An interventional study of mobile mindfulness programme in Infertility, sponsored by KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2020-04-07.
Sponsored by KU Leuven · Not applicable, Interventional, and Supportive care
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
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Exclusion Criteria:
Not applicable
The mobile mindfulness program is delivered via a mobile application.
Behavioral: mobile mindfulness programme
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.
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.
Fertility 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
Plan to share: Yes — For all the data generated during the course of this project, the investigators will follow the prevailing standards and guidelines in documenting and depositing data sets. The investogators will disseminate results from this research through presentations at public lectures, scientific institutions and meetings, and/or publication in major journals. Regarding data sharing, ICMJE recommendations will be followed. Individual deidentified participant data will be shared. In particular, individual participant data that underlie the results reported in our articles, after deindentification (text, tables, figures and appendices).
Supporting information: Study protocol, Icf, Analytic code
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