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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade do Porto

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Donor-conceived people

Aged 18 or over

Able to read and understand English

Provide informed consent

Disqualifiers

Not donor-conceived

Underaged ot minor

Unable to read and understand English

Unable to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • MyGENESIS Digital Psychoeducational Program

    Behavioral

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: MyGENESIS InterventionExperimental treatment 1 intervention
Group B: Waitlist Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Perceived stress

Change in perceived stress (PSS-4) total score (range 0-40, higher scores indicating greater perceived stress)

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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Universidade do Porto

Lead sponsor

Fundação para a Ciência e a Tecnologia

Collaborator

This trial is not recruiting at the moment. You can still explore other options: