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

June 8, 2021 updated by: Maryann W Campion, Stanford University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

605

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Living outside the US

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.
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
Measured at the end of the intervention period, typically 8 weeks after starting the study.
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.
Measured at the end of the intervention period, typically 8 weeks after starting the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Study Director: Colleen Caleshu, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 5, 2019

Primary Completion (ACTUAL)

January 11, 2021

Study Completion (ACTUAL)

May 14, 2021

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (ACTUAL)

October 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-48456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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