A Mobile Mindfulness Programme for Individuals/Couples Experiencing Fertility Problems

Infertility Clinical Trial

— MoMiFer  

Official title:

MoMiFer-Study: Evaluation of a Mobile Mindfulness Program (mMP) in Individuals/Couples Experiencing Fertility Problems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04143828
• Other study ID #: S62323
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2019
• Est. completion date: May 2021

Study information

• Verified date: April 2020
• Source: KU Leuven
• Contact: Katleen Van der Gucht, PhD
• Phone: +3216373183
• Email: katleen.vandergucht[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Infertility and its treatment result in a considerate emotional burden and a recent guideline of the European Society of Human Reproduction (ESHRE) highlight the importance to support couples facing fertility problems. Mindfulness-based programs (MBPs) have been proven effective in improving well-being and combatting mood disturbances in a wide range of conditions in both treatment and prevention. The overall aim of this project is to evaluate the impact of a mobile mindfulness programme (mMP) on quality of life and emotional well-being in individuals/couples experiencing fertility problems. The present study is a two-group randomized controlled trial with assessments at baseline, at 1,5 months and at 3 months. Sixty couples experiencing fertility problems will be enrolled. They will be assigned to either an intervention group (immediate access to the mMP) or a control group (waitlist condition). The mobile MBP is developed by a team of experienced mindfulness trainers, clinical psychologists, and a psychiatrist and adheres to a standardized protocol. The primary outcomes will be quality of life and emotional distress. Secondary outcomes will be repetitive negative thinking, self-compassion and mindfulness skills. Additionally, the feasibility of the mMP will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• Individuals/couples experiencing fertility problems (using the criteria for the definition of 'infertility', as in: the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse) (Zegers-Hochschild et al., 2017)

• Both partners possess a smartphone

• Both partners understand and speak Dutch

• Written informed consent after been informed on all aspects of the study

Exclusion Criteria:

Not applicable

Related Conditions & MeSH terms

• Infertility

Intervention

Behavioral:
• mobile mindfulness programme
The mobile mindfulness programme adheres to a standardized protocol developed from the MBSR curriculum (Kabat-Zinn, 1990). The program consists of six modules. Each module consists of a short movie (talking head) explaining the content and two audiofiles to guide experiential mindfulness meditation exercises. Participants can follow the different modules based on their own time-schedule. Key objectives are: (1) to increase awareness of one's present moment experience; (2) to teach an attitude of openness and acceptance (non-judging) toward one's experience.

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertility related quality of life	Change in scores on the Fertility Quality of Life Questionnaire (FertiQol) - 24 items; scoring: 0-100 (the higher the better the quality of life)	Data collected at baseline (before randomisation), after 1.5 and 3 months
Primary	emotional distress	Change in scores on experienced stress, anxiety and depression as measured by Experience Sampling Method (record emotions several times a day during 4 consecutive days); scoring with a sliding bar: 0-100 (the lower the less emotional distress)	Data collected at baseline (before randomisation), after 1.5 and 3 months
Secondary	repetitive negative thoughts	Change in scores on the Perseverative Thinking Questionnaire (PTQ) - 15 items; scoring: 0-60 (the higher, the more repetitive negative thinking)	Data collected at baseline (before randomisation), after 1.5 and 3 months
Secondary	mindfulness skills	Change in scores on experienced mindfulness skills as measured by Experience Sampling Method (several times a day during 4 consecutive days); scoring with a sliding bar: 0-100 (the higher the better the mindfulness skills)	Data collected at baseline (before randomisation), after 1.5 and 3 months
Secondary	self-compassion	Change in scores on the Self Compassion Scale (SCS-NL-R) - 12 items; scoring: 12-60 (the higher the more self-compassion)	Data collected at baseline (before randomisation), after 1.5 and 3 months
Secondary	Emotional distress	Change in scores on the Depression, Anxiety and Stress Scale (DASS-21); scoring: 0-126 (the higher the more emotional distress)	Data collected at baseline (before randomisation), after 1,5 and 3 months
Secondary	Mindfulness skills	Change in scores on the Comprehensive Inventory of Mindfulness Experiences (CHIME-SF) - 24 items; scoring: 24-144 (the higher the better the mindfulness skills)	Data collected at baseline (before randomisation), after 1,5 and 3 months
Secondary	subjective quality of the mobile Mindfulness Programme (mMP)	a shortened version of the subjective quality subscale of the Mobile App Rating Scale (MARS); scoring: 0-8 (the higher, the better the quality of the mMP)	after 3 months in the intervention group
Secondary	use of the mobile Mindfulness Programme (mMP)	evaluating the use of the mMP (frequency) in combination with a question on their motivation of (not) using mMP	After 1.5 and 3 months in the intervention group