P-495 A feasibility randomised controlled trial of MyJourney: a self-guided online intervention to promote psychosocial adjustment to unmet parenthood goals

Abstract

Abstract Study question Is it feasible to implement and evaluate an online self-guided psychosocial intervention for people with unmet parenthood goals (UPG), aimed to improve wellbeing, in an online randomized controlled trial (RCT)? Summary answer The evaluation of an online bilingual self-guided psychosocial intervention for people with a UPG is feasible but minor adjustments should be made to enhance practicality. What is known already Self-identifying as having a UPG, defined as being unable to have children or as many as desired, is associated with impaired wellbeing and mental health. Practice guidelines and regulatory bodies have highlighted the need to address the lack of evidence-based support for this population. It is unknown if MyJourney (www.myjourney.pt), the first online self-guided intervention for people with UPGs, can be implemented and evaluated in an RCT. Study design, size, duration We conducted a pre-registered, two-arm, parallel group, non-blinded feasibility RCT, with a 1:1 computer-generated randomised allocation and embedded qualitative process evaluation. Recruitment run from November 2020 to March 2021. Assessments were made before randomisation (T1), 10-weeks (T2) and 6-months after (T3, intervention group only). Participants allocated to the intervention group received an email to access MyJourney immediately after randomization. Participants in the control group were given access to MyJourney after filling the 10-weeks assessment (T2). Participants/materials, setting, methods Participants were recruited via social media advertising of MyJourney and its feasibility study. People who self-identified as having a UPG could click on a link to participate and of these 235 were randomised. Outcome measures related to demand, acceptability, implementation, practicality, adaptation, and limited efficacy were assessed via online surveys. The primary outcome in limited efficacy testing was hedonic wellbeing, measured with the World Health Organisation Wellbeing Index (WHO-5). Main results and the role of chance Participation and retention rates were 58.3%, 31.7% (T2) and 45.2% (T3, intervention group only). Of participants invited to register with MyJourney, 91 (76.5%) set up account, 51 (47.2%) completed the first Step of MyJourney, 12 (11.1%) completed six Steps (sufficient dose) and six (5.6%) completed all Steps within the 10-week recommended period. Acceptability ranged from 2.79 (successful at supporting) to 4.42 (easy to understand) on a 1(not at all) to 5(extremely acceptable). Average time to complete sufficient dose was 5.6 hours (SD = 18.15) and all Steps was 12.4 hours (SD = 18.15), with no differences found for participants using MyJourney in Portuguese and English. Modified intention to treat analysis showed a moderate increase in wellbeing from T1 to T2 in the intervention group (ηp2 = .156, MD = 9.300 [2.285, 16.315]) and no changes in the control group (ηp2 = .000, MD = .047 [-3.265, 3.358]). Participants in the process evaluation reported that MyJourney was needed and answered their needs for support (reflecting high demand and acceptability). Participants thought the recommended period to engage with MyJourney was short and that their engagement was influenced by multiple factors, including personal (e.g., lack of time) and MyJourney related factors (e.g., reminders). Limitations, reasons for caution Participants were mostly white, well-educated, employed, childless women. Non-blinded allocation, use of self-reported questionnaire assessments and high attrition in the intervention group could have triggered bias favourable to positive evaluations MyJourney. Wider implications of the findings MyJourney can proceed to efficacy testing, but future work should eliminate barriers for engagement (e.g., enabling users to add MyJourney icon to device and remain logged in) and explore strategies to maximise adherence (e.g., reminders with personalised content, guidance and scheduling options for routine use). Trial registration number Clinical Trials.gov NCT04850482