Clinical trial NCT03132220: A Mindfulness Based Cognitive Therapy (MBCT) Resiliency Program for Critical Care Nurses
Official title: A Mindfulness Based Cognitive Therapy (MBCT) Resiliency Program for Critical Care Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in Connor Davidson Resiliency Scale (CD-RISC) Scores
timeFrame: Once before the study intervention; one time immediately following the study intervention at 4 weeks.
Secondary outcomes:
measure: Changes in Acceptability of the Sessions, on the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Weekly during the 4 session/week intervention
measure: Change From Baseline in Maslach Burnout Inventory (MBI) - Emotional Exhaustion Score
timeFrame: Once before the study intervention and once immediately after intervention at 4 weeks.
measure: Qualitative Interviews
timeFrame: Once immediately after the study intervention at 4 weeks
measure: Change From Baseline in Post-traumatic Diagnostic Scale (PDS-5) - Intrusion Score
timeFrame: Once before the study intervention and once immediately after the intervention at 4 weeks
measure: Change From Baseline in HADS Anxiety Score
timeFrame: Once before the study intervention and once immediately after the intervention at 4 weeks
measure: Changes From Baseline in the MBI-Depersonalization Score
timeFrame: Once before the study intervention and once immediately after the intervention at 4 weeks
measure: Change From Baseline in MBI- Personal Accomplishment Score
timeFrame: Once before the study intervention and once immediately after the 4 session intervention
measure: Change From Baseline in PDS-5 Avoidance Score
timeFrame: Once before the study intervention and once immediately after the intervention at 4 weeks
measure: Change From Baseline in PDS-5 Arousal Scores
timeFrame: Once before the study intervention and once immediately after the intervention at 4 weeks
measure: Change From Baseline in HADS-Depression Score
timeFrame: Once before the study intervention and once immediately after the intervention at 4 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Meredith Mealer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Marc Moss, MD
role: PRINCIPAL_INVESTIGATOR
References: