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InfertilityMoMiFerNCT04143828

A Mobile Mindfulness Programme for Individuals/Couples Experiencing Fertility Problems

A study testing mobile mindfulness programme in people with Infertility, run by KU Leuven at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 43 years
Conditions the study is for
Infertility
What is being tested?
mobile mindfulness programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBelgium
Study dates
24 Nov 2019to May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 43 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Not applicable

Trial locations and contacts

1 site in 1 country.

Katleen Van der Gucht, PhD contact

+3216373183

katleen.vandergucht@kuleuven.be

Tessy Boedt, MSc. contact

+32486804604

tessy.boedt@kuleuven.be

Belgium1 site, 1 recruiting

  • KU Leuven

    Leuven, Vlaams-Brabant, 3000

    Katleen Van der Gucht, PhD, +32 16 37 31 83, katleen.vandergucht@kuleuven.be

    Recruiting

Other trials in Belgium

About this study

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

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.

Conditions
Infertility
Being tested
mobile mindfulness programme
Keywords
Infertility, Mobile Health, Mindfulness
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mobile mindfulness programmeBehavioural

    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.

Study groups in NCT04143828
Study groupRoleWhat they receive
Mobile Mindfulness ProgrammeExperimentalThe mobile mindfulness program is delivered via a mobile application.
Receives: Behavioral: mobile mindfulness programme
Wait-list control conditionNo interventionWhen 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Data collected at baseline (before randomisation), after 1.5 and 3 months

  2. 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)

    Measured: Data collected at baseline (before randomisation), after 1.5 and 3 months

Secondary outcomes (7)

  1. repetitive negative thoughts

    Change in scores on the Perseverative Thinking Questionnaire (PTQ) - 15 items; scoring: 0-60 (the higher, the more repetitive negative thinking)

    Measured: Data collected at baseline (before randomisation), after 1.5 and 3 months

  2. 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)

    Measured: Data collected at baseline (before randomisation), after 1.5 and 3 months

  3. self-compassion

    Change in scores on the Self Compassion Scale (SCS-NL-R) - 12 items; scoring: 12-60 (the higher the more self-compassion)

    Measured: Data collected at baseline (before randomisation), after 1.5 and 3 months

  4. Emotional distress

    Change in scores on the Depression, Anxiety and Stress Scale (DASS-21); scoring: 0-126 (the higher the more emotional distress)

    Measured: Data collected at baseline (before randomisation), after 1,5 and 3 months

  5. 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)

    Measured: Data collected at baseline (before randomisation), after 1,5 and 3 months

  6. 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)

    Measured: after 3 months in the intervention group

  7. 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

    Measured: After 1.5 and 3 months in the intervention group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start24 Nov 2019
  3. Primary completionMay 2021 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04143828
Sponsor's protocol ID
S62323
Acronym
MoMiFer
Status last verified
Apr 2020
First submitted
25 Oct 2019
Last updated
7 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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).

Publications

  • 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.

    PubMed 35110309

Questions about this trial

What is this clinical trial studying?

A study testing mobile mindfulness programme in people with Infertility, run by KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Katleen Van der Gucht, PhD (+3216373183, katleen.vandergucht@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fertility related quality of life (time frame: Data collected at baseline (before randomisation), after 1.5 and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04143828, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.

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MoMiFer Clinical Trial NCT04143828 | AzTrials