Burn-Out SyndromeNCT03132220
A Mindfulness Based Cognitive Therapy (MBCT) Resiliency Program for Critical Care Nurses
A study testing Mindfulness-Based Cognitive Therapy in people with Burn-Out Syndrome and Work-Related Stress Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Developed over 10 years ago, Mindfulness Based Cognitive Therapy (MBCT) synergistically combines mindfulness training and cognitive behavioral therapy and can increase resiliency. In this study, the investigators proposed two aims: Aim #1: To adapt and optimize a MBCT resiliency program specifically for ICU nurses. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn-Out Syndrome, Work-Related Stress Disorder
- What is being tested?
- Mindfulness-Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2016to 15 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ages 18 years or older
- Employed as a critical care nurse and work at least 20 hours per week as an ICU
- Baseline score of < 82 on the Connor-Davidson Resilience Scale (CD-RISC)
- Positive symptoms of at least one BOS dimension using the Maslach Burnout Inventory (MBI):
- emotional exhaustion score of >17,
- depersonalization score of >7, or
- a personal accomplishment score of < 31.
Who cannot join
- A self-reported diagnosis of:
- bipolar or psychotic disorder,
- active substance dependence, or
- immediate risk of self-harm or need for hospitalization
- Unwillingness to participate in the entire study protocol
- Employment on a time limited contract (i.e. a traveling nurse)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Denver, Colorado, 80045
About this study
Developed over 10 years ago, Mindfulness Based Cognitive Therapy (MBCT) synergistically combines mindfulness training and cognitive behavioral therapy and can increase resiliency. In this study, the investigators proposed two aims: Aim #1: To adapt and optimize a MBCT resiliency program specifically for ICU nurses. For this aim, the investigators will engage multiple stakeholder groups to assist the protocol adaptation. Aim # 2: To conduct a pilot clinical trial to determine acceptability of the MBCT resiliency program and the control intervention. In this aim, the investigators will also identify the most feasible randomization level to minimize contamination between the control and intervention groups. Collectively, this proposal will pave the way for a properly designed large multi-center trial of a MBCT resiliency program (MBCT-ICU) to determine its ability to decrease BOS symptoms; and allow nurses to more effectively care for patients in the challenging ICU environment.
Read the detailed description
The Intensive Care Unit (ICU) is a stressful environment for all critical care healthcare providers. In the United States, there are more than 500,000 critical care (ICU) nurses that treat the most seriously ill patients. These ICU nurses have especially challenging and sometimes overwhelming jobs due to high patient mortality and morbidity, and frequent encounters with ethical dilemmas. The repetitive exposure to these extreme stressors and the inability to adjust to their difficult work environment may cause significant psychological stress. The investigator's multidisciplinary research team was one of the first to identify that ICU nurses have significantly high rates of psychological distress including: symptoms of anxiety and depression, posttraumatic stress disorder (PTSD) and burnout syndrome (BOS).
Work-induced distress initiates a negative cycle that contributes to the unacceptably high ICU nursing turnover rate. Nationally, nursing turnover rates range between 17-20% per year. In the ICU, the growing nursing shortage is particularly concerning. Presently, there are no interventions to reduce BOS in ICU nurses. Many stresses on ICU nurses are inherent to the critical care environment such as performing cardiopulmonary resuscitation and the death of a patient. Therefore, the investigators multidisciplinary research group has focused on enhancing the ability of ICU nurses to adapt to their work environment.
Resiliency enables one to thrive in the face of adversity. Humans respond to stress and trauma in a variety of ways. Some people are resilient; defined as the ability to succeed, to live, and to develop in a positive way despite the stress or adversity that would normally involve the real possibility of a negative outcome. In practice, resilient individuals believe that what they do can have a positive impact on a situation, that some components of the 'system' can be controlled or influenced by one's own actions, that persistent effort is worthwhile, and that setbacks or potentially threatening events are inevitable and surmountable. A variety of qualities are associated with resiliency including the ability to engage the support of others, the belief that stress can be strengthening, and overall optimism. Though some individuals are inherently resilient; resiliency can be learned. Developing resiliency may be one strategy to prevent and treat symptoms of BOS. The investigators have demonstrated that resilient ICU nurses were less likely to have symptoms of anxiety, depression, PTSD, and BOS. The investigators also identified methods used by ICU nurses to promote resiliency and emotional wellness. The investigators ICU nursing pilot program also increased resiliency and decreased symptoms of BOS.
From the investigators prior studies, mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) are two modalities currently used by resilient ICU nurses. In the investigators most recent national survey, ICU nurses were eager to learn MBSR and CBT techniques to help reduce symptoms of BOS. Mindfulness Based Cognitive Therapy (MBCT) combines the best of MBSR and CBT, and may build resiliency and reduce BOS symptoms. MBCT was developed by integrating the framework and practices of MBSR and CBT. Classically incorporated into an 8 week course, MBCT uses mindfulness skills to help individuals become aware of negative thoughts and feelings that are activated by stress. MBCT also incorporates CBT techniques to develop a different relationship to those thoughts and feelings, and interrupt the negative thought patterns.
- Conditions
- Burn-Out Syndrome, Work-Related Stress Disorder
- Being tested
- Mindfulness-Based Cognitive Therapy, Book Club Active Control Intervention
- Keywords
- critical care nurses, mindfulness-based cognitive therapy, Burn-out Syndrome, Post-traumatic Stress Disorder, Cognitive Behavioral Therapy
- Medical subject headings
- Burnout, Psychological, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyBehavioural
Mindfulness-Based Cognitive therapy is a 16 in-person hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.
Book Club Active Control InterventionBehavioural
Participants randomized to the book club active control intervention will meet for 16 in-person hours that are broken into sessions. Books will be assigned to read during homework time and discussions regarding the books will occur during the sessions. The time involved will be similar to the MBCT intervention.
| Study group | Role | What they receive |
|---|---|---|
| Book Club Active Control | Active comparator | The subject will participate in 16 in-person hours that are broken into sessions for the book club active control intervention. This club will be facilitated by 1-2 instructors. The club will be described as a "fun activity to do outside of work to help reduce work-related stress." The club will be structured similarly to the intervention with respect to time, and homework expectations. Nurses will be prohibited from talking about work stress. Receives: Behavioral: Book Club Active Control Intervention |
| MBCT Intervention | Experimental | The subject will participate in 16 in-person hours that are broken into sessions for the Mindfulness-Based Cognitive Therapy intervention. The intervention will be facilitated by 1-2 instructors who are trained in clinical psychology/ social work and are also trained in MBCT. This intervention will include mindfulness activities, didactic learning, homework assignments and group dialogue. This adapted MBCT intervention will follow the empirically-based MBCT intervention for depression structure with fidelity. Receives: Behavioral: Mindfulness-Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Connor Davidson Resiliency Scale (CD-RISC) Scores
The primary outcome is the pre-post changes in the CD-RISC scores in intervention and control subjects. The CD-RISC scale assesses resiliency in individuals. There are 25 items in the survey, each item is scored from 0-4, and the total ranges from 0-100. Higher scores indicate increased resiliency. Any individuals who score above 81 points on this survey will not qualify for this study as they are too inherently resilient. The study intervention will typically last 4 sessions, one session per week at a total of 4 weeks.
Measured: Once before the study intervention; one time immediately following the study intervention at 4 weeks.
Secondary outcomes (10)
Changes in Acceptability of the Sessions, on the Client Satisfaction Questionnaire (CSQ-8)
This will be measured with the eight-item self-report Client Satisfaction Questionnaire (CSQ-8). This is survey has 8 items, and the total ranges from 1-32. Higher scores indicate higher satisfaction. The CSQ-8 will be administered before the intervention, weekly throughout the sessions and after the final treatment and control sessions.
Measured: Weekly during the 4 session/week intervention
Change From Baseline in Maslach Burnout Inventory (MBI) - Emotional Exhaustion Score
Participants will also complete pre and post-intervention MBI surveys to assess changes in burnout symptoms. This survey is composed of 22 items. Each item is scored from 0-6. There are three questions domains: emotional exhaustion (9 items), depersonalization (5 items), and decreased person accomplishment (8 items). The items fall into one of these three categories and there are three domain scores. Higher values in each domain indicate increased burnout in that respective category.
Scores for each item in the Emotional Exhaustion subscale are summed to obtain an overall score. Overall scores for the Emotional Exhaustion subscale can range between 0-54.
Measured: Once before the study intervention and once immediately after intervention at 4 weeks.
Qualitative Interviews
We will administer interviews to assess participant satisfaction with the intervention and control program. They will be administered to each group at the end of the intervention.
Measured: Once immediately after the study intervention at 4 weeks
Change From Baseline in Post-traumatic Diagnostic Scale (PDS-5) - Intrusion Score
Participants will complete pre/post-intervention PDS-5 surveys to assess post traumatic symptoms. This survey includes a pre-screen and 24 items. Each item is placed into the respective PTSD symptom category (as defined by the Diagnostic Statistical Manual-5) and scored. Higher scores in each symptom domain indicate increased chance of PTSD diagnosis. The domains are: intrusion (5 items), avoidance (2 items), changes in mood/cognition (7 items), and arousal/ hyperactivity (6 items). 2 items address "distress and interference" and 2 items address "symptom onset and duration.
Scores for each question range from 0 to 3. The 5 items that contribute to the Intrusion score are summed to yield a possible range of PDS Intrusion scores of 0-15, with higher scores indicating greater intrusion.
Measured: Once before the study intervention and once immediately after the intervention at 4 weeks
Change From Baseline in HADS Anxiety Score
Participants will also complete pre and post-intervention HADS surveys to assess changes in anxiety and depression symptoms. This survey has 14 items that fall into either the anxiety domain (7 items) or the depression domain (7 items). Items are scored 0-3 and scores, with higher scores indicating worse outcomes, and 11+ in each domain indicating abnormal cases.
Scores for the 7 items in the anxiety domain are summed to yield a possible range of 0-21, with higher scores indicating more anxiety.
Measured: Once before the study intervention and once immediately after the intervention at 4 weeks
Changes From Baseline in the MBI-Depersonalization Score
The Maslach Burnout Inventory (MBI) Depersonalization subscale is a 5-item self-report questionnaire that measures impersonal responses toward recipients of the respondent's efforts (e.g. patients). Scores can range between 0-30 with higher scores indicating greater depersonalization.
Measured: Once before the study intervention and once immediately after the intervention at 4 weeks
Change From Baseline in MBI- Personal Accomplishment Score
The Maslach Burnout Inventory (MBI) Personal Accomplishment subscale is a 8-item self-report questionnaire that measures feelings of personal accomplishment and success related to work. Scores can range between 0-48 with higher scores indicating greater sense of accomplishment.
Measured: Once before the study intervention and once immediately after the 4 session intervention
Change From Baseline in PDS-5 Avoidance Score
Participants will also complete pre/post-intervention PDS-5 surveys to assess post traumatic symptoms. This survey includes a pre-screen and 24 items. Each item is placed into the respective PTSD symptom category (as defined by the Diagnostic Statistical Manual-5) and scored. Higher scores in each symptom domain indicate increased chance of PTSD diagnosis. The domains are: intrusion (5 items), avoidance (2 items), changes in mood/cognition (7 items), and arousal/ hyperactivity (6 items). 2 items address "distress and interference" and 2 items address "symptom onset and duration.
Scores for each question range from 0 to 3. The 2 items that contribute to the Avoidance score are summed to yield a possible range of PDS Avoidance scores of 0-6, with higher scores indicating greater avoidance.
Measured: Once before the study intervention and once immediately after the intervention at 4 weeks
Change From Baseline in PDS-5 Arousal Scores
Participants will also complete pre/post-intervention PDS-5 surveys to assess post traumatic symptoms. This survey includes a pre-screen and 24 items. Each item is placed into the respective PTSD symptom category (as defined by the Diagnostic Statistical Manual-5) and scored. Higher scores in each symptom domain indicate increased chance of PTSD diagnosis. The domains are: intrusion (5 items), avoidance (2 items), changes in mood/cognition (7 items), and arousal/ hyperactivity (6 items). 2 items address "distress and interference" and 2 items address "symptom onset and duration.
Scores for each question range from 0 to 3. The 6 items that contribute to the Arousal score are summed to yield a possible range of PDS Arousal scores of 0-18, with higher scores indicating greater arousal.
Measured: Once before the study intervention and once immediately after the intervention at 4 weeks
Change From Baseline in HADS-Depression Score
Participants will also complete pre and post-intervention HADS surveys to assess changes in depression symptoms. This survey has 14 items that fall into either the anxiety domain (7 items) or the depression domain (7 items). Items are scored 0-3 and scores, with higher scores indicating worse outcomes, and 11+ in each domain indicating abnormal cases.
Scores for the 7 items in the depression domain are summed to yield a possible range of 0-21, with higher scores indicating more depression.
Measured: Once before the study intervention and once immediately after the intervention at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start15 Sep 2016
- Primary completion15 Aug 2018
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Burn-Out SyndromeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meredith Mealer, PhD, Principal investigator, University of Colorado, DenverMarc Moss, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132220
- Sponsor's protocol ID
- 17-0279
- Status last verified
- Nov 2019
- First submitted
- 21 Apr 2017
- Last updated
- 9 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan to share IPD is through a limited summary of the data. The information will be de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness Based Cognitive Therapy (MBCT) Resiliency Program for Critical Care Nurses
- ClinicalTrials.gov ID
- NCT03132220
- Acronym / sponsor ID
- 17-0279
- Conditions
- Burn-Out Syndrome, Work-Related Stress Disorder
- Keywords
- critical care nurses, mindfulness-based cognitive therapy, Burn-out Syndrome, Post-traumatic Stress Disorder, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Posted 9 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Developed over 10 years ago, Mindfulness Based Cognitive Therapy (MBCT) synergistically combines mindfulness training and cognitive behavioral therapy and can increase resiliency. In this study, the investigators proposed two aims: Aim #1: To adapt and optimize a MBCT resiliency program specifically for ICU nurses. For this aim, the investigators will engage multiple stakeholder groups to assist the protocol adaptation. Aim # 2: To conduct a pilot clinical trial to determine acceptability of the MBCT resiliency program and the control intervention. In this aim, the investigators will also identify the most feasible randomization level to minimize contamination between the control and intervention groups. Collectively, this proposal will pave the way for a properly designed large multi-center trial of a MBCT resiliency program (MBCT-ICU) to determine its ability to decrease BOS symptoms; and allow nurses to more effectively care for patients in the challenging ICU environment.
Detailed description
The Intensive Care Unit (ICU) is a stressful environment for all critical care healthcare providers. In the United States, there are more than 500,000 critical care (ICU) nurses that treat the most seriously ill patients. These ICU nurses have especially challenging and sometimes overwhelming jobs due to high patient mortality and morbidity, and frequent encounters with ethical dilemmas. The repetitive exposure to these extreme stressors and the inability to adjust to their difficult work environment may cause significant psychological stress. The investigator's multidisciplinary research team was one of the first to identify that ICU nurses have significantly high rates of psychological distress including: symptoms of anxiety and depression, posttraumatic stress disorder (PTSD) and burnout syndrome (BOS).
Work-induced distress initiates a negative cycle that contributes to the unacceptably high ICU nursing turnover rate. Nationally, nursing turnover rates range between 17-20% per year. In the ICU, the growing nursing shortage is particularly concerning. Presently, there are no interventions to reduce BOS in ICU nurses. Many stresses on ICU nurses are inherent to the critical care environment such as performing cardiopulmonary resuscitation and the death of a patient. Therefore, the investigators multidisciplinary research group has focused on enhancing the ability of ICU nurses to adapt to their work environment.
Resiliency enables one to thrive in the face of adversity. Humans respond to stress and trauma in a variety of ways. Some people are resilient; defined as the ability to succeed, to live, and to develop in a positive way despite the stress or adversity that would normally involve the real possibility of a negative outcome. In practice, resilient individuals believe that what they do can have a positive impact on a situation, that some components of the 'system' can be controlled or influenced by one's own actions, that persistent effort is worthwhile, and that setbacks or potentially threatening events are inevitable and surmountable. A variety of qualities are associated with resiliency including the ability to engage the support of others, the belief that stress can be strengthening, and overall optimism. Though some individuals are inherently resilient; resiliency can be learned. Developing resiliency may be one strategy to prevent and treat symptoms of BOS. The investigators have demonstrated that resilient ICU nurses were less likely to have symptoms of anxiety, depression, PTSD, and BOS. The investigators also identified methods used by ICU nurses to promote resiliency and emotional wellness. The investigators ICU nursing pilot program also increased resiliency and decreased symptoms of BOS.
From the investigators prior studies, mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) are two modalities currently used by resilient ICU nurses. In the investigators most recent national survey, ICU nurses were eager to learn MBSR and CBT techniques to help reduce symptoms of BOS. Mindfulness Based Cognitive Therapy (MBCT) combines the best of MBSR and CBT, and may build resiliency and reduce BOS symptoms. MBCT was developed by integrating the framework and practices of MBSR and CBT. Classically incorporated into an 8 week course, MBCT uses mindfulness skills to help individuals become aware of negative thoughts and feelings that are activated by stress. MBCT also incorporates CBT techniques to develop a different relationship to those thoughts and feelings, and interrupt the negative thought patterns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Book Club Active Control | Active comparator | Behavioral: Book Club Active Control InterventionThe subject will participate in 16 in-person hours that are broken into sessions for the book club active control intervention. This club will be facilitated by 1-2 instructors. The club will be described as a "fun activity to do outside of work to help reduce work-related stress." The club will be structured similarly to the intervention with respect to time, and homework expectations. Nurses will be prohibited from talking about work stress. |
| MBCT Intervention | Experimental | Behavioral: Mindfulness-Based Cognitive TherapyThe subject will participate in 16 in-person hours that are broken into sessions for the Mindfulness-Based Cognitive Therapy intervention. The intervention will be facilitated by 1-2 instructors who are trained in clinical psychology/ social work and are also trained in MBCT. This intervention will include mindfulness activities, didactic learning, homework assignments and group dialogue. This adapted MBCT intervention will follow the empirically-based MBCT intervention for depression structure with fidelity. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults ages 18 years or older
- Employed as a critical care nurse and work at least 20 hours per week as an ICU
- Baseline score of < 82 on the Connor-Davidson Resilience Scale (CD-RISC)
- Positive symptoms of at least one BOS dimension using the Maslach Burnout Inventory (MBI):
Key exclusion criteria (6 listed)
- A self-reported diagnosis of:
- Unwillingness to participate in the entire study protocol
- Employment on a time limited contract (i.e. a traveling nurse)
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 |
|---|---|---|
| Mindfulness-Based Cognitive TherapyMindfulness-Based Cognitive therapy is a 16 in-person hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores. | Behavioural | MBCT Intervention |
| Book Club Active Control InterventionParticipants randomized to the book club active control intervention will meet for 16 in-person hours that are broken into sessions. Books will be assigned to read during homework time and discussions regarding the books will occur during the sessions. The time involved will be similar to the MBCT intervention. | Behavioural | Book Club Active Control |
Primary outcome
Change From Baseline in Connor Davidson Resiliency Scale (CD-RISC) Scores
Time frame: Once before the study intervention; one time immediately following the study intervention at 4 weeks.
The primary outcome is the pre-post changes in the CD-RISC scores in intervention and control subjects. The CD-RISC scale assesses resiliency in individuals. There are 25 items in the survey, each item is scored from 0-4, and the total ranges from 0-100. Higher scores indicate increased resiliency. Any individuals who score above 81 points on this survey will not qualify for this study as they are too inherently resilient. The study intervention will typically last 4 sessions, one session per week at a total of 4 weeks.
10 secondary outcomes
Changes in Acceptability of the Sessions, on the Client Satisfaction Questionnaire (CSQ-8)
Time frame: Weekly during the 4 session/week intervention
Change From Baseline in Maslach Burnout Inventory (MBI) - Emotional Exhaustion Score
Time frame: Once before the study intervention and once immediately after intervention at 4 weeks.
Qualitative Interviews
Time frame: Once immediately after the study intervention at 4 weeks
Change From Baseline in Post-traumatic Diagnostic Scale (PDS-5) - Intrusion Score
Time frame: Once before the study intervention and once immediately after the intervention at 4 weeks
Change From Baseline in HADS Anxiety Score
Time frame: Once before the study intervention and once immediately after the intervention at 4 weeks
Changes From Baseline in the MBI-Depersonalization Score
Time frame: Once before the study intervention and once immediately after the intervention at 4 weeks
Change From Baseline in MBI- Personal Accomplishment Score
Time frame: Once before the study intervention and once immediately after the 4 session intervention
Change From Baseline in PDS-5 Avoidance Score
Time frame: Once before the study intervention and once immediately after the intervention at 4 weeks
Change From Baseline in PDS-5 Arousal Scores
Time frame: Once before the study intervention and once immediately after the intervention at 4 weeks
Change From Baseline in HADS-Depression Score
Time frame: Once before the study intervention and once immediately after the intervention at 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The plan to share IPD is through a limited summary of the data. The information will be de-identified.
Related trials for Burn-Out Syndrome
Recruiting
Creative Arts Program to Reduce Burnout in Healthcare Professionals
Burn-Out Syndrome, Post-Traumatic Stress Disorder
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.
Meredith Mealer, PhD principal investigator
University of Colorado, Denver
Marc Moss, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy in people with Burn-Out Syndrome and Work-Related Stress Disorder, run by University of Colorado, Denver 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 7 inclusion and 6 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 Dec 2019. 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?
Yes. Results are posted in the registry (first posted 9 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Connor Davidson Resiliency Scale (CD-RISC) Scores (time frame: Once before the study intervention; one time immediately following the study intervention at 4 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 9 Dec 2019; AzTrials last refreshed its copy on 28 Oct 2026.