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

NCT04850482 | Unknown

• 1 other identifier: EC.20.10.13.6082
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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).

Conditions

Mental Health

Keywords

Well being; Unfulfilled wish for children; Self-Help; Online intervention; Involuntary childlessness

Outcome Measures

Primary Outcomes (25)

• 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 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 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 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 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 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 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 at post-intervention (6 months)

• Practicalities of intervention.

  Measured with time for participants to work through all steps in intervention.

  Measured at post-intervention (10 weeks)

• Practicalities of intervention.

  Measured with time for participants to work through all steps in intervention.

  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 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 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 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 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  From baseline to 6 months.

Secondary Outcomes (8)

• Changes from baseline in acceptance

  From baseline to 10 weeks.

• Changes from baseline in self-compassion

  From baseline to 10 weeks.

• Changes from baseline in openness to experience (acceptance and defusion)

  From baseline to 10 weeks.

• Changes from baseline in positive reframing coping

  From baseline to 10 weeks.

• Changes from baseline in valued action

  From baseline to 10 weeks.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants get immediate access to the intervention on completion of baseline assessment.

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.

Interventions

MyJourney OTHER

MyJourney is an online self-help interactive program based on Contextual Cognitive Behavioural Therapy.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cardiff University: lead
• Portuguese Fertility Association: collaborator
• Fertility Network UK: collaborator

Study Sites (1)

Cardiff University

Cardiff, CF10 3AT, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 28164236 BACKGROUND

• Verhaak 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.

  PMID: 20228392 BACKGROUND

• Raes 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.

  PMID: 21584907 BACKGROUND

• Francis, 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

• 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.

  PMID: 15018681 BACKGROUND

• McCracken 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.

  PMID: 25181605 BACKGROUND

• Newton 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.

  PMID: 10428148 BACKGROUND

• 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.

  PMID: 36001052 DERIVED

Related Links

• MyJourney website

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Beth Rowbottom

  School of Psychology, Cardiff University

  PRINCIPAL INVESTIGATOR

• Sofia Gameiro

  School of Psychology, Cardiff University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: April 20, 2021
• Study Start: November 6, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

GB (1)