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

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ClinicalTrials.gov Identifier: NCT03723018
Recruitment Status : Not yet recruiting
First Posted : October 29, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Maryann W Campion, Stanford University

Tracking Information
First Submitted Date  ICMJE October 23, 2018
First Posted Date  ICMJE October 29, 2018
Last Update Posted Date December 31, 2018
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • Burnout (genetic counselors) [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    The primary outcome for genetic counselors is burnout, measured with the Professional Fulfillment Inventory
  • Stress (genetic counseling students) [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    The primary outcome for genetic counseling students is stress, measured with the Perceived Stress Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03723018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • Other dimensions of professional well-being: Stress (genetic counselors only) [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    Measured with the Perceived Stress Scale
  • Other dimensions of professional well-being: Professional fulfillment (genetic counselors only) [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    Measured with the Professional Fulfillment Index
  • Other dimensions of professional well-being: Reactive distress [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    Measured with the Interpersonal Reactivity Index
  • Other dimensions of professional well-being: Resilience [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    Measured with the Connor-Davidson Resilience Scale-10
  • Determinants of counseling effectiveness: Cognitive empathy [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    Measured with the Interpersonal Reactivity Index
  • Determinants of counseling effectiveness: Affective empathy [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    Measured with the Interpersonal Reactivity Index
  • Determinants of counseling effectiveness: Working alliance [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    Measured with the Working Alliance Inventory
  • Determinants of counseling effectiveness: Empathic understanding [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    Measured with the Barrett-Lennard Relationship Inventory
  • Determinants of counseling effectiveness: Unconditional positive regard [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    Measured with the Barrett-Lennard Relationship Inventory
  • Determinants of counseling effectiveness: Non-judging [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    Measured with the Five-Facet Mindfulness Questionnaire
  • Determinants of counseling effectiveness: Non-reactivity [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    Measured with the Five-Facet Mindfulness Questionnaire
  • Retention in clinical roles [ Time Frame: Measured at the end of the intervention period, typically 8 weeks after starting the study. ]
    Retention in clinical roles, measured we will measure intention to reduce clinical load, using a custom item with a visual analogue scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Me-GC: A Randomized Controlled Trial of Meditation for Genetic Counselors
Official Title  ICMJE Me-GC: A Randomized Controlled Trial of Meditation to Reduce Genetic Counselor Burnout and Genetic Counseling Student Stress
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 210 genetic counselors and 132 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description:
The investigator analyzing the data will be blinded to which study arm participants were assigned to.
Primary Purpose: Treatment
Condition  ICMJE Genetic Counseling Profession
Intervention  ICMJE Behavioral: Meditation
10 minutes a day of meditation, done on your own time.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Meditation
  • Experimental: 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.
    Intervention: Behavioral: Meditation
  • No Intervention: 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2018)
342
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Living outside the US
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Colleen Caleshu 650.725.6273 ccaleshu@stanfordhealthcare.org
Contact: MaryAnn Campion mcampion@stanford.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03723018
Other Study ID Numbers  ICMJE IRB-48456
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maryann W Campion, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Colleen Caleshu Stanford University
PRS Account Stanford University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP