Infertility Clinical Trial
— KindMapOfficial 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.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Portugal | Faculty of Psychology and Education Sciences, University of Coimbra | Coimbra |
Lead Sponsor | Collaborator |
---|---|
University of Coimbra |
Portugal,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demand | Measured through the feasibility criteria questionnaire (to be developed by the researchers) to assess program adherence (e.g., number of users, percentage of modules completed). | 10 weeks | |
Other | Adaptation | Measured through data stored in the web app to assess differences in number of participants engaging with the KindMap in Portuguese and English; differences between participants engaging with the KindMap in Portuguese and English in hours spent overall and total number of visits. | 10 weeks | |
Other | Acceptability | Measured through the feasibility criteria questionnaire (to be developed by the researchers) to assess overall program satisfaction, perceived usefulness of each module and meditation practices and willingness to recommend KindMap to peers. | 10 weeks | |
Other | Implementation | Measured through the feasibility criteria questionnaire (to be developed by the researchers) to address responses to open-ended questions regarding technical problems and suitability of 10-week recommended engagement period. | 10 weeks | |
Other | Practicality | Measured through the data stored in the web app to assess number of participants who used the KindMap as intended (completed 10 modules) and completed the sufficient dose during the 10-week recommended engagement period; time taken to use the web app as intended and complete the sufficient dose. | 10 weeks | |
Other | Integration | Measured through the feasibility criteria questionnaire (to be developed by the researchers) to assess how participants use the KindMap skills in everyday life and their willingness to continue to do so in the future. | 10 weeks | |
Other | Limited efficacy | Measured through standardised self-report measures. Limited efficacy was operationalised as effect size estimations of primary and secondary self-reported outcomes changes in the EG-KindMap vs WL-CG. | 10 weeks | |
Primary | 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 | 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. | baseline and 10 weeks | |
Secondary | 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. | baseline and 10 weeks | |
Secondary | 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. | baseline and 10 weeks | |
Secondary | 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. | baseline and 10 weeks | |
Secondary | 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. | baseline and 10 weeks | |
Secondary | 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. | baseline and 10 weeks | |
Secondary | 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. | baseline and 10 weeks |
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