ClinicalTrials.Veeva

Menu

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

C

Catholic University (KU) of Leuven

Status

Unknown

Conditions

Infertility

Treatments

Behavioral: mobile mindfulness programme

Study type

Interventional

Funder types

Other

Identifiers

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)

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.

Trial contacts and locations

1

Loading...

Central trial contact

Tessy Boedt, MSc.; Katleen Van der Gucht, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems