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

NCT03132220 | Completed Results DMC

• 1 other identifier: 17-0279
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Changes in Acceptability of the Sessions, on the Client Satisfaction Questionnaire (CSQ-8)

  Weekly during the 4 session/week intervention

• Change From Baseline in Maslach Burnout Inventory (MBI) - Emotional Exhaustion Score

  Once before the study intervention and once immediately after intervention at 4 weeks.

• Qualitative Interviews

  Once immediately after the study intervention at 4 weeks

• Change From Baseline in Post-traumatic Diagnostic Scale (PDS-5) - Intrusion Score

  Once before the study intervention and once immediately after the intervention at 4 weeks

• Change From Baseline in HADS Anxiety Score

  Once before the study intervention and once immediately after the intervention at 4 weeks

Study Arms (2)

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.

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.

Behavioral: Mindfulness-Based Cognitive Therapy

Interventions

Mindfulness-Based Cognitive Therapy 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.

MBCT Intervention

Book Club Active Control Intervention 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.

Book Club Active Control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Burnout, Psychological; Stress Disorders, Post-Traumatic

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Meredith Mealer
• Organization: University of Colorado School of Medicine

Meredith.Mealer@cuanschutz.edu

303-724-6857

Study Officials

• Meredith Mealer, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Marc Moss, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 27, 2017
• Study Start: September 15, 2016
• Primary Completion: August 15, 2018
• Study Completion: September 15, 2019
• Last Updated: December 9, 2019
• Results First Posted: December 9, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)