Work-Related Stress Disorder Clinical Trial
Official title:
A Mindfulness Based Cognitive Therapy (MBCT) Resiliency Program for Critical Care Nurses
Verified date | November 2019 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04945837 -
Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area
|
N/A | |
Recruiting |
NCT06383715 -
Congitive Behavioral Therapy Workshop for Content Moderators
|
N/A | |
Active, not recruiting |
NCT03634410 -
SeniorWorkingLife (Danish Title: SeniorArbejdsLiv)
|
||
Completed |
NCT03908554 -
The Effects of "Workplace Health Promotion Program" on Pain, Fatigue, Stress in Nurses
|
N/A |