A Mobile Mindfulness Programme for Individuals/Couples Experiencing Fertility Problems

NCT04143828 | Unknown

• 1 other identifier: S62323
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Infertility; Mobile Health; Mindfulness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• repetitive negative thoughts

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

• mindfulness skills

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

• self-compassion

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

• Emotional distress

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

• Mindfulness skills

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

Study Arms (2)

Mobile Mindfulness Programme

EXPERIMENTAL

The mobile mindfulness program is delivered via a mobile application.

Behavioral: mobile mindfulness programme

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.

Interventions

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.

Mobile Mindfulness Programme

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• KU Leuven: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 35110309 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Sharon Lie Fong, MD. PhD.

  KU Leuven, UZ Leuven

  PRINCIPAL INVESTIGATOR

• Filip Raes, PhD

  Leuven Mindfulness Centre - KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katleen Van der Gucht, PhD

CONTACT

+3216373183; katleen.vandergucht@kuleuven.be

Tessy Boedt, MSc.

CONTACT

+32486804604; tessy.boedt@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Senior Investigator at Leuven Mindfulness Centre - KU Leuven

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: November 24, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will become available from 9-36 months after the publication of the RCT-results by the research team.
• Access Criteria: 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.

Locations

BE (1)