Trial Outcomes & Findings for A Mindfulness Based Cognitive Therapy (MBCT) Resiliency Program for Critical Care Nurses (NCT NCT03132220)

Last Updated: 2019-12-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

131 participants

Primary outcome timeframe

Once before the study intervention; one time immediately following the study intervention at 4 weeks.

Results posted on

2019-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	MBCT Intervention The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of post-traumatic stress disorder (PTSD) and burnout syndrome (BOS) and increase resiliency scores.	Book Club Active Control The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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.
Overall Study STARTED	65	66
Overall Study Began Study Sessions	48	58
Overall Study COMPLETED	47	54
Overall Study NOT COMPLETED	18	12

Reasons for withdrawal

Reasons for withdrawal
Measure	MBCT Intervention The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of post-traumatic stress disorder (PTSD) and burnout syndrome (BOS) and increase resiliency scores.	Book Club Active Control The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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.
Overall Study Lost to Follow-up	17	8
Overall Study Withdrawal by Subject	1	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Book Club Active Control n=58 Participants The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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 n=48 Participants The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.	Total n=106 Participants Total of all reporting groups
Age, Continuous	32.4 years STANDARD_DEVIATION 7.35 • n=5 Participants	33.0 years STANDARD_DEVIATION 6.50 • n=7 Participants	32.6 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	45 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized % Caucasian	55 Participants n=5 Participants	44 Participants n=7 Participants	99 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic, % yes	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Years practicing as nurse	6.8 years STANDARD_DEVIATION .91 • n=5 Participants	6.5 years STANDARD_DEVIATION .95 • n=7 Participants	6.6 years STANDARD_DEVIATION 6.7 • n=5 Participants
Years practicing in Intensive Care Unit (ICU)	5.3 years STANDARD_DEVIATION .78 • n=5 Participants	5.2 years STANDARD_DEVIATION 5.9 • n=7 Participants	5.3 years STANDARD_DEVIATION 5.8 • n=5 Participants
Medication for anxiety, yes	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Medication for depression, yes	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Exercise, yes	52 Participants n=5 Participants	45 Participants n=7 Participants	97 Participants n=5 Participants
Practice mindfulness, yes	14 Participants n=5 Participants	4 Participants n=7 Participants	18 Participants n=5 Participants
Current therapy/counseling, yes	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Hospital Anxiety and Depression Scale (HADS)-Anxiety, % positive	45 Participants n=5 Participants	29 Participants n=7 Participants	74 Participants n=5 Participants
Hospital Anxiety and Depression Scale (HADS)-Depression, % positive	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Maslach Burnout Inventory (MBI)-Emotion Exhaustion, % positive	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Maslach Burnout Inventory (MBI)-Depersonalization, % positive	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants
Maslach Burnout Inventory (MBI)-Reduce Personal Accomplishment, % positive	41 Participants n=5 Participants	28 Participants n=7 Participants	69 Participants n=5 Participants

PRIMARY outcome

Timeframe: Once before the study intervention; one time immediately following the study intervention at 4 weeks.

Outcome measures

Outcome measures
Measure	Book Club Active Control n=52 Participants The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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 n=45 Participants The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.
Change From Baseline in Connor Davidson Resiliency Scale (CD-RISC) Scores Pre-intervention	66.9 score on a scale Standard Deviation 9.1	67.6 score on a scale Standard Deviation 7.9
Change From Baseline in Connor Davidson Resiliency Scale (CD-RISC) Scores Post-Intervention	73.6 score on a scale Standard Deviation 10.3	72.3 score on a scale Standard Deviation 9.4

SECONDARY outcome

Timeframe: Weekly during the 4 session/week intervention

Population: Some pts. did not complete the CSQ-8 survey each week, thus variations in the no. of participants analyzed each week for the MBCT cohorts exist.

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.

Outcome measures

Outcome measures
Measure	Book Club Active Control n=49 Participants The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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 n=46 Participants The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.
Changes in Acceptability of the Sessions, on the Client Satisfaction Questionnaire (CSQ-8) Week 1	25.5 score on a scale Standard Deviation 3.1	26.2 score on a scale Standard Deviation 3.2
Changes in Acceptability of the Sessions, on the Client Satisfaction Questionnaire (CSQ-8) Week 2	25.4 score on a scale Standard Deviation 3.4	27.0 score on a scale Standard Deviation 3.0
Changes in Acceptability of the Sessions, on the Client Satisfaction Questionnaire (CSQ-8) Week 3	24.9 score on a scale Standard Deviation 4.4	28.2 score on a scale Standard Deviation 3.4
Changes in Acceptability of the Sessions, on the Client Satisfaction Questionnaire (CSQ-8) Week 4	25.5 score on a scale Standard Deviation 4.8	28.2 score on a scale Standard Deviation 3.8

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Book Club Active Control n=52 Participants The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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 n=45 Participants The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.
Change From Baseline in Maslach Burnout Inventory (MBI) - Emotional Exhaustion Score Pre-intervention	26.4 score on a scale Standard Deviation 9.8	29.2 score on a scale Standard Deviation 9.1
Change From Baseline in Maslach Burnout Inventory (MBI) - Emotional Exhaustion Score Post-Intervention	24.9 score on a scale Standard Deviation 10.2	29.0 score on a scale Standard Deviation 9.1

SECONDARY outcome

Timeframe: Once immediately after the study intervention at 4 weeks

Population: Data were not collected

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Book Club Active Control n=52 Participants The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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 n=45 Participants The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.
Change From Baseline in Post-traumatic Diagnostic Scale (PDS-5) - Intrusion Score Pre-intervention	3.9 score on a scale Standard Deviation 3.1	4.3 score on a scale Standard Deviation 2.8
Change From Baseline in Post-traumatic Diagnostic Scale (PDS-5) - Intrusion Score Post-Intervention	3.7 score on a scale Standard Deviation 3.2	4.5 score on a scale Standard Deviation 3.2

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Book Club Active Control n=52 Participants The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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 n=45 Participants The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.
Change From Baseline in HADS Anxiety Score Pre-intervention	9.6 score on a scale Standard Deviation 3.3	9.0 score on a scale Standard Deviation 3.4
Change From Baseline in HADS Anxiety Score Post-Intervention	8.0 score on a scale Standard Deviation 3.2	8.6 score on a scale Standard Deviation 3.2

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Book Club Active Control n=52 Participants The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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 n=45 Participants The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.
Changes From Baseline in the MBI-Depersonalization Score Post-Intervention	10.5 score on a scale Standard Deviation 6.5	12.7 score on a scale Standard Deviation 5.9
Changes From Baseline in the MBI-Depersonalization Score Pre-intervention	10.8 score on a scale Standard Deviation 6.0	11.8 score on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: Once before the study intervention and once immediately after the 4 session intervention

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.

Outcome measures

Outcome measures
Measure	Book Club Active Control n=52 Participants The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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 n=45 Participants The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.
Change From Baseline in MBI- Personal Accomplishment Score Pre-intervention	29.9 score on a scale Standard Deviation 6.3	30.8 score on a scale Standard Deviation 5.7
Change From Baseline in MBI- Personal Accomplishment Score Post-Intervention	34.1 score on a scale Standard Deviation 7.1	34.0 score on a scale Standard Deviation 6.5

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Book Club Active Control n=52 Participants The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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 n=45 Participants The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.
Change From Baseline in PDS-5 Avoidance Score Pre-intervention	2.0 score on a scale Standard Deviation 1.6	1.9 score on a scale Standard Deviation 1.5
Change From Baseline in PDS-5 Avoidance Score Post-Intervention	1.5 score on a scale Standard Deviation 1.4	2.0 score on a scale Standard Deviation 1.7

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Book Club Active Control n=52 Participants The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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 n=45 Participants The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.
Change From Baseline in PDS-5 Arousal Scores Pre-intervention	5.1 score on a scale Standard Deviation 3.7	4.6 score on a scale Standard Deviation 3.5
Change From Baseline in PDS-5 Arousal Scores Post-Intervention	4.3 score on a scale Standard Deviation 4.3	5.0 score on a scale Standard Deviation 3.7

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Book Club Active Control n=52 Participants The subject will participate in 16 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. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 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 n=45 Participants The subject will participate in 16 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: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.
Change From Baseline in HADS-Depression Score Pre-intervention	5.7 score on a scale Standard Deviation 4.0	5.8 score on a scale Standard Deviation 3.9
Change From Baseline in HADS-Depression Score Post-Intervention	4.5 score on a scale Standard Deviation 4.2	4.7 score on a scale Standard Deviation 4.1

Adverse Events

Book Club Active Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MBCT Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Meredith Mealer

University of Colorado School of Medicine

Phone: 303-724-6857

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place