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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Genetic Counseling Profession

Intervention / Treatment
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* Behavioral: Meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Genetic counselors who provide direct clinical care Genetic counseling students Self-reported fluency in English Exclusion Criteria: Living outside the US
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation - Headspace<br>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<br>* 10 minutes a day of meditation, done on your own time.<br>|
| Experimental: Meditation - Respite<br>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<br>* 10 minutes a day of meditation, done on your own time.<br>|
| No Intervention: Observational<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |