BurnoutNCT01786499
The Effect of Relaxation Response on Provider Burnout
A study testing Relaxation Response Training in people with Burnout and Resilience, run by Allina Health System at 1 site in United States.
Trial summary
Hypothesis: Relaxation Response training is an effective intervention in reducing the prevalence and severity of burnout and its components from baseline levels among physicians receiving the training intervention. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Resilience, Perceived Stress
- What is being tested?
- Relaxation Response Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2013
- 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
- Providers at designated clinic and hospital
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis: Relaxation Response training is an effective intervention in reducing the prevalence and severity of burnout and its components from baseline levels among physicians receiving the training intervention. The intervention is hypothesized to moderate the relationship between Areas of Worklife (AWS) and burnout by improving physician's ability to cope with the demands of their workplace. This increased coping ability is hypothesized to reduce burnout.
Physician practices are as unique as the individual practitioners and the environment in which they practice. Traditional instruction of relaxation or self-care techniques has required participants to travel to locations remote from the workplace. The time commitment required for this behavior is additive to the time required to learn the intervention and of itself may induce extra stress increasing the potential for burnout. This study proposes that bringing the intervention to the workplace will increase provider willingness to participate and diminish the stress introduced by deployment of the intervention. Since inpatient and outpatient medicine have different practice characteristics and demands on the time of the practitioners, this study will need to develop and test the logistics necessary to bring the training to the different physician populations.
- Conditions
- Burnout, Resilience, Perceived Stress
- Being tested
- Relaxation Response Training
- Keywords
- Burnout, Stress, Provider, Relaxation Response
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation Response TrainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Relaxation Response Training | Other | Not described Receives: Behavioral: Relaxation Response Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in burnout expression in study population
Measurement strategy: data collection at Baseline (prior to beginning of the Relaxation Response training), 3 months, 6 months, 12 months, 18 months, and 24 months after implementation.
Measurement instruments: survey that measures prevalence and severity of burnout (Maslach Burnout Inventory, MBI), the proximate drivers of burnout (Areas of Worklife Survey), an assessment of the perceived stress experienced by the practitioners (Perceived Stress Scale), and a measure of the personal resilience (Conor-Davidson Resilience Scale). Standard univariate statistics will be used to produce descriptive measures of the sample, Chronbach's alpha to assess internal reliability of survey measures, and confirmatory factor analysis will be employed to determine if the data fits the a priori theoretical model. A combination of the approaches above will help to assess the effectiveness of the Relaxation Response intervention on the prevalence, incidence, and trajectory of provider burnout.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnoutStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786499
- Sponsor's protocol ID
- 3888-2
- Status last verified
- Nov 2016
- First submitted
- 5 Feb 2013
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Benson H, Greenwood MM, Klemchuk H. The relaxation response: psychophysiologic aspects and clinical applications. Int J Psychiatry Med. 1975;6(1-2):87-98. doi: 10.2190/376W-E4MT-QM6Q-H0UM.
PubMed 773864Leiter, M. P., & Maslach, C. (2004). Areas of worklife: A structured approach to organizational predictors of job burnout. Research in Occupational Stress and Well being: Emotional and Physiological Processes and Positive Intervention Strategies, 3, 92-134.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Relaxation Response on Provider Burnout
- ClinicalTrials.gov ID
- NCT01786499
- Acronym / sponsor ID
- 3888-2
- Conditions
- Burnout, Resilience, Perceived Stress
- Keywords
- Burnout, Stress, Provider, Relaxation Response
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (estimated)
- First posted
- 8 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.
Hypothesis: Relaxation Response training is an effective intervention in reducing the prevalence and severity of burnout and its components from baseline levels among physicians receiving the training intervention. The intervention is hypothesized to moderate the relationship between Areas of Worklife (AWS) and burnout by improving physician's ability to cope with the demands of their workplace. This increased coping ability is hypothesized to reduce burnout.
Physician practices are as unique as the individual practitioners and the environment in which they practice. Traditional instruction of relaxation or self-care techniques has required participants to travel to locations remote from the workplace. The time commitment required for this behavior is additive to the time required to learn the intervention and of itself may induce extra stress increasing the potential for burnout. This study proposes that bringing the intervention to the workplace will increase provider willingness to participate and diminish the stress introduced by deployment of the intervention. Since inpatient and outpatient medicine have different practice characteristics and demands on the time of the practitioners, this study will need to develop and test the logistics necessary to bring the training to the different physician populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relaxation Response Training | Other | Behavioral: Relaxation Response Training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Providers at designated clinic and hospital
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Relaxation Response Training | Behavioural | Relaxation Response Training |
Primary outcome
Change in burnout expression in study population
Time frame: Three months
Measurement strategy: data collection at Baseline (prior to beginning of the Relaxation Response training), 3 months, 6 months, 12 months, 18 months, and 24 months after implementation. Measurement instruments: survey that measures prevalence and severity of burnout (Maslach Burnout Inventory, MBI), the proximate drivers of burnout (Areas of Worklife Survey), an assessment of the perceived stress experienced by the practitioners (Perceived Stress Scale), and a measure of the personal resilience (Conor-Davidson Resilience Scale). Standard univariate statistics will be used to produce descriptive measures of the sample, Chronbach's alpha to assess internal reliability of survey measures, and confirmatory factor analysis will be employed to determine if the data fits the a priori theoretical model. A combination of the approaches above will help to assess the effectiveness of the Relaxation Response intervention on the prevalence, incidence, and trajectory of provider burnout.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Background: PubMed 773864Benson H, Greenwood MM, Klemchuk H. The relaxation response: psychophysiologic aspects and clinical applications. Int J Psychiatry Med. 1975;6(1-2):87-98. doi: 10.2190/376W-E4MT-QM6Q-H0UM.
- BackgroundLeiter, M. P., & Maslach, C. (2004). Areas of worklife: A structured approach to organizational predictors of job burnout. Research in Occupational Stress and Well being: Emotional and Physiological Processes and Positive Intervention Strategies, 3, 92-134.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Response Training in people with Burnout and Resilience, run by Allina Health System 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 1 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: withdrawn, as of the sponsor's last update on 1 Dec 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in burnout expression in study population (time frame: Three months). 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 NCT01786499, which also lists 2 linked publications.
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 1 Dec 2016.