A Mindfulness Based Cognitive Therapy (MBCT) Resiliency Program for Critical Care Nurses

Work-Related Stress Disorder Clinical Trial

Official title:

A Mindfulness Based Cognitive Therapy (MBCT) Resiliency Program for Critical Care Nurses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03132220
• Other study ID #: 17-0279
• Status: Completed
• Phase: N/A
• Start date: September 15, 2016
• Est. completion date: September 15, 2019

Study information

• Verified date: November 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: September 15, 2019
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

1. Adults ages 18 years or older

2. Employed as a critical care nurse and work at least 20 hours per week as an ICU

3. Baseline score of < 82 on the Connor-Davidson Resilience Scale (CD-RISC)

4. 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.

Exclusion Criteria:

1. A self-reported diagnosis of:

• bipolar or psychotic disorder,

• active substance dependence, or

• immediate risk of self-harm or need for hospitalization

2. Unwillingness to participate in the entire study protocol

3. Employment on a time limited contract (i.e. a traveling nurse)

Related Conditions & MeSH terms

• Burn-Out Syndrome
• Burnout, Psychological
• Occupational Stress
• Stress Disorders, Traumatic
• Work-Related Stress Disorder

Intervention

Behavioral:
• Mindfulness-Based Cognitive Therapy
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 Intervention
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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Once before the study intervention; one time immediately following the study intervention at 4 weeks.
Secondary	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.	Weekly during the 4 session/week intervention
Secondary	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.	Once before the study intervention and once immediately after intervention at 4 weeks.
Secondary	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.	Once immediately after the study intervention at 4 weeks
Secondary	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.	Once before the study intervention and once immediately after the intervention at 4 weeks
Secondary	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.	Once before the study intervention and once immediately after the intervention at 4 weeks
Secondary	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.	Once before the study intervention and once immediately after the intervention at 4 weeks
Secondary	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.	Once before the study intervention and once immediately after the 4 session intervention
Secondary	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.	Once before the study intervention and once immediately after the intervention at 4 weeks
Secondary	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.	Once before the study intervention and once immediately after the intervention at 4 weeks
Secondary	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.	Once before the study intervention and once immediately after the intervention at 4 weeks