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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
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.
KU Leuven
Leuven, Vlaams-Brabant, Belgium
RECRUITINGFertility 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)
Time frame: Data collected at baseline (before randomisation), after 1.5 and 3 months
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)
Time frame: Data collected at baseline (before randomisation), after 1.5 and 3 months
repetitive negative thoughts
Change in scores on the Perseverative Thinking Questionnaire (PTQ) - 15 items; scoring: 0-60 (the higher, the more repetitive negative thinking)
Time frame: Data collected at baseline (before randomisation), after 1.5 and 3 months
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)
Time frame: Data collected at baseline (before randomisation), after 1.5 and 3 months
self-compassion
Change in scores on the Self Compassion Scale (SCS-NL-R) - 12 items; scoring: 12-60 (the higher the more self-compassion)
Time frame: Data collected at baseline (before randomisation), after 1.5 and 3 months
Emotional distress
Change in scores on the Depression, Anxiety and Stress Scale (DASS-21); scoring: 0-126 (the higher the more emotional distress)
Time frame: Data collected at baseline (before randomisation), after 1,5 and 3 months
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)
Time frame: Data collected at baseline (before randomisation), after 1,5 and 3 months
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)
Time frame: after 3 months in the intervention group
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
Time frame: After 1.5 and 3 months in the intervention group
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