A Mobile Mindfulness Programme for Individuals/Couples Experiencing Fertility Problems (MoMiFer)

Catholic University (KU) of Leuven

Status: Unknown

Conditions: Infertility

Treatments: Behavioral: mobile mindfulness programme

Study type: Interventional

Funder types: Other

Identifiers

NCT04143828

S62323

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Mobile Mindfulness Programme

Experimental group

Description:

The mobile mindfulness program is delivered via a mobile application.

Treatment:

Behavioral: mobile mindfulness programme

Wait-list control condition

No Intervention group

Description:

When assigned to the control condition, participants will be wait-listed for 3 months during the study. After the final assessment participants will receive access to the mobile mindfulness program.