Genetic Counseling ProfessionNCT03723018
Me-GC: A Randomized Controlled Trial of Meditation for Genetic Counselors
A study testing Meditation in people with Genetic Counseling Profession, run by Stanford University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Genetic Counseling Profession
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to 14 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Genetic counselors who provide direct clinical care
- Genetic counseling students
- Self-reported fluency in English
Who cannot join
- Living outside the US
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Me-GC: A Randomized Controlled Trial of Meditation to Reduce Genetic Counselor Burnout and Genetic Counseling Student Stress
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.
Read the 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
- Conditions
- Genetic Counseling Profession
- Being tested
- Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
10 minutes a day of meditation, done on your own time.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout (genetic counselors)
The primary outcome for genetic counselors is burnout, measured with the Professional Fulfillment Inventory
Measured: 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: 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 with the Perceived Stress Scale
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Measured at the end of the intervention period, typically 8 weeks after starting the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start5 Sep 2019
- Primary completion11 Jan 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genetic Counseling ProfessionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryann W Campion, Stanford University
- Investigators
- Colleen Caleshu, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723018
- Sponsor's protocol ID
- IRB-48456
- Status last verified
- Jun 2021
- First submitted
- 23 Oct 2018
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29502147
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Me-GC: A Randomized Controlled Trial of Meditation to Reduce Genetic Counselor Burnout and Genetic Counseling Student Stress
- ClinicalTrials.gov ID
- NCT03723018
- Acronym / sponsor ID
- IRB-48456
- Conditions
- Genetic Counseling Profession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meditation - Headspace | Experimental | Behavioral: MeditationParticipants 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. |
| Meditation - Respite | Experimental | Behavioral: MeditationParticipants 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Genetic counselors who provide direct clinical care
- Genetic counseling students
- Self-reported fluency in English
Key exclusion criteria (1 listed)
- Living outside the US
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation10 minutes a day of meditation, done on your own time. | Behavioural | Meditation - Headspace, Meditation - Respite |
Primary outcome
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
12 secondary outcomes
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.
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.
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.
Other dimensions of professional well-being: Resilience
Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
Determinants of counseling effectiveness: Cognitive empathy
Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
Determinants of counseling effectiveness: Affective empathy
Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
Determinants of counseling effectiveness: Working alliance
Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
Determinants of counseling effectiveness: Empathic understanding
Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
Determinants of counseling effectiveness: Unconditional positive regard
Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
Determinants of counseling effectiveness: Non-judging
Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
Determinants of counseling effectiveness: Non-reactivity
Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
Retention in clinical roles
Time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Background: PubMed 29502147Silver 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen Caleshu study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Genetic Counseling Profession, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burnout (genetic counselors) (time frame: Measured at the end of the intervention period, typically 8 weeks after starting the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03723018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.