Psychological StressSFN-NursesNCT01796054
Stress Free Now, a Mind-body Reduction Program for Nurses
A study testing Stress Free Now online program and Group support session in people with Psychological Stress and Anxiety, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Mindful meditation sessions have been associated with an improvement in mindfulness, perceived stress, psychological well-being, anxiety, hostility, and depression. Meditation has been associated with a decrease in autonomic sympathetic activity, heart rate, oxygen consumption and energy expenditure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Stress, Anxiety, Depression
- What is being tested?
- Stress Free Now online program and Group support session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Aug 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 18 years of age
- work as a full-time or part-time nurse at Cleveland Clinic
- have regular internet and email access and be willing and able to attend group support sessions
- work at least one weekday during the week in order to attend orientation and/or group support sessions
Who cannot join
- participating in another stress reduction research study
- pregnant, lactating, or planning to be pregnant in the next 6 months
- hospitalized for depression in past 12 months
- vacation time away from work for more than 1 week during the first 2 months of the study
- current diagnosis of schizophrenia, other psychotic or bipolar disorder
- other medial, psychiatric, or behavioral limitations that may interfere with study participation or the ability to follow the intervention protocol
- unwilling or uninterested in participating in group sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Mind-body Stress Reduction Program for Nurses: A Randomized Controlled Study
Mindful meditation sessions have been associated with an improvement in mindfulness, perceived stress, psychological well-being, anxiety, hostility, and depression. Meditation has been associated with a decrease in autonomic sympathetic activity, heart rate, oxygen consumption and energy expenditure. Randomized controlled trials of online mindfulness and relaxation programs have been studied in patients with conditions such as irritable bowel syndrome, headache, depression, fibromyalgia, and insomnia. Nurses may benefit from such programs given levels of job stress. This study will determine whether an online stress reduction program that incorporates meditation with and without concomitant group support reduces burnout among nurses, including emotional exhaustion and depersonalization. The proposed research study will utilize Stress Free Now, an online stress reduction program developed by Cleveland Clinic Wellness Institute.
Read the detailed description
This is a randomized, controlled, single-center research study of an online intervention with peer group support to reduce stress in nurses. All participants will be assigned to the intervention or control groups by random number allocation. The duration of the intervention is 6 weeks; follow-up is at 6 and 24 weeks; the duration of the study is 6 months (24 weeks). Total individual participant time commitment will depend on particular intervention or control group assignment. Both intervention and control groups will be requested to complete a set of questionnaires at weeks 0, 6, and 24. The questionnaires will take an estimated 45 minutes to complete.
- Conditions
- Psychological Stress, Anxiety, Depression
- Being tested
- Stress Free Now online program, Group support session
- Keywords
- Perceived stress, Burnout, Mindfulness, Intent to leave nursing
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Depression, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Free Now online programBehavioural
Stress Free Now is an online stress reduction program. Participants will log into online program, read and practice daily and weekly activities.
Group support sessionBehavioural
Participants will meet weekly for group support session to review online lessons and relaxation therapies.
| Study group | Role | What they receive |
|---|---|---|
| Stress Free Now with group support | Experimental | Randomized participants have access to online stress reduction program, Stress Free Now. Participants will log in to online program, read daily lessons and practice therapeutic exercises. They will also attend weekly group support session during 6-week program Receives: Behavioral: Stress Free Now online program; Behavioral: Group support session |
| Stress Free Now | Experimental | Randomized participants have access to online stress reduction program, Stress Free Now, for 6 weeks. Participants will log into online program, read daily lessons and practice therapeutic exercises. Receives: Behavioral: Stress Free Now online program |
| Control | No intervention | Randomized participants do not have access to online stress reduction program, Stress Free Now, nor do they attend weekly group support sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout
Measured by Maslach Burnout Inventory Human Services Survey
Measured: 24 weeks
Secondary outcomes (7)
Perceived stress
Measured by Perceived Stress Scale
Measured: 24 weeks
Self-reported BMI
Measured: 24 weeks
Emotional well-being
Measured by RAND Short-Form (SF)-36
Measured: 24 weeks
Insomnia
Measured: 24 weeks
Psychosomatic symptoms
Measured by Psychosomatic Symptoms Checklist
Measured: 24 weeks
Mindfulness
Measured by Five Factor Mindfulness Questionnaire
Measured: 24 weeks
Intent to leave nursing
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 posted21 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by The Cleveland 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Libertini, The Cleveland Clinic
- Investigators
- Adam Bernstein, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796054
- Sponsor's protocol ID
- 12-1398
- Acronym
- SFN-Nurses
- Status last verified
- May 2022
- First submitted
- 15 Feb 2013
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mind-body Stress Reduction Program for Nurses: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01796054
- Acronym / sponsor ID
- SFN-Nurses / 12-1398
- Conditions
- Psychological Stress, Anxiety, Depression
- Keywords
- Perceived stress, Burnout, Mindfulness, Intent to leave nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Feb 2013 (estimated)
- 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.
Mindful meditation sessions have been associated with an improvement in mindfulness, perceived stress, psychological well-being, anxiety, hostility, and depression. Meditation has been associated with a decrease in autonomic sympathetic activity, heart rate, oxygen consumption and energy expenditure. Randomized controlled trials of online mindfulness and relaxation programs have been studied in patients with conditions such as irritable bowel syndrome, headache, depression, fibromyalgia, and insomnia. Nurses may benefit from such programs given levels of job stress. This study will determine whether an online stress reduction program that incorporates meditation with and without concomitant group support reduces burnout among nurses, including emotional exhaustion and depersonalization. The proposed research study will utilize Stress Free Now, an online stress reduction program developed by Cleveland Clinic Wellness Institute.
Detailed description
This is a randomized, controlled, single-center research study of an online intervention with peer group support to reduce stress in nurses. All participants will be assigned to the intervention or control groups by random number allocation. The duration of the intervention is 6 weeks; follow-up is at 6 and 24 weeks; the duration of the study is 6 months (24 weeks). Total individual participant time commitment will depend on particular intervention or control group assignment. Both intervention and control groups will be requested to complete a set of questionnaires at weeks 0, 6, and 24. The questionnaires will take an estimated 45 minutes to complete.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stress Free Now with group support | Experimental | Behavioral: Stress Free Now online program, Behavioral: Group support sessionRandomized participants have access to online stress reduction program, Stress Free Now. Participants will log in to online program, read daily lessons and practice therapeutic exercises. They will also attend weekly group support session during 6-week program |
| Stress Free Now | Experimental | Behavioral: Stress Free Now online programRandomized participants have access to online stress reduction program, Stress Free Now, for 6 weeks. Participants will log into online program, read daily lessons and practice therapeutic exercises. |
| Control | No intervention | –Randomized participants do not have access to online stress reduction program, Stress Free Now, nor do they attend weekly group support sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be at least 18 years of age
- work as a full-time or part-time nurse at Cleveland Clinic
- have regular internet and email access and be willing and able to attend group support sessions
- work at least one weekday during the week in order to attend orientation and/or group support sessions
Key exclusion criteria (7 listed)
- participating in another stress reduction research study
- pregnant, lactating, or planning to be pregnant in the next 6 months
- hospitalized for depression in past 12 months
- vacation time away from work for more than 1 week during the first 2 months of the study
- current diagnosis of schizophrenia, other psychotic or bipolar disorder
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 |
|---|---|---|
| Stress Free Now online programStress Free Now is an online stress reduction program. Participants will log into online program, read and practice daily and weekly activities. | Behavioural | Stress Free Now, Stress Free Now with group support |
| Group support sessionParticipants will meet weekly for group support session to review online lessons and relaxation therapies. | Behavioural | Stress Free Now with group support |
Primary outcome
Burnout
Time frame: 24 weeks
Measured by Maslach Burnout Inventory Human Services Survey
7 secondary outcomes
Perceived stress
Time frame: 24 weeks
Self-reported BMI
Time frame: 24 weeks
Emotional well-being
Time frame: 24 weeks
Insomnia
Time frame: 24 weeks
Psychosomatic symptoms
Time frame: 24 weeks
Mindfulness
Time frame: 24 weeks
Intent to leave nursing
Time frame: 24 weeks
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 11 May 2022.
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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.
Adam Bernstein, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Free Now online program and Group support session in people with Psychological Stress and Anxiety, run by The Cleveland Clinic 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 4 inclusion and 7 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 11 May 2022. 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 (time frame: 24 weeks). 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 11 May 2022.