A Mobile Mindfulness Programme for Individuals/Couples Experiencing Fertility Problems

Study Overview
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Brief Summary
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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.

Official Title
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MoMiFer-Study: Evaluation of a Mobile Mindfulness Program (mMP) in Individuals/Couples Experiencing Fertility Problems

Conditions
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Infertility

Intervention / Treatment
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* Behavioral: mobile mindfulness programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Mindfulness Programme<br>The mobile mindfulness program is delivered via a mobile application. | Behavioral: mobile mindfulness programme<br>* 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.<br>|
| No Intervention: Wait-list control condition<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile Health, Infertility, Mindfulness