Clinical trial NCT03723018: Me-GC: A Randomized Controlled Trial of Meditation for Genetic Counselors
Official title: Me-GC: A Randomized Controlled Trial of Meditation to Reduce Genetic Counselor Burnout and Genetic Counseling Student Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genetic Counseling Profession
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 605
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Living outside the US

Primary outcomes:
measure: Burnout (genetic counselors)
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
measure: Stress (genetic counseling students)
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
Secondary outcomes:
measure: Other dimensions of professional well-being: Stress (genetic counselors only)
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
measure: Other dimensions of professional well-being: Professional fulfillment (genetic counselors only)
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
measure: Other dimensions of professional well-being: Reactive distress
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
measure: Other dimensions of professional well-being: Resilience
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
measure: Determinants of counseling effectiveness: Cognitive empathy
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
measure: Determinants of counseling effectiveness: Affective empathy
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
measure: Determinants of counseling effectiveness: Working alliance
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
measure: Determinants of counseling effectiveness: Empathic understanding
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
measure: Determinants of counseling effectiveness: Unconditional positive regard
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
measure: Determinants of counseling effectiveness: Non-judging
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
measure: Determinants of counseling effectiveness: Non-reactivity
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
measure: Retention in clinical roles
timeFrame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Colleen Caleshu
role: STUDY_DIRECTOR
References:
citation: 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.