Mindfulness Based Program for Infertility

NCT03012412 | Completed

• 1 other identifier: SFRH/BD/68392/2010-04
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (3)

• Changes in anxiety symptoms assessed by the Spielberger State Anxiety Inventory (STAI-Y1)

  7 years and 8 months (from Baseline to 7-years follow-up)

• Changes in acceptance skills assessed by the Acceptance and Action Questionnaire (AAQ-II)

  7 years and 8 months (from Baseline to 7-years follow-up)

• Changes in self-compassion assessed by the Self-compassion Scale (SCS)

  7 years and 8 months (from Baseline to 7-years follow-up)

Other Outcomes (3)

• Changes in external shame assessed by the Others As Shamer (OAS)

  7 years and 8 months (from Baseline to 7-years follow-up)

• Changes in entrapment assessed by the Entrapment Scale (ES)

  8 months (from Baseline to 6-months follow-up)

• Changes in defeat assessed by the Defeat Scale (DS)

  8 months (from Baseline to 6-months follow-up)

Study Arms (2)

Mindfulness Based Program for Infertility

EXPERIMENTAL

Behavioral: MBPI The Mindfulness Based Program for Infertility is a manualized group psychological intervention derived from contextual or 3rd wave cognitive-behavioral therapies intended to develop mindfulness and acceptance skills, as well as to promote perceptions of self-efficacy to deal with the demands of an infertility diagnosis and medical treatment. It comprises 10 weekly sessions of approximately 2hr each, run in small groups (ranging from 10 to 15 participants).

Behavioral: Mindfulness Based Program for Infertility

Treatment As Usual (TAU)

NO INTERVENTION

Standard infertility medical treatment provided by IVF clinics (public and private) - no psychological intervention being pursued.

Interventions

Mindfulness Based Program for Infertility BEHAVIORAL

The Mindfulness Based Program for Infertility is a manualized group psychological intervention derived from contextual or 3rd wave cognitive-behavioral therapies intended to develop mindfulness and acceptance skills, as well as to promote perceptions of self-efficacy to deal with the demands of an infertility diagnosis and medical treatment. It comprises 10 weekly sessions of approximately 2hr each, run in small groups (ranging from 10 to 13 participants).

Also known as: MBPI

Mindfulness Based Program for Infertility

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women dealing with an infertility diagnosis (independently of female, male, both female and male or unknown factor), pursuing infertility medical treatment

You may not qualify if:

• Severe psychiatric problems assessed through a semi-structured clinical interview used for MBPI admission

Sponsors & Collaborators

• University of Coimbra: lead
• Portuguese Fertility Association: collaborator

Related Publications (4)

• 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.

  PMID: 23081663 BACKGROUND

• 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.

  PMID: 26677954 BACKGROUND

• 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.

  PMID: 21727160 BACKGROUND

• 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 RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• José A Pinto-Gouveia, MD, PhD

  CINEICC - Faculty of Psychology and Educational Sciences of the University of Coimbra

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 6, 2017
• Study Start: May 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share