Mental HealthNCT04850482
Feasibility Trial of the MyJourney Web App: Supporting Adjustment to an Unfulfilled Wish for Children.
A study testing MyJourney in people with Mental Health, run by Cardiff University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- MyJourney
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Mental Health
- Being tested
- MyJourney
- Keywords
- Well being, Unfulfilled wish for children, Self-Help, Online intervention, Involuntary childlessness
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyJourneyOther
MyJourney is an online self-help interactive program based on Contextual Cognitive Behavioural Therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants get immediate access to the intervention on completion of baseline assessment. Receives: Other: MyJourney |
| Wait list control Arm | No intervention | Participants get access to the intervention in 10 weeks after completion of the baseline and follow up assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of intervention: data directly from web app and survey questions.
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: Measured at post-intervention (10 weeks)
Acceptability of intervention: data directly from web app and survey questions.
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: Measured at post-intervention (6 months)
Acceptability of study procedures.
Measured through specific questions (developed by researchers) to assess acceptability and proportion of completed online surveys.
Reasons for non-participation or withdrawal.
Measured: Measured at post-intervention (10 weeks)
Combined demand of intervention and study procedures.
Measured with recruitment and attrition rates (including reported reasons for non-participation or withdrawal).
Measured: Measured at post-intervention (10 weeks)
Combined demand of intervention and study procedures.
Measured with recruitment and attrition rates (including reported reasons for non-participation or withdrawal).
Measured: Measured at post-intervention (6 months)
Implementation of intervention and study procedures reports.
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: Measured at post-intervention (10 weeks)
Implementation of intervention and study procedures reports.
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: Measured at post-intervention (6 months)
Practicalities of intervention.
Measured with time for participants to work through all steps in intervention.
Measured: Measured at post-intervention (10 weeks)
Practicalities of intervention.
Measured with time for participants to work through all steps in intervention.
Measured: Measured at post-intervention (6 months)
Practicalities of study procedures.
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: Measured at post-intervention (10 weeks)
Practicalities of study procedures.
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: Measured at post-intervention (6 months)
Adaption of study procedures.
Measured with reports of different strategies (e.g. dissemination, recruitment, query resolution) required for Portugal (PT) and United Kingdom (UK).
Measured: Measured at post-intervention (10 weeks)
Adaption of study procedures.
Measured with reports of different strategies (e.g. dissemination, recruitment, query resolution) required for Portugal (PT) and United Kingdom (UK).
Measured: Measured at post-intervention (6 months)
Limited Efficacy Testing - changes from baseline in mental health
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.
Measured: From baseline to 10 weeks.
Limited Efficacy Testing - changes from baseline in mental health
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.
Measured: From baseline to 6 months.
Limited Efficacy Testing - changes from baseline in hedonic wellbeing
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.
Measured: From baseline to 10 weeks.
Limited Efficacy Testing - changes from baseline in hedonic wellbeing
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.
Measured: From baseline to 6 months.
Limited Efficacy Testing - changes from baseline in eudaimonic wellbeing
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.
Measured: From baseline to 10 weeks.
Limited Efficacy Testing - changes from baseline in eudaimonic wellbeing
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.
Measured: From baseline to 6 months.
Limited Efficacy Testing - changes from baseline in posttraumatic growth
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.
Measured: From baseline to 10 weeks.
Limited Efficacy Testing - changes from baseline in posttraumatic growth
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.
Measured: From baseline to 6 months.
Limited Efficacy Testing - changes from baseline in happiness
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.
Measured: From baseline to 10 weeks.
Limited Efficacy Testing - changes from baseline in happiness
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.
Measured: From baseline to 6 months.
Limited Efficacy Testing - changes from baseline in satisfaction with life
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.
Measured: From baseline to 10 weeks.
Limited Efficacy Testing - changes from baseline in satisfaction with life
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.
Measured: From baseline to 6 months.
Secondary outcomes (8)
Changes from baseline in acceptance
Measured with the SCREENIVF Questionnaire (partial) (Verhaak et al., 2010). The total score ranges between 6 to 24, with higher scores indicating higher acceptance.
Measured: From baseline to 10 weeks.
Changes from baseline in self-compassion
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)
Measured: From baseline to 10 weeks.
Changes from baseline in openness to experience (acceptance and defusion)
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.
Measured: From baseline to 10 weeks.
Changes from baseline in positive reframing coping
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)
Measured: From baseline to 10 weeks.
Changes from baseline in valued action
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.
Measured: From baseline to 10 weeks.
Changes from baseline in goal re-engagement
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)
Measured: From baseline to 10 weeks.
Changes from baseline in committed action
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.
Measured: From baseline to 10 weeks.
Changes from baseline in social connection
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.
Measured: From baseline to 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start6 Nov 2020
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Collaborators
- Portuguese Fertility Association, Fertility Network UK
- Responsible party
- Principal investigator, Sofia Gameiro, Cardiff University
- Investigators
- Beth Rowbottom, Principal investigator, School of Psychology, Cardiff UniversitySofia Gameiro, Principal investigator, School of Psychology, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850482
- Sponsor's protocol ID
- EC.20.10.13.6082
- Status last verified
- Aug 2021
- First submitted
- 13 Jan 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gameiro S, Finnigan A. Long-term adjustment to unmet parenthood goals following ART: a systematic review and meta-analysis. Hum Reprod Update. 2017 May 1;23(3):322-337. doi: 10.1093/humupd/dmx001.
PubMed 28164236Verhaak CM, Lintsen AM, Evers AW, Braat DD. Who is at risk of emotional problems and how do you know? Screening of women going for IVF treatment. Hum Reprod. 2010 May;25(5):1234-40. doi: 10.1093/humrep/deq054. Epub 2010 Mar 13.
PubMed 20228392Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
PubMed 21584907Francis, A. W., Dawson, D. L., & Golijani-Moghaddam, N. The development and validation of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of contextual behavioral science. 2016; 5(3): 134-145.
Wrosch C, Scheier MF, Miller GE, Schulz R, Carver CS. Adaptive self-regulation of unattainable goals: goal disengagement, goal reengagement, and subjective well-being. Pers Soc Psychol Bull. 2003 Dec;29(12):1494-508. doi: 10.1177/0146167203256921.
PubMed 15018681McCracken LM, Chilcot J, Norton S. Further development in the assessment of psychological flexibility: a shortened Committed Action Questionnaire (CAQ-8). Eur J Pain. 2015 May;19(5):677-85. doi: 10.1002/ejp.589. Epub 2014 Sep 2.
PubMed 25181605Newton CR, Sherrard W, Glavac I. The Fertility Problem Inventory: measuring perceived infertility-related stress. Fertil Steril. 1999 Jul;72(1):54-62. doi: 10.1016/s0015-0282(99)00164-8.
PubMed 10428148Rowbottom 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.
PubMed 36001052
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Randomised Controlled Trial of the MyJourney Web App, Supporting Adjustment to an Unfulfilled Wish for Children.
- ClinicalTrials.gov ID
- NCT04850482
- Acronym / sponsor ID
- EC.20.10.13.6082
- Conditions
- Mental Health
- Keywords
- Well being, Unfulfilled wish for children, Self-Help, Online intervention, Involuntary childlessness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Collaborators
- Portuguese Fertility Association, Fertility Network UK
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: MyJourneyParticipants get immediate access to the intervention on completion of baseline assessment. |
| Wait list control Arm | No intervention | –Participants get access to the intervention in 10 weeks after completion of the baseline and follow up assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyJourneyMyJourney is an online self-help interactive program based on Contextual Cognitive Behavioural Therapy. | Other | Intervention Arm |
Primary outcome
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).
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).
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.
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).
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).
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.
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.
Practicalities of intervention.
Time frame: Measured at post-intervention (10 weeks)
Measured with time for participants to work through all steps in intervention.
Practicalities of intervention.
Time frame: Measured at post-intervention (6 months)
Measured with time for participants to work through all steps in intervention.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
8 secondary outcomes
Changes from baseline in acceptance
Time frame: From baseline to 10 weeks.
Changes from baseline in self-compassion
Time frame: From baseline to 10 weeks.
Changes from baseline in openness to experience (acceptance and defusion)
Time frame: From baseline to 10 weeks.
Changes from baseline in positive reframing coping
Time frame: From baseline to 10 weeks.
Changes from baseline in valued action
Time frame: From baseline to 10 weeks.
Changes from baseline in goal re-engagement
Time frame: From baseline to 10 weeks.
Changes from baseline in committed action
Time frame: From baseline to 10 weeks.
Changes from baseline in social connection
Time frame: From baseline to 10 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 28164236Gameiro S, Finnigan A. Long-term adjustment to unmet parenthood goals following ART: a systematic review and meta-analysis. Hum Reprod Update. 2017 May 1;23(3):322-337. doi: 10.1093/humupd/dmx001.
- Background: PubMed 20228392Verhaak CM, Lintsen AM, Evers AW, Braat DD. Who is at risk of emotional problems and how do you know? Screening of women going for IVF treatment. Hum Reprod. 2010 May;25(5):1234-40. doi: 10.1093/humrep/deq054. Epub 2010 Mar 13.
- Background: PubMed 21584907Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
- BackgroundFrancis, A. W., Dawson, D. L., & Golijani-Moghaddam, N. The development and validation of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of contextual behavioral science. 2016; 5(3): 134-145.
- Background: PubMed 15018681Wrosch C, Scheier MF, Miller GE, Schulz R, Carver CS. Adaptive self-regulation of unattainable goals: goal disengagement, goal reengagement, and subjective well-being. Pers Soc Psychol Bull. 2003 Dec;29(12):1494-508. doi: 10.1177/0146167203256921.
- Background: PubMed 25181605McCracken LM, Chilcot J, Norton S. Further development in the assessment of psychological flexibility: a shortened Committed Action Questionnaire (CAQ-8). Eur J Pain. 2015 May;19(5):677-85. doi: 10.1002/ejp.589. Epub 2014 Sep 2.
- Background: PubMed 10428148Newton CR, Sherrard W, Glavac I. The Fertility Problem Inventory: measuring perceived infertility-related stress. Fertil Steril. 1999 Jul;72(1):54-62. doi: 10.1016/s0015-0282(99)00164-8.
- Derived from this study: PubMed 36001052Rowbottom 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.
- MyJourney websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Rowbottom principal investigator
School of Psychology, Cardiff University
Sofia Gameiro principal investigator
School of Psychology, Cardiff University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyJourney in people with Mental Health, run by Cardiff University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of intervention: data directly from web app and survey questions. (time frame: Measured at post-intervention (10 weeks)). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04850482, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.