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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT03723018
Collaborator
(none)
605
1
3
20.3
29.8

Study Details

Study Description

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
  • Behavioral: Meditation
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
605 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
Actual Study Start Date :
Sep 5, 2019
Actual Primary Completion Date :
Jan 11, 2021
Actual Study Completion Date :
May 14, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Burnout (genetic counselors) [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) [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) [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Genetic counselors who provide direct clinical care

  • Genetic counseling students

  • Self-reported fluency in English

Exclusion Criteria:
  • Living outside the US

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Study Director: Colleen Caleshu, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Maryann W Campion, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT03723018
Other Study ID Numbers:
  • IRB-48456
First Posted:
Oct 29, 2018
Last Update Posted:
Jun 9, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 9, 2021