Infertility Clinical Trial
— MBPIOfficial title:
Mindfulness Based Program for Infertility
Verified date | May 2018 |
Source | University of Coimbra |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The current study aims to test the efficacy a mindfulness based intervention for women facing fertility problems - the Mindfulness Based Program for Infertility (MBPI). MBPI comprises 10 weekly group sessions of approximately 2 hours each, run in small groups of 10-15 women. The main goal of MBPI intervention is to reduce depressive and anxiety symptoms and promote infertility self-efficacy and acceptance and mindfulness skills. The MBPI is intended to develop willingness/acceptance through a process of contacting the present moment and be in touch with the unfolding experience in an open and non-judgmental way, particularly infertility-related experiences.
Status | Completed |
Enrollment | 92 |
Est. completion date | December 2017 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility |
Inclusion Criteria: - Women dealing with an infertility diagnosis (independently of female, male, both female and male or unknown factor), pursuing infertility medical treatment Exclusion Criteria: - Severe psychiatric problems assessed through a semi-structured clinical interview used for MBPI admission |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Coimbra | Portuguese Fertility Association |
Galhardo A, Cunha M, Pinto-Gouveia J. Measuring self-efficacy to deal with infertility: Psychometric properties and confirmatory factor analysis of the Portuguese version of the infertility self-efficacy scale. Res Nurs Health. 2013 Feb;36(1):65-74. doi: 10.1002/nur.21516. Epub 2012 Oct 18. — 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
Galhardo A, Moura-Ramos M, Cunha M, Pinto-Gouveia J. The infertility trap: how defeat and entrapment affect depressive symptoms. Hum Reprod. 2016 Feb;31(2):419-26. doi: 10.1093/humrep/dev311. Epub 2015 Dec 17. — View Citation
Galhardo A, Pinto-Gouveia J, Cunha M, Matos M. The impact of shame and self-judgment on psychopathology in infertile patients. Hum Reprod. 2011 Sep;26(9):2408-14. doi: 10.1093/humrep/der209. Epub 2011 Jul 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in external shame assessed by the Others As Shamer (OAS) | Assessed by the Others As Shamer (OAS) | 7 years and 8 months (from Baseline to 7-years follow-up) | |
Other | Changes in entrapment assessed by the Entrapment Scale (ES) | Assessed by the Entrapment Scale (ES) | 8 months (from Baseline to 6-months follow-up) | |
Other | Changes in defeat assessed by the Defeat Scale (DS) | Assessed by the Defeat Scale (DS) | 8 months (from Baseline to 6-months follow-up) | |
Primary | Changes in depressive symptoms assessed by the Beck Depressive Inventory (BDI) | Assessed by the Beck Depressive Inventory (BDI) | 7 years and 8 months (from Baseline to 7-years follow-up) | |
Primary | Changes in Mindfulness skills assessed by the Five Facet Mindfulness Questionnaire (FFMQ) | Assessed by the Five Facet Mindfulness Questionnaire (FFMQ) | 7 years and 8 months (from Baseline to 7-years follow-up) | |
Primary | Changes in perceptions of infertility self-efficacy assessed by the Infertility Self-efficacy Scale (ISE) | Assessed by the Infertility Self-efficacy Scale (ISE) | 7 years and 8 months (from Baseline to 7-years follow-up) | |
Secondary | Changes in anxiety symptoms assessed by the Spielberger State Anxiety Inventory (STAI-Y1) | Assessed by the Spielberger State Anxiety Inventory (STAI-Y1) | 7 years and 8 months (from Baseline to 7-years follow-up) | |
Secondary | Changes in acceptance skills assessed by the Acceptance and Action Questionnaire (AAQ-II) | Assessed by the Acceptance and Action Questionnaire (AAQ-II) | 7 years and 8 months (from Baseline to 7-years follow-up) | |
Secondary | Changes in self-compassion assessed by the Self-compassion Scale (SCS) | Assessed by the Self-compassion Scale (SCS) | 7 years and 8 months (from Baseline to 7-years follow-up) |
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