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

NCT05899374 | Unknown

• 2 other identifiers: KindMap.2022.138952022.13895.BD
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Infertility; E-mental health; Mindfulness; Compassion; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in Well-being

  Measured with World Health Organisation- Five Well-Being Index (WHO-5). The total raw score, ranging from 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.

  baseline and 10 weeks

Secondary Outcomes (7)

• Changes from baseline in depression

  baseline and 10 weeks

• Changes from baseline in anxiety

  baseline and 10 weeks

• Changes from baseline in infertility-related stress

  baseline and 10 weeks

• Changes from baseline in mindfulness

  baseline and 10 weeks

• Changes from baseline in self-compassion

  baseline and 10 weeks

Other Outcomes (7)

• Demand

  10 weeks

• Adaptation

  10 weeks

• Acceptability

  10 weeks

Study Arms (2)

Experimental KindMap Group

EXPERIMENTAL

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

Behavioral: KindMap

Wait-list Control Group

NO INTERVENTION

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.

Interventions

KindMap 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.

Experimental KindMap Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45
• At any stage of the fertility journey
• Internet access

You may not qualify if:

• Currently undergoing any form of psychological intervention
• 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.

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

Faculty of Psychology and Education Sciences, University of Coimbra

Coimbra, 3000-115, Portugal

Location

Related Publications (3)

• 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.

  PMID: 23809500 BACKGROUND

• 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.

  PMID: 30812065 BACKGROUND

• 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.

  PMID: 39653558 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Naír Carolino

  Instituto Superior Miguel Torga; University of Coimbra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naír Carolino

CONTACT

+351912031000; naircarolino@gmail.com

Study Design

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

Model Details: 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).

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 12, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)