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Completed

NCT Number: NCT03723018

Me-GC: A Randomized Controlled Trial of Meditation for Genetic Counselors

This study is designed to determine whether meditation is beneficial for genetic counselors and genetic counseling students. The main goal is to see if meditation can help with professional well-being (burnout for genetic counselors, stress for genetic counseling students). The investigators will also explore whether meditation has other benefits for the genetic counseling profession.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

The investigators will recruit 390-420 genetic counselors and 189-210 genetic counseling students. Participants will be randomized into one of three groups of roughly the same size: two meditation groups and an observational group. All three groups will fill out online surveys at several points in the study. The only thing the observational group will be asked to do is fill out these surveys. The meditation groups will be asked to meditate for 10 minutes a day for 8 weeks. Participants will be provided with an app or website that instructs them on how to meditate.

Outcome analyses will be done with an intention to treat approach. Outcomes will be assessed using linear regression with the outcome variable as the dependent variable and baseline outcome measure, baseline mindfulness, and treatment group as the independent variables. Secondary outcomes will be considered exploratory.

The study is funded by the Jane Engelberg Memorial Foundation

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Genetic counselors who provide direct clinical care
  • Genetic counseling students
  • Self-reported fluency in English

Exclusion criteria

  • Living outside the US

Treatment and study plan

Meditation

Behavioral

10 minutes a day of meditation, done on your own time.

Primary outcomes

  1. Burnout (genetic counselors)

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    The primary outcome for genetic counselors is burnout, measured with the Professional Fulfillment Inventory

  2. Stress (genetic counseling students)

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    The primary outcome for genetic counseling students is stress, measured with the Perceived Stress Scale

Secondary outcomes

  1. Other dimensions of professional well-being: Stress (genetic counselors only)

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    Measured with the Perceived Stress Scale

  2. Other dimensions of professional well-being: Professional fulfillment (genetic counselors only)

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    Measured with the Professional Fulfillment Index

  3. Other dimensions of professional well-being: Reactive distress

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    Measured with the Interpersonal Reactivity Index

  4. Other dimensions of professional well-being: Resilience

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    Measured with the Connor-Davidson Resilience Scale-10

  5. Determinants of counseling effectiveness: Cognitive empathy

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    Measured with the Interpersonal Reactivity Index

  6. Determinants of counseling effectiveness: Affective empathy

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    Measured with the Interpersonal Reactivity Index

  7. Determinants of counseling effectiveness: Working alliance

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    Measured with the Working Alliance Inventory

  8. Determinants of counseling effectiveness: Empathic understanding

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    Measured with the Barrett-Lennard Relationship Inventory

  9. Determinants of counseling effectiveness: Unconditional positive regard

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    Measured with the Barrett-Lennard Relationship Inventory

  10. Determinants of counseling effectiveness: Non-judging

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    Measured with the Five-Facet Mindfulness Questionnaire

  11. Determinants of counseling effectiveness: Non-reactivity

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    Measured with the Five-Facet Mindfulness Questionnaire

  12. Retention in clinical roles

    Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.

    Retention in clinical roles, measured we will measure intention to reduce clinical load, using a custom item with a visual analogue scale.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Me-GC: A Randomized Controlled Trial of Meditation to Reduce Genetic Counselor Burnout and Genetic Counseling Student Stress

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2018
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.