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

NCT ID: NCT03132220

Last Updated: 2019-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-15
• Study Completion Date: 2019-09-15

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.

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Book Club Active Control

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.

Group Type: ACTIVE_COMPARATOR

Book Club Active Control Intervention

Intervention Type: BEHAVIORAL

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.

MBCT Intervention

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.

Group Type: EXPERIMENTAL

Mindfulness-Based Cognitive Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meredith Mealer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Marc Moss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Denver, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-0279

Identifier Type: -

Identifier Source: org_study_id