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

NCT ID: NCT03723018

Last Updated: 2021-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

605 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-05

Study Completion Date

2021-05-14

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

Conditions

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Genetic Counseling Profession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The investigator analyzing the data will be blinded to which study arm participants were assigned to.

Study Groups

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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.

Group Type EXPERIMENTAL

Meditation

Intervention Type BEHAVIORAL

10 minutes a day of meditation, done on your own time.

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.

Group Type EXPERIMENTAL

Meditation

Intervention Type BEHAVIORAL

10 minutes a day of meditation, done on your own time.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Meditation

10 minutes a day of meditation, done on your own time.

Intervention Type BEHAVIORAL

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Maryann W Campion

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Colleen Caleshu

Role: STUDY_DIRECTOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29502147 (View on PubMed)

Other Identifiers

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IRB-48456

Identifier Type: -

Identifier Source: org_study_id

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