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

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ClinicalTrials.gov Identifier: NCT03723018
Recruitment Status : Not yet recruiting
First Posted : October 29, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Maryann W Campion, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Genetic Counseling Profession Behavioral: Meditation Not Applicable

Detailed Description:

The investigators will recruit 210 genetic counselors and 132 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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The investigator analyzing the data will be blinded to which study arm participants were assigned to.
Primary Purpose: Treatment
Official Title: Me-GC: A Randomized Controlled Trial of Meditation to Reduce Genetic Counselor Burnout and Genetic Counseling Student Stress
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Meditation - Headspace
Participants in this arm will be asked to meditate daily for 10 minutes for 8 weeks. Meditation instruction will be provided by the commercially available app/website Headspace (provided to participants for free). Participants in this arm will have access to the other meditation arm once they finish the study.
Behavioral: Meditation
10 minutes a day of meditation, done on your own time.

Experimental: Meditation - Respite
Participants in this arm will be asked to meditate daily for 10 minutes for 8 weeks. Meditation instruction will be provided by Respite, a website created by the investigators for this study. Participants in this arm will have access to the other meditation arm once they finish the study.
Behavioral: Meditation
10 minutes a day of meditation, done on your own time.

No Intervention: Observational
Participants in this arm will not receive any intervention. Their only study activity will be taking online surveys. They will have access to the two meditation arms once they finish the study.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Living outside the US

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723018


Contacts
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Contact: Colleen Caleshu 650.725.6273 ccaleshu@stanfordhealthcare.org
Contact: MaryAnn Campion mcampion@stanford.edu

Sponsors and Collaborators
Stanford University
Investigators
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Study Director: Colleen Caleshu Stanford University

Publications:
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Responsible Party: Maryann W Campion, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03723018     History of Changes
Other Study ID Numbers: IRB-48456
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No