Clinical trial NCT05899374: KindMap - an E-mental Health Intervention Tool for Improving Well-being and Mental Health in People Facing Infertility
Official title: KindMap - an E-mental Health Intervention Tool for Improving Well-being and Mental Health in People Facing Infertility: A Feasibility Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: Infertility
E-mental health
Mindfulness
Compassion
Acceptance and Commitment Therapy
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be recruited through APFertilidade and Fertility Europe (European Umbrella organisation of patients' associations). Consenting participants will be randomly allocated (www.random.org) to the experimental group (immediate access to KindMap-EG-KindMap) and waiting-list control group (access to KindMap after T2-WL-CG).
Primary purpose: OTHER

Brief summary: Infertility affects millions of people of reproductive age worldwide, and its consequences extend to emotional, relational and social life domains. This experience may induce infertility-related stress, anxiety, and depression and activate maladaptive emotion regulation mechanisms. The KindMap is an Information and Communication Technology-based intervention comprising mindfulness, Acceptance and Commitment Therapy, and compassion components targeting people with infertility. KindMap contents are derived from adapting the Mindfulness-Based Program for Infertility (MBPI) - in-person psychological group intervention. Adapting the MBPI to a cost-free, self-guided web app will increase accessibility, but it remains unknown if feasible. The current project aims to test the KindMap prototype version's feasibility. The KindMap project will provide a free and easy-to-use psychological intervention aiming at improving the well-being, infertility self-efficacy and mental health of those affected by infertility.

Detailed description: The KindMap is a stand-alone, cost-free e-mental health tool presenting a low-intensive psychological intervention adapted from the Mindfulness Based Program for Infertility (MBPI) to fit a web app format. The MBPI is a psychological intervention comprising psychoeducation, mindfulness, compassion and Acceptance and Commitment Therapy (ACT) components. The MBPI is an in-person group intervention that has proved to improve mental health, with sustained benefits for as long as seven years, regardless of people's reproductive outcomes. Following the framework commissioned by the Medical Research Council and the National Institute of Health Research for developing complex interventions and a User-Centered Design (UCD) methodology, a multidisciplinary research team developed the KindMap. The KindMap web app aims to promote well-being and mental health of people dealing with infertility, supporting them to live a more vital and meaningful life.

The current study aims: 1) to evaluate the KindMap's feasibility (demand, adaptation, acceptability, implementation, practicality, integration, and limited efficacy testing); 2) to explore the extent to which the web app mode of delivery limited efficacy results are similar to the MBPI in-person format results. To accomplish these aims, a two-arm 1:1, non-blinded feasibility Randomised Controlled Trial (RCT) will be conducted. This project was submitted to the Ethics Committee of the Faculty of Psychology and Educational Sciences of the University of Coimbra.

Participants will be recruited through APFertilidade and Fertility Europe (European Umbrella organisation of patients' associations). Participants who demonstrate an interest in the study will be informed of the study aims, the structure and arms, and the researchers' and participants' roles. Participants who agree to participate in the study will sign an informed consent form.

All ethical requirements for research with humans will be guaranteed. Consenting participants will be randomly allocated (www.random.org) to the experimental group (EG-KindMap) (immediate access to KindMap) and the waiting-list control group (WL-CG) (access to KindMap after T2). Participants will complete a set of standardised self-report measures online, pre- (T1) and post-intervention (T2). At T2, the EG-KindMap will complete a questionnaire assessing the feasibility criteria. The limited efficacy dimension will be assessed using modified Intention-to-Treat and per-protocol analyses. Data analysis will be conducted using Statistical Package for the Social Sciences (SPSS) and Analysis of Moment Structures (AMOS).

KindMap is an innovative and timely project because it addresses the increasing demand for online cost-free and evidence-based support for people negatively impacted by infertility. KindMap will be the first e-mental health intervention integrating psychoeducation, mindfulness, compassion and ACT components.

It is expected that the KindMap reveals to be a feasible low-intensive psychological intervention with limited efficacy results pointing to improvements in well-being and mental health indicators (stress, depression, and anxiety).

KindMap can reach a broader number of fertility patients, being disseminated through fertility clinics and patients' associations, providing additional support aligned with a more patient-centred care framework. The KindMap may also impact clinical practice and services. It may be used both as a stand-alone tool and as a supplement to psychological interventions delivered by mental health professionals. In the future, the KindMap may also be translated into other languages.

Eligibility criteria: Inclusion Criteria:

1. Age 18-45
2. At any stage of the fertility journey
3. Internet access

Exclusion Criteria:

1. Currently undergoing any form of psychological intervention
2. Pregnancy

All participants will be informed that they will be randomized to one of the study groups, which will only be included if they give informed consent to participate.

Primary outcomes:
measure: Changes from baseline in Well-being
timeFrame: baseline and 10 weeks
Secondary outcomes:
measure: Changes from baseline in depression
timeFrame: baseline and 10 weeks
measure: Changes from baseline in anxiety
timeFrame: baseline and 10 weeks
measure: Changes from baseline in infertility-related stress
timeFrame: baseline and 10 weeks
measure: Changes from baseline in mindfulness
timeFrame: baseline and 10 weeks
measure: Changes from baseline in self-compassion
timeFrame: baseline and 10 weeks
measure: Changes from baseline in psychological flexibility
timeFrame: baseline and 10 weeks
measure: Changes from baseline in infertility-related self-efficacy
timeFrame: baseline and 10 weeks
Other outcomes:
measure: Demand
timeFrame: 10 weeks
measure: Adaptation
timeFrame: 10 weeks
measure: Acceptability
timeFrame: 10 weeks
measure: Implementation
timeFrame: 10 weeks
measure: Practicality
timeFrame: 10 weeks
measure: Integration
timeFrame: 10 weeks
measure: Limited efficacy
timeFrame: 10 weeks
Locations:
city: Coimbra
country: Portugal
facility: Faculty of Psychology and Education Sciences, University of Coimbra
Study officials:
affiliation: Instituto Superior Miguel Torga; University of Coimbra
name: Naír Carolino
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galhardo A, Cunha M, Pinto-Gouveia J. Mindfulness-Based Program for Infertility: efficacy study. Fertil Steril. 2013 Oct;100(4):1059-67. doi: 10.1016/j.fertnstert.2013.05.036. Epub 2013 Jun 27.
citation: Galhardo A, Cunha M, Pinto-Gouveia J. A 7-year follow-up study of the Mindfulness-Based Program for Infertility: Are there long-term effects? Clin Psychol Psychother. 2019 Jul;26(4):409-417. doi: 10.1002/cpp.2362. Epub 2019 Mar 20.