Psychosocial Stress
Conditions
Keywords
donor-conceived people, donor conception, Psychoeducational intervention, Digital intervention, Cognitive-behavioral training, Stress and coping, Psychological well-being, Randomized controlled trial
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.
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.
Interventions
BEHAVIORALMyGENESIS Digital Psychoeducational Program
A self-guided digital psychoeducational intervention based on cognitive-behavioral principles and the transactional model of stress.
Sponsors
Universidade do Porto
Fundação para a Ciência e a Tecnologia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Donor-conceived people * Aged 18 or over * Able to read and understand English * Provide informed consent
Exclusion criteria
* Previous participation in the MyGENESIS-PATH alpha-testing phase * Unable to provide informed consent * Unable to complete the online study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment feasibility | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived stress | Baseline (pre-intervention) and 4 weeks post-randomization | 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. |
| Psychological well-being | Baseline (pre-intervention) and 4 weeks post-randomization | Change in the WHO well-being index (WHO-5) total score (range 0-40, higher scores indicating greater well-being ) |
| Coping | Baseline (pre-intervention) and 4 weeks post-randomization | 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) |
| Donor-conception identity | Baseline (pre-intervention) and 4 weeks post-randomization | 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. |
Countries
Portugal
Contacts
CONTACTMariana V. Martins, PhD
CONTACTMaria E. Costa, PhD
Outcome results
None listed