NCT03723018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
605

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

September 5, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2021

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

October 23, 2018

Last Update Submit

June 8, 2021

Conditions

Genetic Counseling Profession

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Other dimensions of professional well-being: Stress (genetic counselors only)

    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 at the end of the intervention period, typically 8 weeks after starting the study.

  • Other dimensions of professional well-being: Reactive distress

    Measured at the end of the intervention period, typically 8 weeks after starting the study.

  • Other dimensions of professional well-being: Resilience

    Measured at the end of the intervention period, typically 8 weeks after starting the study.

  • Determinants of counseling effectiveness: Cognitive empathy

    Measured at the end of the intervention period, typically 8 weeks after starting the study.

  • +7 more secondary outcomes

Study Arms (3)

Meditation - Headspace

EXPERIMENTAL

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

Meditation - Respite

EXPERIMENTAL

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

Observational

NO INTERVENTION

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.

Interventions

MeditationBEHAVIORAL

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

Meditation - HeadspaceMeditation - Respite

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Living outside the US

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related 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.

    PMID: 29502147BACKGROUND

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Colleen Caleshu

    Stanford University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator analyzing the data will be blinded to which study arm participants were assigned to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 29, 2018

Study Start

September 5, 2019

Primary Completion

January 11, 2021

Study Completion

May 14, 2021

Last Updated

June 9, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)