InfertilityKindMapNCT05899374
KindMap - an E-mental Health Intervention Tool for Improving Well-being and Mental Health in People Facing Infertility
A study testing KindMap in people with Infertility, run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Infertility
- What is being tested?
- KindMap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2023to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45
- At any stage of the fertility journey
- Internet access
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculty of Psychology and Education Sciences, University of Coimbra
Coimbra, 3000-115
Naír Carolino, +351912031000, naircarolino@gmail.com
Naír Carolino
About this study
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
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.
Read the 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
- Being tested
- KindMap
- Keywords
- Infertility, E-mental health, Mindfulness, Compassion, Acceptance and Commitment Therapy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KindMapBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental KindMap Group | Experimental | Participants in the experimental group will register, complete the baseline assessment and have immediate access to the KindMap web app. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 10 weeks
Secondary outcomes (7)
Changes from baseline in depression
Measured with depression subscale of the Patient Health Questionnaire-4 (PHQ-4). The total score for this subscale can range between 0 and 6, and 3 or greater scores on the depression subscale represent a reasonable cut-off point for identifying potential cases of depression.
Measured: baseline and 10 weeks
Changes from baseline in anxiety
Measured with anxiety subscale of the Patient Health Questionnaire-4 (PHQ-4). The total score for this subscale can range between 0 and 6, and 3 or greater scores on the anxiety subscale represent a reasonable cut-off point for identifying potential cases of anxiety.
Measured: baseline and 10 weeks
Changes from baseline in infertility-related stress
Measured with the Fertility Problems Inventory (FPI- short form). The total score for this scale can range between 45-149, and higher scores are indicative of more severe fertility-related stress.
Measured: baseline and 10 weeks
Changes from baseline in mindfulness
Measured with the Five- Facet Mindfulness Questionnaire (FFMQ-24). The total score for this scale can range between 24-120, and higher scores reveal more mindfulness skills.
Measured: baseline and 10 weeks
Changes from baseline in self-compassion
Measured with the Self-Compassion Scale - short form (SCS-SF). The total score for this scale can range between 12-60, and higher scores reveal more self-compassion.
Measured: baseline and 10 weeks
Changes from baseline in psychological flexibility
Measured with the Psy-Flex. The total score for this scale can range between 5-30, and higher scores indicate more psychological flexibility.
Measured: baseline and 10 weeks
Changes from baseline in infertility-related self-efficacy
Measured with the Infertility self-efficacy scale (ISE). The total score for this scale can range between 9-144, and higher scores indicate a higher perception of self-efficacy in dealing with fertility issues.
Measured: baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nair Carolino Albano, University of Coimbra
- Investigators
- Naír Carolino, Principal investigator, Instituto Superior Miguel Torga; University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899374
- Sponsor's protocol ID
- KindMap.2022.13895
- Other IDs
- 2022.13895.BD
- Acronym
- KindMap
- Status last verified
- Jun 2023
- First submitted
- 4 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23809500Galhardo 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.
PubMed 30812065Carolino 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.
PubMed 39653558
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05899374
- Acronym / sponsor ID
- KindMap / KindMap.2022.13895
- Conditions
- Infertility
- Keywords
- Infertility, E-mental health, Mindfulness, Compassion, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Experimental KindMap Group | Experimental | Behavioral: KindMapParticipants in the experimental group will register, complete the baseline assessment and have immediate access to the KindMap web app. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-45
- At any stage of the fertility journey
- Internet access
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KindMapThe 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. | Behavioural | Experimental KindMap Group |
Primary outcome
Changes from baseline in Well-being
Time frame: baseline and 10 weeks
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.
7 secondary outcomes
Changes from baseline in depression
Time frame: baseline and 10 weeks
Changes from baseline in anxiety
Time frame: baseline and 10 weeks
Changes from baseline in infertility-related stress
Time frame: baseline and 10 weeks
Changes from baseline in mindfulness
Time frame: baseline and 10 weeks
Changes from baseline in self-compassion
Time frame: baseline and 10 weeks
Changes from baseline in psychological flexibility
Time frame: baseline and 10 weeks
Changes from baseline in infertility-related self-efficacy
Time frame: baseline and 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 23809500Galhardo 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.
- Background: PubMed 30812065Galhardo 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.
- Derived from this study: PubMed 39653558Carolino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naír Carolino principal investigator
Instituto Superior Miguel Torga; University of Coimbra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KindMap in people with Infertility, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naír Carolino (+351912031000, naircarolino@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in Well-being (time frame: baseline and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05899374, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023; AzTrials last refreshed its copy on 29 Oct 2026.