential self-guided online modules. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks after randomization
Secondary outcomes (4)
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.
Measured: 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 )
Measured: 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)
Measured: 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.
Measured: Baseline (pre-intervention) and 4 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start18 Aug 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Mariana Veloso Martins, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457697
- Sponsor's protocol ID
- 2023.14465.PEX
- Other IDs
- 2023.14465.PEX, 2023
- Acronym
- MyGENESIS-Path
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot and Feasibility Trial of a Digital Psychoeducational Intervention for Donor-Conceived Adults (MyGENESIS-PATH)
- ClinicalTrials.gov ID
- NCT07457697
- Acronym / sponsor ID
- MyGENESIS-Path / 2023.14465.PEX
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 18 Aug 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MyGENESIS Intervention | Experimental | Behavioral: MyGENESIS Digital Psychoeducational ProgramParticipants randomized to this arm receive access to the MyGENESIS digital psychoeducational program, consisting of six sequential self-guided online modules. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Donor-conceived people
- Aged 18 or over
- Able to read and understand English
- Provide informed consent
Key exclusion criteria (3 listed)
- Previous participation in the MyGENESIS-PATH alpha-testing phase
- Unable to provide informed consent
- Unable to complete the online study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyGENESIS Digital Psychoeducational ProgramA self-guided digital psychoeducational intervention based on cognitive-behavioral principles and the transactional model of stress. | Behavioural | MyGENESIS Intervention |
Primary outcome
Recruitment feasibility
Time frame: From recruitment opening to completion of recruitment, anticipated to be approximately 3 months
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.
Acceptability of MyGENESIS-PATH
Time frame: Immediately after completing the intervention.
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.
Completion of the 4-week follow-up assessment
Time frame: 4 weeks after randomization
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 secondary outcomes
Perceived stress
Time frame: Baseline (pre-intervention) and 4 weeks post-randomization
Psychological well-being
Time frame: Baseline (pre-intervention) and 4 weeks post-randomization
Coping
Time frame: Baseline (pre-intervention) and 4 weeks post-randomization
Donor-conception identity
Time frame: Baseline (pre-intervention) and 4 weeks post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyGENESIS Digital Psychoeducational Program in people with Psychosocial Stress, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana V. Martins, PhD (+351 220 400 667, mmartins@fpce.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: From recruitment opening to completion of recruitment, anticipated to be approximately 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.