Clinical trial NCT04850482: Feasibility Trial of the MyJourney Web App: Supporting Adjustment to an Unfulfilled Wish for Children.
Official title: Feasibility Randomised Controlled Trial of the MyJourney Web App, Supporting Adjustment to an Unfulfilled Wish for Children.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health
Keywords: Well being
Unfulfilled wish for children
Self-Help
Online intervention
Involuntary childlessness
Lead sponsor: Cardiff University
Sponsor class: OTHER
Collaborators: name: Portuguese Fertility Association
name: Fertility Network UK
First posted: 2021-04-20
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm, parallel-group, non-blind feasibility trial with 1:1 allocation to the intervention group (immediate access to MyJourney) or waitlist control group (receives access to MyJourney after 10 weeks).
Primary purpose: SUPPORTIVE_CARE

Brief summary: A bilingual online self-help app - MyJourney - has been developed for individuals faced with an unfulfilled wish for children. The specific aim of this trial is to evaluate the feasibility, defined here as determining whether the intervention itself and the study procedures are appropriate for further evaluation, and how users react to the intervention, which will inform the implementation of a future full scale RCT to evaluate MyJourney's efficacy.

This RCT will be a two arm, parallel-group, non-blind feasibility trial with 1:1 allocation to the intervention group (immediate access to MyJourney) or waitlist control group (receives access to MyJourney after 10 weeks). A minimum number of 152 individuals will be enrolled in this study. Once participants have met the eligibility criteria and completed the baseline assessment, they will be randomly assigned to one of two groups: the intervention group or the waitlist control group. The sample will be recruited online.

Participation in this study will last 10 weeks for the waitlist group and 6 months for the intervention group. Participants in both groups will be invited to complete a baseline assessment (online survey) and a follow-up assessment (online survey) at 10-weeks post baseline. The intervention group will also be invited to complete another follow-up assessment at 6-months post baseline. Assessments will include self-report questionnaires to cover socio-demographic information (baseline only), psychological mediators (mechanisms of change) (baseline and 10-week follow-up), psychological outcome questionnaires (baseline, 10-week and 6-month follow up), and questions about acceptability and feasibility (10-week and 6-month follow up).

Detailed description: In this trial, a bilingual self-help web-app, MyJourney, developed to support individuals with an unfulfilled wish for children, will be evaluated for feasibility. This trial forms part of the exploratory trial phase of development of complex interventions, based on guidance from the Medical Research Council.

Although research has demonstrated that those faced with an unfulfilled wish for children (i.e., the inability to have all the children desired) can experience intense grief and worse mental health for a prolonged period, at present there is limited evidence for a theory led intervention that would provide support for this group and to date there is no widely used evidence-based interventions for individuals facing an unfulfilled wish for children. An in-depth systematic review of how people adjust to an unfulfilled wish for children informed the Three Task Model (3TM). This proposes three psychological mechanisms that facilitate adjustment to an unfulfilled wish for children: acceptance, meaning making and pursuit of new life goals, leading to better mental-health and well-being.

Therefore, a bilingual online self-help web app - MyJourney - was developed. The 3TM informed the hypothesised mechanisms of the change targeted by the intervention. Contextual Cognitive Behavioural Therapy (CCBT) was chosen as the therapeutic framework for each of the steps within the intervention, focussing on a person's relationships with their thoughts, emotions and behaviours. The intervention consists of 10 ordered Steps. Each Step is a structured therapeutic activity designed to activate a specific technique which is linked to the theorized mechanism of change. Each Step has up to three optional therapeutic resources designed to encourage participants to engage with and practice the therapeutic skill they are developing. Users are invited to engage with one Step per week over 10 weeks, however they are able to engage at their own pace.

The specific aim of this trial is to evaluate feasibility, defined here as determining whether the intervention itself and the study procedures are appropriate for further evaluation, and how users react to the intervention, which will inform the implementation of a future full scale RCT to evaluate MyJourney's efficacy. Several feasibility outcomes will be focussed on, including acceptability, demand, implementation, practicality, adaption, and limited efficacy testing. In addition, the targeted mechanisms of change will also be evaluated.

This RCT will be a two arm, parallel-group, non-blind feasibility trial with 1:1 allocation to the intervention group (immediate access to MyJourney) or waitlist control group (receives access to MyJourney after 10 weeks). There will be three assessment moments: one at baseline (pre-exposure to intervention); 10 weeks after baseline (post exposure to intervention); and 6 months after baseline (intervention group only).

Participants will be recruited via appropriate websites, social media, blogs, via direct contact with appropriate support groups and Prolific. A minimum of 50 participants will be required, and accounting for participation and attrition rates, a minimum of 152 individuals need to be recruited.

Participants will be directed to https://myjourney.pt from the trial advertisements and upon clicking 'Get Started' will be informed of the trial goals, structure and participant roles. Individuals who decided to take part in the trial will be provided with an information sheet and they will then give their informed consent. One they have indicated their eligibility and completed the baseline assessment (socio-demographic details, psychological mediators and outcomes), they will be randomly assigned to the intervention group or the waitlist control group. The participants assigned to the waitlist control will be informed that they are on a waiting-list and that they will receive access to the MyJourney in 10 weeks. The participants in the intervention group will be provided with a link to register to MyJourney.

Ten weeks after completion of the baseline assessment, participants in the intervention and waitlist control groups will be invited to complete a follow up assessment. The ten-week follow-up assessment will ask participants to report on psychological mediators and outcomes and the intervention group will complete a section on acceptability of MyJourney. At the end of completing this assessment, participants in the waitlist control group will be provided with a debrief form and given access to MyJourney. Six months after baseline, participants in the intervention group (only) will be invited to complete another follow up assessment covering only psychological outcomes, at the end of which they will be provided with a debrief form. Some participants will also take part in an interview as part of the study's process evaluation.

Eligibility criteria: Inclusion Criteria:

* able to provide consent
* self-identifying as having an unfulfilled wish for children
* being able to use and access MyJourney (have an internet connection, suitable device and have an active email address)
* speak English or Portuguese
* be able to fill out online questionnaires

Exclusion Criteria:

* diagnosed with a mental-health disorder within the last 2 years \[self-reported\]
* currently receiving therapy for a clinically diagnosed mental-health disorder
* individual or group therapy or peer support specifically related to their unfulfilled wish for children \[self-reported\]
* unable to use MyJourney due to other health problems (e.g., vision impairments)

Primary outcomes:
measure: Acceptability of intervention: data directly from web app and survey questions.
timeFrame: Measured at post-intervention (10 weeks)
measure: Acceptability of intervention: data directly from web app and survey questions.
timeFrame: Measured at post-intervention (6 months)
measure: Acceptability of study procedures.
timeFrame: Measured at post-intervention (10 weeks)
measure: Combined demand of intervention and study procedures.
timeFrame: Measured at post-intervention (10 weeks)
measure: Combined demand of intervention and study procedures.
timeFrame: Measured at post-intervention (6 months)
measure: Implementation of intervention and study procedures reports.
timeFrame: Measured at post-intervention (10 weeks)
measure: Implementation of intervention and study procedures reports.
timeFrame: Measured at post-intervention (6 months)
measure: Practicalities of intervention.
timeFrame: Measured at post-intervention (10 weeks)
measure: Practicalities of intervention.
timeFrame: Measured at post-intervention (6 months)
measure: Practicalities of study procedures.
timeFrame: Measured at post-intervention (10 weeks)
measure: Practicalities of study procedures.
timeFrame: Measured at post-intervention (6 months)
measure: Adaption of study procedures.
timeFrame: Measured at post-intervention (10 weeks)
measure: Adaption of study procedures.
timeFrame: Measured at post-intervention (6 months)
measure: Limited Efficacy Testing - changes from baseline in mental health
timeFrame: From baseline to 10 weeks.
measure: Limited Efficacy Testing - changes from baseline in mental health
timeFrame: From baseline to 6 months.
measure: Limited Efficacy Testing - changes from baseline in hedonic wellbeing
timeFrame: From baseline to 10 weeks.
measure: Limited Efficacy Testing - changes from baseline in hedonic wellbeing
timeFrame: From baseline to 6 months.
measure: Limited Efficacy Testing - changes from baseline in eudaimonic wellbeing
timeFrame: From baseline to 10 weeks.
measure: Limited Efficacy Testing - changes from baseline in eudaimonic wellbeing
timeFrame: From baseline to 6 months.
measure: Limited Efficacy Testing - changes from baseline in posttraumatic growth
timeFrame: From baseline to 10 weeks.
measure: Limited Efficacy Testing - changes from baseline in posttraumatic growth
timeFrame: From baseline to 6 months.
measure: Limited Efficacy Testing - changes from baseline in happiness
timeFrame: From baseline to 10 weeks.
measure: Limited Efficacy Testing - changes from baseline in happiness
timeFrame: From baseline to 6 months.
measure: Limited Efficacy Testing - changes from baseline in satisfaction with life
timeFrame: From baseline to 10 weeks.
measure: Limited Efficacy Testing - changes from baseline in satisfaction with life
timeFrame: From baseline to 6 months.
Secondary outcomes:
measure: Changes from baseline in acceptance
timeFrame: From baseline to 10 weeks.
measure: Changes from baseline in self-compassion
timeFrame: From baseline to 10 weeks.
measure: Changes from baseline in openness to experience (acceptance and defusion)
timeFrame: From baseline to 10 weeks.
measure: Changes from baseline in positive reframing coping
timeFrame: From baseline to 10 weeks.
measure: Changes from baseline in valued action
timeFrame: From baseline to 10 weeks.
measure: Changes from baseline in goal re-engagement
timeFrame: From baseline to 10 weeks.
measure: Changes from baseline in committed action
timeFrame: From baseline to 10 weeks.
measure: Changes from baseline in social connection
timeFrame: From baseline to 10 weeks.
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Cardiff University
Study officials:
affiliation: School of Psychology, Cardiff University
name: Beth Rowbottom
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Psychology, Cardiff University
name: Sofia Gameiro
role: PRINCIPAL_INVESTIGATOR
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citation: Rowbottom B, Galhardo A, Donovan E, Gameiro S. Feasibility randomized controlled trial of a self-guided online intervention to promote psychosocial adjustment to unmet parenthood goals. Hum Reprod. 2022 Sep 30;37(10):2412-2425. doi: 10.1093/humrep/deac168.