Feasibility Trial of the MyJourney Web App: Supporting Adjustment to an Unfulfilled Wish for Children.

August 2, 2021 updated by: Sofia Gameiro, Cardiff University

Feasibility Randomised Controlled Trial of the MyJourney Web App, Supporting Adjustment to an Unfulfilled Wish for Children.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
221

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Arm
Participants get immediate access to the intervention on completion of baseline assessment.
Other: MyJourney
MyJourney is an online self-help interactive program based on Contextual Cognitive Behavioural Therapy.
No Intervention: Wait list control Arm
Participants get access to the intervention in 10 weeks after completion of the baseline and follow up assessment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of intervention: data directly from web app and survey questions.
Time Frame: Measured at post-intervention (10 weeks)
Measured through website utilization (e.g. number of visits to app, visit duration, number of steps completed, time spent on each step, number of visits to Routines, time spent at each Routine, Routines marked as favourites by users, ratings of usefulness and challenge of each step) and specific questions (developed by researchers).
Measured at post-intervention (10 weeks)
Acceptability of intervention: data directly from web app and survey questions.
Time Frame: Measured at post-intervention (6 months)
Measured through website utilization (e.g. number of visits to app, visit duration, number of steps completed, time spent on each step, number of visits to Routines, time spent at each Routine, Routines marked as favourites by users, ratings of usefulness and challenge of each step) and specific questions (developed by researchers).
Measured at post-intervention (6 months)
Acceptability of study procedures.
Time Frame: Measured at post-intervention (10 weeks)

Measured through specific questions (developed by researchers) to assess acceptability and proportion of completed online surveys.

Reasons for non-participation or withdrawal.
Measured at post-intervention (10 weeks)
Combined demand of intervention and study procedures.
Time Frame: Measured at post-intervention (10 weeks)
Measured with recruitment and attrition rates (including reported reasons for non-participation or withdrawal).
Measured at post-intervention (10 weeks)
Combined demand of intervention and study procedures.
Time Frame: Measured at post-intervention (6 months)
Measured with recruitment and attrition rates (including reported reasons for non-participation or withdrawal).
Measured at post-intervention (6 months)
Implementation of intervention and study procedures reports.
Time Frame: Measured at post-intervention (10 weeks)
Measured with number of reports of inability to access MyJourney or complete steps or any other questions affecting implementation or reports of problems receiving invitations and accessing the online questionnaires.
Measured at post-intervention (10 weeks)
Implementation of intervention and study procedures reports.
Time Frame: Measured at post-intervention (6 months)
Measured with number of reports of inability to access MyJourney or complete steps or any other questions affecting implementation or reports of problems receiving invitations and accessing the online questionnaires.
Measured at post-intervention (6 months)
Practicalities of intervention.
Time Frame: Measured at post-intervention (10 weeks)
Measured with time for participants to work through all steps in intervention.
Measured at post-intervention (10 weeks)
Practicalities of intervention.
Time Frame: Measured at post-intervention (6 months)
Measured with time for participants to work through all steps in intervention.
Measured at post-intervention (6 months)
Practicalities of study procedures.
Time Frame: Measured at post-intervention (10 weeks)
Measured with length of time for researchers to administer (including time taken to send all required reminders and time taken to respond to emails and respond to queries from participants.
Measured at post-intervention (10 weeks)
Practicalities of study procedures.
Time Frame: Measured at post-intervention (6 months)
Measured with length of time for researchers to administer (including time taken to send all required reminders and time taken to respond to emails and respond to queries from participants.
Measured at post-intervention (6 months)
Adaption of study procedures.
Time Frame: Measured at post-intervention (10 weeks)
Measured with reports of different strategies (e.g. dissemination, recruitment, query resolution) required for Portugal (PT) and United Kingdom (UK).
Measured at post-intervention (10 weeks)
Adaption of study procedures.
Time Frame: Measured at post-intervention (6 months)
Measured with reports of different strategies (e.g. dissemination, recruitment, query resolution) required for Portugal (PT) and United Kingdom (UK).
Measured at post-intervention (6 months)
Limited Efficacy Testing - changes from baseline in mental health
Time Frame: From baseline to 10 weeks.
Measured with the Mental Health Inventory-5 (MHI-5; Veit and Ware, 1983). The total scores range from 1 to 100, with higher scores indicating higher mental health.
From baseline to 10 weeks.
Limited Efficacy Testing - changes from baseline in mental health
Time Frame: From baseline to 6 months.
Measured with the Mental Health Inventory-5 (MHI-5; Veit and Ware, 1983). The total scores range from 1 to 100, with higher scores indicating higher mental health.
From baseline to 6 months.
Limited Efficacy Testing - changes from baseline in hedonic wellbeing
Time Frame: From baseline to 10 weeks.
Measured with the World Health Organisation - Five Wellbeing Index (WHO-5; Topp et al., 2015). The total score ranges between 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
From baseline to 10 weeks.
Limited Efficacy Testing - changes from baseline in hedonic wellbeing
Time Frame: From baseline to 6 months.
Measured with the World Health Organisation - Five Wellbeing Index (WHO-5; Topp et al., 2015). The total score ranges between 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
From baseline to 6 months.
Limited Efficacy Testing - changes from baseline in eudaimonic wellbeing
Time Frame: From baseline to 10 weeks.
Measured with the Office of National Statistics eudaimonic subjective well-being scale (Office of National Statistics, 2012). The total scores range between 0 and 10 with higher scores indicating higher eudaimonic wellbeing.
From baseline to 10 weeks.
Limited Efficacy Testing - changes from baseline in eudaimonic wellbeing
Time Frame: From baseline to 6 months.
Measured with the Office of National Statistics eudaimonic subjective well-being scale (Office of National Statistics, 2012). The total scores range between 0 and 10 with higher scores indicating higher eudaimonic wellbeing.
From baseline to 6 months.
Limited Efficacy Testing - changes from baseline in posttraumatic growth
Time Frame: From baseline to 10 weeks.
Measured with the Posttraumatic growth inventory short form (PTG-SF; Cann et al., 2009). The total scores range from 0 to 50, with higher scores indicating higher posttraumatic growth.
From baseline to 10 weeks.
Limited Efficacy Testing - changes from baseline in posttraumatic growth
Time Frame: From baseline to 6 months.
Measured with the Posttraumatic growth inventory short form (PTG-SF; Cann et al., 2009). The total scores range from 0 to 50, with higher scores indicating higher posttraumatic growth.
From baseline to 6 months.
Limited Efficacy Testing - changes from baseline in happiness
Time Frame: From baseline to 10 weeks.
Measured with the single item happiness scale (Ahrendt et al., 2017). The total scores range from 1 to 10, with higher scores indicating higher levels of happiness.
From baseline to 10 weeks.
Limited Efficacy Testing - changes from baseline in happiness
Time Frame: From baseline to 6 months.
Measured with the single item happiness scale (Ahrendt et al., 2017). The total scores range from 1 to 10, with higher scores indicating higher levels of happiness.
From baseline to 6 months.
Limited Efficacy Testing - changes from baseline in satisfaction with life
Time Frame: From baseline to 10 weeks.
Measured with the single item satisfaction with life scale (Ahrendt et al., 2017). The total scores range from 1 to 10, with higher scores indicating higher satisfaction with life.
From baseline to 10 weeks.
Limited Efficacy Testing - changes from baseline in satisfaction with life
Time Frame: From baseline to 6 months.
Measured with the single item satisfaction with life scale (Ahrendt et al., 2017). The total scores range from 1 to 10, with higher scores indicating higher satisfaction with life.
From baseline to 6 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from baseline in acceptance
Time Frame: From baseline to 10 weeks.
Measured with the SCREENIVF Questionnaire (partial) (Verhaak et al., 2010). The total score ranges between 6 to 24, with higher scores indicating higher acceptance.
From baseline to 10 weeks.
Changes from baseline in self-compassion
Time Frame: From baseline to 10 weeks.

Measured with the self-compassion scale short form (SCS-SF; Raes et al., 2011). The total score ranges between 1 and 48, with higher scores indicating higher self-compassion.

Openness to experience subscale-Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT) (Francis et al., 2016)
From baseline to 10 weeks.
Changes from baseline in openness to experience (acceptance and defusion)
Time Frame: From baseline to 10 weeks.
Measured with the Openness to experience subscale-Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT; Francis et al., 2016). The total score ranges from 0 to 70, with higher scores indicating higher openness to experience.
From baseline to 10 weeks.
Changes from baseline in positive reframing coping
Time Frame: From baseline to 10 weeks.

Measured with the Brief COPE Inventory (partial) (Carver, Scheier, & Weintraub, 1989).The total score ranges from 1 to 16, with higher scores indicating higher positive reframing coping.

Motivation and activation subscale-CompACT (Francis et al., 2016)
From baseline to 10 weeks.
Changes from baseline in valued action
Time Frame: From baseline to 10 weeks.
Measured with the Motivation and activation subscale-Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT; Francis et al., 2016). The total score ranges from 0 to 48, with higher scores indicating higher valued action.
From baseline to 10 weeks.
Changes from baseline in goal re-engagement
Time Frame: From baseline to 10 weeks.

Measured with the goal re-engagement scale (Wrosch, Scheier, Carver, & Schulz, 2003). The total score ranges from 6 and 30, with higher scores indicating greater engagement in other meaningful life goals

Committed action scale (CAQ-8) (McCracken, Chilcot, & Norton, 2015)
From baseline to 10 weeks.
Changes from baseline in committed action
Time Frame: From baseline to 10 weeks.
Measured with the Committed action scale (CAQ-8; McCracken, Chilcot, & Norton, 2015). The total score ranges from 0 to 48, with higher scores indicating higher committed action.
From baseline to 10 weeks.
Changes from baseline in social connection
Time Frame: From baseline to 10 weeks.
Measured with the Fertility Problem Inventory - social concern subscale (Newton, Sherrard, & Glavac, 1999). The total score ranges from 1 to 60, with higher scores indicating higher perceived social connection.
From baseline to 10 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardiff University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Portuguese Fertility Association
Fertility Network UK

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beth Rowbottom, School of Psychology, Cardiff University
  • Principal Investigator: Sofia Gameiro, School of Psychology, Cardiff University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC.20.10.13.6082

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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