Clinical trial NCT04143828: A Mobile Mindfulness Programme for Individuals/Couples Experiencing Fertility Problems
Official title: MoMiFer-Study: Evaluation of a Mobile Mindfulness Program (mMP) in Individuals/Couples Experiencing Fertility Problems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: Infertility
Mobile Health
Mindfulness
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2019-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two conditions: The intervention group receives a mobile mindfulness programme (mMP). The participants in the control group are wait-listed. They will receive access to the mobile mindfulness programme after three months.
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fertility related quality of life
timeFrame: Data collected at baseline (before randomisation), after 1.5 and 3 months
measure: emotional distress
timeFrame: Data collected at baseline (before randomisation), after 1.5 and 3 months
Secondary outcomes:
measure: repetitive negative thoughts
timeFrame: Data collected at baseline (before randomisation), after 1.5 and 3 months
measure: mindfulness skills
timeFrame: Data collected at baseline (before randomisation), after 1.5 and 3 months
measure: self-compassion
timeFrame: Data collected at baseline (before randomisation), after 1.5 and 3 months
measure: Emotional distress
timeFrame: Data collected at baseline (before randomisation), after 1,5 and 3 months
measure: Mindfulness skills
timeFrame: Data collected at baseline (before randomisation), after 1,5 and 3 months
measure: subjective quality of the mobile Mindfulness Programme (mMP)
timeFrame: after 3 months in the intervention group
measure: use of the mobile Mindfulness Programme (mMP)
timeFrame: After 1.5 and 3 months in the intervention group
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven, UZ Leuven
name: Sharon Lie Fong, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Leuven Mindfulness Centre - KU Leuven
name: Filip Raes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boedt T, Willaert N, Lie Fong S, Dancet E, Spiessens C, Raes F, Matthys C, Van der Gucht K. Evaluation of a stand-alone mobile mindfulness app in people experiencing infertility: the protocol for an exploratory randomised controlled trial (MoMiFer-RCT). BMJ Open. 2022 Feb 2;12(2):e050088. doi: 10.1136/bmjopen-2021-050088.