A Mobile Mindfulness Programme for Individuals/Couples Experiencing Fertility Problems
- Conditions
- Infertility
- Interventions
- Behavioral: mobile mindfulness programme
- Registration Number
- NCT04143828
- Lead Sponsor
- KU Leuven
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
Not applicable
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mobile Mindfulness Programme mobile mindfulness programme The mobile mindfulness program is delivered via a mobile application.
- Primary Outcome Measures
Name Time Method Fertility related quality of life Data collected at baseline (before randomisation), after 1.5 and 3 months Change in scores on the Fertility Quality of Life Questionnaire (FertiQol) - 24 items; scoring: 0-100 (the higher the better the quality of life)
emotional distress Data collected at baseline (before randomisation), after 1.5 and 3 months 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)
- Secondary Outcome Measures
Name Time Method use of the mobile Mindfulness Programme (mMP) After 1.5 and 3 months in the intervention group evaluating the use of the mMP (frequency) in combination with a question on their motivation of (not) using mMP
subjective quality of the mobile Mindfulness Programme (mMP) after 3 months in the intervention group 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)
self-compassion Data collected at baseline (before randomisation), after 1.5 and 3 months Change in scores on the Self Compassion Scale (SCS-NL-R) - 12 items; scoring: 12-60 (the higher the more self-compassion)
mindfulness skills Data collected at baseline (before randomisation), after 1.5 and 3 months 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)
repetitive negative thoughts Data collected at baseline (before randomisation), after 1.5 and 3 months Change in scores on the Perseverative Thinking Questionnaire (PTQ) - 15 items; scoring: 0-60 (the higher, the more repetitive negative thinking)
Emotional distress Data collected at baseline (before randomisation), after 1,5 and 3 months Change in scores on the Depression, Anxiety and Stress Scale (DASS-21); scoring: 0-126 (the higher the more emotional distress)
Mindfulness skills Data collected at baseline (before randomisation), after 1,5 and 3 months Change in scores on the Comprehensive Inventory of Mindfulness Experiences (CHIME-SF) - 24 items; scoring: 24-144 (the higher the better the mindfulness skills)
Trial Locations
- Locations (1)
KU Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium