A Mobile Mindfulness Programme for Individuals/Couples Experiencing Fertility Problems

NCT ID: NCT04143828

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-24

Study Completion Date

2021-05-31

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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mobile Mindfulness Programme

The mobile mindfulness program is delivered via a mobile application.

Group Type EXPERIMENTAL

mobile mindfulness programme

Intervention Type 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.

Wait-list control condition

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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mobile mindfulness programme

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Katleen Van der Gucht

PhD, Senior Investigator at Leuven Mindfulness Centre - KU Leuven

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharon Lie Fong, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven, UZ Leuven

Filip Raes, PhD

Role: PRINCIPAL_INVESTIGATOR

Leuven Mindfulness Centre - KU Leuven

Locations

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KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Katleen Van der Gucht, PhD

Role: CONTACT

+3216373183

Tessy Boedt, MSc.

Role: CONTACT

+32486804604

Facility Contacts

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Katleen Van der Gucht, PhD

Role: primary

+32 16 37 31 83

References

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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.

Reference Type DERIVED
PMID: 35110309 (View on PubMed)

Other Identifiers

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S62323

Identifier Type: -

Identifier Source: org_study_id

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