KindMap - an E-mental Health Intervention Tool for Improving Well-being and Mental Health in People Facing Infertility

NCT ID: NCT05899374

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2024-10-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental KindMap Group

Participants in the experimental group will register, complete the baseline assessment and have immediate access to the KindMap web app.

Group Type: EXPERIMENTAL

KindMap

Intervention Type: BEHAVIORAL

The KindMap is a stand-alone, cost-free e-mental health tool presenting a low-intensive psychological intervention adapted from the MBPI to fit a web app format. KindMap is to be used at users' own time and pace, and includes ten modules addressing psychoeducation, mindfulness and compassion guided practices, and ACT-based experiential exercises. These components are delivered through text, videos, audio, experiential exercises, and interactive contents.

Wait-list Control Group

Participants in the WL-CG will complete the baseline assessment and will be able to register and have access to the KindMap web app 10 weeks later.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

KindMap

The KindMap is a stand-alone, cost-free e-mental health tool presenting a low-intensive psychological intervention adapted from the MBPI to fit a web app format. KindMap is to be used at users' own time and pace, and includes ten modules addressing psychoeducation, mindfulness and compassion guided practices, and ACT-based experiential exercises. These components are delivered through text, videos, audio, experiential exercises, and interactive contents.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Nair Carolino Albano

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naír Carolino

Role: PRINCIPAL_INVESTIGATOR

Instituto Superior Miguel Torga; University of Coimbra

Locations

Faculty of Psychology and Education Sciences, University of Coimbra

Coimbra, , Portugal

Countries

Portugal

Central Contacts

Naír Carolino

Role: CONTACT

naircarolino@gmail.com

+351912031000

Facility Contacts

Naír Carolino

Role: primary

naircarolino@gmail.com

+351912031000

References

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.

Reference Type: BACKGROUND

PMID: 23809500 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30812065 (View on PubMed)

Carolino N, Cunha M, Pinto-Gouveia J, Gameiro S, Galhardo A. 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. BMJ Open. 2024 Dec 9;14(12):e087447. doi: 10.1136/bmjopen-2024-087447.

Reference Type: DERIVED

PMID: 39653558 (View on PubMed)

Other Identifiers

2022.13895.BD

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KindMap.2022.13895

Identifier Type: -

Identifier Source: org_study_id