KindMap: an e-mental health tool to promote the well-being and mental health of people facing infertility-study protocol for a feasibility randomised control trial.

INTRODUCTION

Fertility patients increasingly use web-based and mobile-based apps to access psychosocial care. These digital tools may be a helpful alternative to traditional psychological interventions. Developing and evaluating patient-centred e-mental health tools rooted in evidence-based interventions is a priority. The KindMap is a stand-alone, cost-free e-mental health intervention derived from adapting the Mindfulness Based Programme for Infertility (MBPI) contents to a digital format. The KindMap integrates mindfulness and self-compassion skills training and Acceptance and Commitment Therapy components. This protocol is intended to evaluate the KindMap's feasibility and explore the extent to which the web-app mode of delivery limited efficacy results are similar to the MBPI in-person format results. Furthermore, it will test the causal theory underlying KindMap.

METHODS AND ANALYSIS

A two-arm 2:1 non-blinded feasibility randomised controlled trial (RCT) will be conducted. Participants are people dealing with infertility, who are able to access the Internet and understand Portuguese or English. Consent participants will complete an online survey at 3-time assessment moments. After baseline assessment, participants will be randomised into the KindMap experimental group (KindMap-EG; with immediate access to the web app) or the waiting-list control group. The primary outcome is well-being (WHO Index-5); secondary outcomes are infertility-related stress (Fertility Problem Inventory-Short Form), anxiety and depression (Patient Health Questionnaire for Depression and Anxiety-4); mindfulness (Five Facet Mindfulness Questionnaire-Short Form), self-compassion (Self-Compassion Scale-Short Form), psychological flexibility (Psy-Flex) and infertility-related self-efficacy are the potential mechanisms of change. KindMap-EG will also complete a feasibility survey.

ETHICS AND DISSEMINATION

The study was approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences of the University of Coimbra (Identifier: CEDI/FPCEUC:78/R_10). The KindMap study may contribute to the existing research on e-health technologies applied to mental health. The study outcomes will be disseminated through publications in peer-reviewed journals and national and international conference presentations.

TRIAL REGISTRATION NUMBER

NCT05899374.