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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Mindfulness Programme | Experimental | The mobile mindfulness program is delivered via a mobile application. |
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| Wait-list control condition | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile mindfulness programme | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | Data collected at baseline (before randomisation), after 1.5 and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| repetitive negative thoughts | Change in scores on the Perseverative Thinking Questionnaire (PTQ) - 15 items; scoring: 0-60 (the higher, the more repetitive negative thinking) | Data collected at baseline (before randomisation), after 1.5 and 3 months |
| mindfulness skills |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katleen Van der Gucht, PhD | Contact | +3216373183 | katleen.vandergucht@kuleuven.be | |
| Tessy Boedt, MSc. | Contact | +32486804604 | tessy.boedt@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Sharon Lie Fong, MD. PhD. | KU Leuven, UZ Leuven | Principal Investigator |
| Filip Raes, PhD | Leuven Mindfulness Centre - KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35110309 | Derived | Boedt T, Willaert N, Lie Fong S, Dancet E, Spiessens C, Raes F, Matthys C, Van der Gucht K. Evaluation of a stand-alone mobile mindfulness app in people experiencing infertility: the protocol for an exploratory randomised controlled trial (MoMiFer-RCT). BMJ Open. 2022 Feb 2;12(2):e050088. doi: 10.1136/bmjopen-2021-050088. |
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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).
Data will become available from 9-36 months after the publication of the RCT-results by the research team.
Data will only be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared to achieve aims in the approved proposal and for individual participant meta-analysis. Proposals should be directed to Katleen.vandergucht@kuleuven.be . To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Participants are randomly assigned to one of two conditions: The intervention group receives a mobile mindfulness programme (mMP). The participants in the control group are wait-listed. They will receive access to the mobile mindfulness programme after three months.
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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) |
| 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) | 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) | 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) | 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) | 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 | After 1.5 and 3 months in the intervention group |