NCT03132220|CompletedResultsDMC
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Sponsor study identifier
interventional
131
1 country
1
Study Start
September 15, 2016
Actual (reported)Primary Completion
August 15, 2018
Actual (reported)Study Completion
September 15, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 15, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 15, 2016
Actual (reported)April 21, 2017
Actual (reported)April 27, 2017
Actual (reported)August 15, 2018
Actual (reported)September 15, 2019
Actual (reported)December 9, 2019
Actual (reported)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.
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
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.
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.
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.
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.
University of Colorado Hospital
Denver, Colorado, 80045, United States
Meredith Mealer, PhD
University of Colorado, Denver
Marc Moss, MD
University of Colorado, Denver
131 participants (actual enrollment reported by the registry).
First Submitted
April 21, 2017
First Posted
April 27, 2017
Study Start
September 15, 2016
Actual (reported)Mindfulness-Based Cognitive Therapy for Fatigue in Inflammatory Bowel Disease Patients: a Randomized Controlled Trial
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 15, 2018
Actual (reported)Study Completion
September 15, 2019
Actual (reported)Last Updated
December 9, 2019
Results First Posted
December 9, 2019
Record last verified: 2019-11
The plan to share IPD is through a limited summary of the data. The information will be de-identified.
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Source: ClinicalTrials.gov.
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