StressNCT03616756
Authentic Connections for Nurse Leaders
A study testing Authentic Connections and Protected time in people with Stress, run by Mayo Clinic at 3 sites in United States.
Trial summary
The purpose of this pilot study is to test the feasibility and outcomes of a supportive group-based intervention, Authentic Connections, to be used for nurse leaders at Mayo Clinic, Rochester, in a collaboration involving faculty at Arizona State University (ASU) Department of Psychology, Dr. Sunyia Luthar. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Authentic Connections and Protected time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Aug 2018to 2 Sep 2019
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
- In an Nursing Education Specialist (NES) or Clinical Nurse Specialist (CNS) nurse leader role at Mayo Clinic Rochester
- Female gender
- A mother to at least one child or adult child
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Fostering Resilience Amongst Mothers Under Stress: Authentic Connections for Nurse Leaders
The purpose of this pilot study is to test the feasibility and outcomes of a supportive group-based intervention, Authentic Connections, to be used for nurse leaders at Mayo Clinic, Rochester, in a collaboration involving faculty at Arizona State University (ASU) Department of Psychology, Dr. Sunyia Luthar.
- Conditions
- Stress
- Being tested
- Authentic Connections, Protected time
- Keywords
- Nurse leader, Resilience, Parenting, Stress, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Authentic ConnectionsBehavioural
Authentic Connections support groups for nurse leaders who are also mothers. Meetings occur once a week for one hour.
Protected timeBehavioural
Participants have one hour per week protected time scheduled on their calendar to do with what they choose.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Authentic Connections |
| Control group | Active comparator | Not described Receives: Behavioral: Protected time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Connor-Davidson Resilience Scale - 2 item
Two item scale, each of which has a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The total score ranges from 0-8, with higher scores reflecting greater resilience.
Measured: Baseline
Connor-Davidson Resilience Scale - 2 item
Two item scale, each of which has a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The total score ranges from 0-8, with higher scores reflecting greater resilience.
Measured: 12 weeks
Connor-Davidson Resilience Scale - 2 item
Two item scale, each of which has a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The total score ranges from 0-8, with higher scores reflecting greater resilience.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start8 Aug 2018
- Primary completion2 Sep 2019
- Study completion2 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Sherry S. Chesak, Mayo Clinic
- Investigators
- Sherry S Chesak, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616756
- Sponsor's protocol ID
- 18-002750
- Status last verified
- Jan 2020
- First submitted
- 25 Jul 2018
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Resilience Amongst Mothers Under Stress: Authentic Connections for Nurse Leaders
- ClinicalTrials.gov ID
- NCT03616756
- Acronym / sponsor ID
- 18-002750
- Conditions
- Stress
- Keywords
- Nurse leader, Resilience, Parenting, Stress, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 6 Aug 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.
The purpose of this pilot study is to test the feasibility and outcomes of a supportive group-based intervention, Authentic Connections, to be used for nurse leaders at Mayo Clinic, Rochester, in a collaboration involving faculty at Arizona State University (ASU) Department of Psychology, Dr. Sunyia Luthar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Authentic Connections |
| Control group | Active comparator | Behavioral: Protected time |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Authentic ConnectionsAuthentic Connections support groups for nurse leaders who are also mothers. Meetings occur once a week for one hour. | Behavioural | Intervention group |
| Protected timeParticipants have one hour per week protected time scheduled on their calendar to do with what they choose. | Behavioural | Control group |
Primary outcome
Connor-Davidson Resilience Scale - 2 item
Time frame: Baseline
Two item scale, each of which has a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The total score ranges from 0-8, with higher scores reflecting greater resilience.
Connor-Davidson Resilience Scale - 2 item
Time frame: 12 weeks
Two item scale, each of which has a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The total score ranges from 0-8, with higher scores reflecting greater resilience.
Connor-Davidson Resilience Scale - 2 item
Time frame: 24 weeks
Two item scale, each of which has a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The total score ranges from 0-8, with higher scores reflecting greater resilience.
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 29 Jan 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sherry S Chesak principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Authentic Connections and Protected time in people with Stress, run by Mayo Clinic at 3 sites 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?
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 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Connor-Davidson Resilience Scale - 2 item (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2020.