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

NCT04850482 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2021-08-03

No results posted yet for this study

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

Interventions

OTHER

MyJourney

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

Sponsors & Collaborators

  • Portuguese Fertility Association

    collaborator UNKNOWN

  • Fertility Network UK

    collaborator UNKNOWN

  • Cardiff University

    lead OTHER

Principal Investigators

  • Beth Rowbottom · School of Psychology, Cardiff University

  • Sofia Gameiro · School of Psychology, Cardiff University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04850482 on ClinicalTrials.gov