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

Genetic Counseling Profession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723018
• Other study ID #: IRB-48456
• Status: Completed
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: May 14, 2021

Study information

• Verified date: June 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: May 14, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Genetic counselors who provide direct clinical care

• Genetic counseling students

• Self-reported fluency in English

Exclusion Criteria:

• Living outside the US

Related Conditions & MeSH terms

• Genetic Counseling Profession

Intervention

Behavioral:
• Meditation
10 minutes a day of meditation, done on your own time.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Silver J, Caleshu C, Casson-Parkin S, Ormond K. Mindfulness Among Genetic Counselors Is Associated with Increased Empathy and Work Engagement and Decreased Burnout and Compassion Fatigue. J Genet Couns. 2018 Sep;27(5):1175-1186. doi: 10.1007/s10897-018-0236-6. Epub 2018 Mar 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burnout (genetic counselors)	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.
Primary	Stress (genetic counseling students)	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	Other dimensions of professional well-being: Stress (genetic counselors only)	Measured with the Perceived Stress Scale	Measured at the end of the intervention period, typically 8 weeks after starting the study.
Secondary	Other dimensions of professional well-being: Professional fulfillment (genetic counselors only)	Measured with the Professional Fulfillment Index	Measured at the end of the intervention period, typically 8 weeks after starting the study.
Secondary	Other dimensions of professional well-being: Reactive distress	Measured with the Interpersonal Reactivity Index	Measured at the end of the intervention period, typically 8 weeks after starting the study.
Secondary	Other dimensions of professional well-being: Resilience	Measured with the Connor-Davidson Resilience Scale-10	Measured at the end of the intervention period, typically 8 weeks after starting the study.
Secondary	Determinants of counseling effectiveness: Cognitive empathy	Measured with the Interpersonal Reactivity Index	Measured at the end of the intervention period, typically 8 weeks after starting the study.
Secondary	Determinants of counseling effectiveness: Affective empathy	Measured with the Interpersonal Reactivity Index	Measured at the end of the intervention period, typically 8 weeks after starting the study.
Secondary	Determinants of counseling effectiveness: Working alliance	Measured with the Working Alliance Inventory	Measured at the end of the intervention period, typically 8 weeks after starting the study.
Secondary	Determinants of counseling effectiveness: Empathic understanding	Measured with the Barrett-Lennard Relationship Inventory	Measured at the end of the intervention period, typically 8 weeks after starting the study.
Secondary	Determinants of counseling effectiveness: Unconditional positive regard	Measured with the Barrett-Lennard Relationship Inventory	Measured at the end of the intervention period, typically 8 weeks after starting the study.
Secondary	Determinants of counseling effectiveness: Non-judging	Measured with the Five-Facet Mindfulness Questionnaire	Measured at the end of the intervention period, typically 8 weeks after starting the study.
Secondary	Determinants of counseling effectiveness: Non-reactivity	Measured with the Five-Facet Mindfulness Questionnaire	Measured at the end of the intervention period, typically 8 weeks after starting the study.
Secondary	Retention in clinical roles	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.