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Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers

Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03784846
Enrollment
109
Registered
2018-12-24
Start date
2019-10-01
Completion date
2022-06-30
Last updated
2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggression, Stress, Psychological

Brief summary

Law enforcement officers (LEOs) are exposed to significant stressors, elevating their risk for aggression and excessive use of force, as well as mental health consequences, including post-traumatic stress disorder, burnout, alcohol misuse, depression, and suicide. The proposed study will identify, optimize and refine best clinical and research practices across two sites to ensure success in a future multisite efficacy trial assessing preventative effects of Mindfulness-Based Resilience Training on physiological, behavioral, and psychological outcomes.

Detailed description

Law enforcement officers (LEOs) are exposed to significant stressors, elevating their risk for aggression and excessive use of force. Such dysfunctional stress reactivity can lead to devastating consequences for their community, including unjustified shootings, severe beatings, and fatal chokings. It can also lead to serious consequences for the LEOs, including elevated incidence of post-traumatic stress disorder, burnout, alcohol misuse, depression, and suicide. A recent meta-analysis of LEO stress reduction programs found little evidence to demonstrate that such approaches are effective, highlighting the urgent need for preventive interventions targeting the stress inherent to policing. Mindfulness training is a promising approach with high-stress populations that has been shown effective in reducing stress and increasing resilience. In a recent pilot feasibility study (R21AT008854), the study team established initial feasibility, acceptability, and adherence to procedures in a single-site RCT assessing Mindfulness-Based Resilience Training (MBRT), a preventive intervention designed to improve LEO mental health and resilience, and reduce aggression and excessive use of force. The R21 data suggest physiological mechanisms and potential clinical benefit in a sample of LEOs. Relative to waitlist control, MBRT participants showed improvements in stress reactivity, aggression, burnout, occupational stress, sleep disturbance, and psychological flexibility. Implemented at two sites, the proposed study is designed to establish optimal protocols and procedures for a future full-scale, multi-site trial assessing effects of MBRT versus an attention control (Stress Management Education) and a no-intervention control, on physiological, behavioral, and psychological outcomes. To prepare for this future clinical trial, this study will: a) enhance efficiency of recruitment, engagement and retention; b) optimize lab, assessment, and data management procedures; c) optimize intervention training and ensure fidelity to intervention protocols; and d) assess participant experience and optimize outcome measures across sites. The long-term objective of this line of research is to develop an intervention that will reduce violence and increase resilience among LEOs, as well as yield significant benefits for communities and residents they serve.

Interventions

MBRT is an 8-week program combining training in standardized mindfulness practices targeting factors that facilitate resilience, CBT, and psychoeducation. It contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions.

SME was designed as an active control condition for other Mindfulness-Based Intervention trials. SME uses a group-based didactic approach with modules on physiological and dietary effects of stress, time management, sleep physiology and insomnia, nutrition, exercise, stress hardiness, and factors mitigating impacts of stress.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Pacific University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Individually-Randomized Group Treatment

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* be 21-65 years old (age limitations for both police departments), * demonstrate English fluency, * be a sworn, full-time, active status law enforcement officer, * agree to random assignment to condition, and * be willing to complete assessments at multiple time points and attend intervention groups

Exclusion criteria

* previous participation in MBSR, MBRT or a similar mindfulness course, * score in the severe range on brief screening measures of depression, suicidal ideation, alcohol use, or PTSD, or * unable or unwilling to give written informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Change in Aggressionbaseline, post-intervention (week 8), 3-month followup, 6-month followupBuss-Perry Aggression Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater aggression.

Secondary

MeasureTime frameDescription
Change in Interleukin-6baseline, post-intervention (8 weeks), 3 month followupBlood spot analysis of interleukin-6.
Change in Interleukin-10baseline, post-intervention (8 weeks), 3 month followupBlood spot analysis of interleukin-10.
Change in Tumor Necrosis Factor-alphabaseline, post-intervention (8 weeks), 3 month followupBlood spot analysis of tumor necrosis factor-alpha.
Change in Psychological Resiliencebaseline, post-intervention (8 weeks), 3 month followup, 6 month followupBrief Resilience Scale. Scores range from 1-5, with higher scores indicating greater resilience.
Change in Alcohol Usebaseline, post-intervention (8 weeks), 3 month followup, 6 month followupPatient Reported Outcome Measurement System (PROMIS) Alcohol Use. Scores range from 39-77, with higher scores indicating greater alcohol use.
Change in Alcohol Use Negative Consequencesbaseline, post-intervention (8 weeks), 3 month followup, 6 month followupPatient Reported Outcome Measurement System (PROMIS) Alcohol Use Negative Consequences.Scores range from 39-77, with higher scores indicating greater alcohol use negative consequences.
Change in Depressionbaseline, post-intervention (8 weeks), 3 month followup, 6 month followupPatient Reported Outcome Measurement System (PROMIS) Depression. Scores range from 38-80, with higher scores indicating more depression.
Change in Suicidal Thinkingbaseline, post-intervention (8 weeks), 3 month followup, 6 month followupConcise Heath Risk Tracking Scale-Self-Report. Scores range from 7-35, with higher scores indicating greater suicidal ideation.
Change in Trauma Symptomsbaseline, post-intervention (8 weeks), 3 month followup, 6 month followupPTSD Checklist for DSM-5. Scores ranges from 0-80, with higher scores indicating greater PTSD symptoms.
Change in Burnoutbaseline, post-intervention (8 weeks), 3 month followup, 6 month followupOldenburg Burnout Inventory. Scores range from 1-4, with higher scores indicating greater burnout.
Change in C-reactive Proteinbaseline, post-intervention (8 weeks), 3 month followupBlood spot analysis of high-sensitivity C-reactive protein.
Change in Perceived Stressbaseline, post-intervention (8 weeks), 3 month followup, 6 month followupPerceived Stress Scale-10. Scores range from 0-40, with higher scores indicating greater perceived stress.
Change in Sleep Disturbancebaseline, post-intervention (8 weeks), 3 month followup, 6 month followupPatient Reported Outcome Measurement System (PROMIS) Sleep Disturbance. Scores range from 32-76, with higher scores indicating greater sleep disturbance.
Change in Self-Compassionbaseline, post-intervention (8 weeks), 3 month followup, 6 month followupSelf-Compassion Scale-Short Form. Scores range from 1-5, with higher scores indicating greater self-compassion.
Change in Mindfulnessbaseline, post-intervention (8 weeks), 3 month followup, 6 month followupFive Facet Mindfulness Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater mindfulness.
Change in Interoceptive Awarenessbaseline, post-intervention (8 weeks), 3 month followup, 6 month followupMultidimensional Assessment of Interoceptive Awareness-II. Scores range from 1-6, with higher scores indicating greater interoceptive awareness.
Treatment Acceptabilitypost-intervention (8 weeks)Postcourse satisfaction survey. Scores range from 4-16, with higher scores indicating greater treatment acceptability. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.
Treatment Compliancepost-intervention (8 weeks)Objective assessment of duration of homework practice. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.
Treatment Expectancy and CredibilitybaselineExpectancy/Credibility Questionnaire. Scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Scores range from 7-21, with higher scores indicating greater expectancy and credibility.
Global Impression of Changepost-intervention (8 weeks)Clinical Global Impressions Scale. Measure of perceived change in functioning as a result of the intervention. Scores range from 3-21, with higher scores indicating a greater impression of change. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.
Change in Sustained Attentionbaseline, post-intervention (8 weeks), 3 month followup, 6 month followupSustained Attention to Response Task. A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amongst a background of frequent non-targets. Increased errors indicates less sustained attention.

Countries

United States

Participant flow

Pre-assignment details

All enrolled participants were assigned to a study arm.

Participants by arm

ArmCount
Mindfulness-Based Resilience Training
MBRT is an 8-week program combining training in standardized mindfulness practices targeting factors that facilitate resilience, cognitive behavioral therapy (CBT), and psychoeducation. It contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions. Mindfulness-Based Resilience Training: MBRT is an 8-week program combining training in standardized mindfulness practices targeting factors that facilitate resilience, CBT, and psychoeducation. It contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions.
50
Stress Management Education
SME was designed as an active control condition for other mindfulness-based intervention trials. SME uses a group-based didactic approach with modules on physiological and dietary effects of stress, time management, sleep physiology and insomnia, nutrition, exercise, stress hardiness, and factors mitigating impacts of stress. Stress Management Education: SME was designed as an active control condition for other Mindfulness-Based Intervention trials. SME uses a group-based didactic approach with modules on physiological and dietary effects of stress, time management, sleep physiology and insomnia, nutrition, exercise, stress hardiness, and factors mitigating impacts of stress.
38
No Intervention Control
No contact control condition (other than baseline, post, and follow-up assessments)
21
Total109

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Post-COVID StudyLost to Follow-up351
Post-COVID StudyWithdrawal by Subject120
Pre-COVID StudyDiscontinued by Researchers762
Pre-COVID StudyLost to Follow-up332
Pre-COVID StudyWithdrawal by Subject121

Baseline characteristics

CharacteristicMindfulness-Based Resilience TrainingStress Management EducationNo Intervention ControlTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
50 Participants38 Participants21 Participants109 Participants
Age, Continuous40.22 years
STANDARD_DEVIATION 10.03
39.18 years
STANDARD_DEVIATION 8.06
38.90 years
STANDARD_DEVIATION 10.09
39.61 years
STANDARD_DEVIATION 9.33
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants9 Participants4 Participants29 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
32 Participants29 Participants16 Participants77 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants1 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
4 Participants1 Participants1 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants0 Participants0 Participants3 Participants
Race (NIH/OMB)
White
41 Participants36 Participants19 Participants96 Participants
Region of Enrollment
United States
50 participants38 participants21 participants109 participants
Sex: Female, Male
Female
12 Participants9 Participants5 Participants26 Participants
Sex: Female, Male
Male
38 Participants29 Participants16 Participants83 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 500 / 380 / 21
other
Total, other adverse events
1 / 500 / 380 / 21
serious
Total, serious adverse events
0 / 500 / 380 / 21

Outcome results

Primary

Change in Aggression

Buss-Perry Aggression Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater aggression.

Time frame: baseline, post-intervention (week 8), 3-month followup, 6-month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in AggressionBaseline1.94 score on a scaleStandard Deviation 0.64
Mindfulness-Based Resilience Training (MBRT)Change in Aggressionpost-intervention (week 8)1.72 score on a scaleStandard Deviation 0.48
Mindfulness-Based Resilience Training (MBRT)Change in Aggression3-month followup1.63 score on a scaleStandard Deviation 0.5
Mindfulness-Based Resilience Training (MBRT)Change in Aggression6-month followup1.57 score on a scaleStandard Deviation 0.46
Stress Management Education (SME)Change in Aggression6-month followup1.69 score on a scaleStandard Deviation 0.6
Stress Management Education (SME)Change in AggressionBaseline1.67 score on a scaleStandard Deviation 0.45
Stress Management Education (SME)Change in Aggression3-month followup1.58 score on a scaleStandard Deviation 0.37
Stress Management Education (SME)Change in Aggressionpost-intervention (week 8)1.68 score on a scaleStandard Deviation 0.57
No Intervention ControlChange in Aggression6-month followup1.78 score on a scaleStandard Deviation 0.66
No Intervention ControlChange in Aggressionpost-intervention (week 8)1.98 score on a scaleStandard Deviation 0.82
No Intervention ControlChange in Aggression3-month followup1.84 score on a scaleStandard Deviation 0.76
No Intervention ControlChange in AggressionBaseline1.85 score on a scaleStandard Deviation 0.79
Secondary

Change in Alcohol Use

Patient Reported Outcome Measurement System (PROMIS) Alcohol Use. Scores range from 39-77, with higher scores indicating greater alcohol use.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Alcohol Usebaseline46.62 score on a scaleStandard Deviation 7.48
Mindfulness-Based Resilience Training (MBRT)Change in Alcohol Usepost-intervention (8 weeks)46.95 score on a scaleStandard Deviation 7.6
Mindfulness-Based Resilience Training (MBRT)Change in Alcohol Use3-month followup48.00 score on a scaleStandard Deviation 7.72
Mindfulness-Based Resilience Training (MBRT)Change in Alcohol Use6-month followup47.82 score on a scaleStandard Deviation 6.82
Stress Management Education (SME)Change in Alcohol Use6-month followup46.65 score on a scaleStandard Deviation 7.74
Stress Management Education (SME)Change in Alcohol Usebaseline45.50 score on a scaleStandard Deviation 7.46
Stress Management Education (SME)Change in Alcohol Use3-month followup49.01 score on a scaleStandard Deviation 6.51
Stress Management Education (SME)Change in Alcohol Usepost-intervention (8 weeks)48.54 score on a scaleStandard Deviation 6.58
No Intervention ControlChange in Alcohol Use6-month followup48.98 score on a scaleStandard Deviation 5.94
No Intervention ControlChange in Alcohol Usepost-intervention (8 weeks)45.73 score on a scaleStandard Deviation 6.5
No Intervention ControlChange in Alcohol Use3-month followup45.78 score on a scaleStandard Deviation 6.2
No Intervention ControlChange in Alcohol Usebaseline44.42 score on a scaleStandard Deviation 5.79
Secondary

Change in Alcohol Use Negative Consequences

Patient Reported Outcome Measurement System (PROMIS) Alcohol Use Negative Consequences.Scores range from 39-77, with higher scores indicating greater alcohol use negative consequences.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Alcohol Use Negative Consequencesbaseline40.67 score on a scaleStandard Deviation 5.44
Mindfulness-Based Resilience Training (MBRT)Change in Alcohol Use Negative Consequencespost-intervention (8 weeks)40.98 score on a scaleStandard Deviation 4.99
Mindfulness-Based Resilience Training (MBRT)Change in Alcohol Use Negative Consequences3-month followup40.81 score on a scaleStandard Deviation 5.4
Mindfulness-Based Resilience Training (MBRT)Change in Alcohol Use Negative Consequences6-month followup41.26 score on a scaleStandard Deviation 5.17
Stress Management Education (SME)Change in Alcohol Use Negative Consequences6-month followup40.81 score on a scaleStandard Deviation 5.34
Stress Management Education (SME)Change in Alcohol Use Negative Consequencesbaseline40.35 score on a scaleStandard Deviation 5.21
Stress Management Education (SME)Change in Alcohol Use Negative Consequences3-month followup41.06 score on a scaleStandard Deviation 4.93
Stress Management Education (SME)Change in Alcohol Use Negative Consequencespost-intervention (8 weeks)41.06 score on a scaleStandard Deviation 5.35
No Intervention ControlChange in Alcohol Use Negative Consequences6-month followup40.74 score on a scaleStandard Deviation 5.51
No Intervention ControlChange in Alcohol Use Negative Consequencespost-intervention (8 weeks)41.03 score on a scaleStandard Deviation 4.8
No Intervention ControlChange in Alcohol Use Negative Consequences3-month followup42.53 score on a scaleStandard Deviation 5.47
No Intervention ControlChange in Alcohol Use Negative Consequencesbaseline40.49 score on a scaleStandard Deviation 4.91
Secondary

Change in Burnout

Oldenburg Burnout Inventory. Scores range from 1-4, with higher scores indicating greater burnout.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Burnoutbaseline2.40 score on a scaleStandard Deviation 0.46
Mindfulness-Based Resilience Training (MBRT)Change in Burnout3-month followup2.34 score on a scaleStandard Deviation 0.38
Mindfulness-Based Resilience Training (MBRT)Change in Burnout6-month followup2.32 score on a scaleStandard Deviation 0.42
Mindfulness-Based Resilience Training (MBRT)Change in Burnoutpost-intervention (week 8)2.39 score on a scaleStandard Deviation 0.44
Stress Management Education (SME)Change in Burnoutbaseline2.36 score on a scaleStandard Deviation 0.35
Stress Management Education (SME)Change in Burnoutpost-intervention (week 8)2.36 score on a scaleStandard Deviation 0.29
Stress Management Education (SME)Change in Burnout3-month followup2.33 score on a scaleStandard Deviation 0.3
Stress Management Education (SME)Change in Burnout6-month followup2.42 score on a scaleStandard Deviation 0.35
No Intervention ControlChange in Burnout3-month followup2.36 score on a scaleStandard Deviation 0.24
No Intervention ControlChange in Burnoutbaseline2.38 score on a scaleStandard Deviation 0.36
No Intervention ControlChange in Burnoutpost-intervention (week 8)2.33 score on a scaleStandard Deviation 0.26
No Intervention ControlChange in Burnout6-month followup2.37 score on a scaleStandard Deviation 0.28
Secondary

Change in C-reactive Protein

Blood spot analysis of high-sensitivity C-reactive protein.

Time frame: baseline, post-intervention (8 weeks), 3 month followup

Population: Numbers at post-intervention and 3-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in C-reactive Proteinpost-intervention (week 8).99 units on a scale mg/LStandard Deviation 1.26
Mindfulness-Based Resilience Training (MBRT)Change in C-reactive Proteinbaseline1.22 units on a scale mg/LStandard Deviation 1.42
Mindfulness-Based Resilience Training (MBRT)Change in C-reactive Protein3-month followup.90 units on a scale mg/LStandard Deviation 1.06
Stress Management Education (SME)Change in C-reactive Proteinpost-intervention (week 8).80 units on a scale mg/LStandard Deviation 1.13
Stress Management Education (SME)Change in C-reactive Proteinbaseline.61 units on a scale mg/LStandard Deviation 0.62
Stress Management Education (SME)Change in C-reactive Protein3-month followup.61 units on a scale mg/LStandard Deviation 2.41
No Intervention ControlChange in C-reactive Proteinbaseline2.11 units on a scale mg/LStandard Deviation 2.59
No Intervention ControlChange in C-reactive Protein3-month followup1.66 units on a scale mg/LStandard Deviation 0.58
No Intervention ControlChange in C-reactive Proteinpost-intervention (week 8)1.11 units on a scale mg/LStandard Deviation 0.76
Secondary

Change in Depression

Patient Reported Outcome Measurement System (PROMIS) Depression. Scores range from 38-80, with higher scores indicating more depression.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Depressionbaseline50.15 score on a scaleStandard Deviation 7.99
Mindfulness-Based Resilience Training (MBRT)Change in Depressionpost-intervention (week 8)49.22 score on a scaleStandard Deviation 5.74
Mindfulness-Based Resilience Training (MBRT)Change in Depression3-month followup49.50 score on a scaleStandard Deviation 7.36
Mindfulness-Based Resilience Training (MBRT)Change in Depression6-month followup48.98 score on a scaleStandard Deviation 7.35
Stress Management Education (SME)Change in Depression6-month followup48.14 score on a scaleStandard Deviation 8.07
Stress Management Education (SME)Change in Depressionbaseline48.17 score on a scaleStandard Deviation 6.69
Stress Management Education (SME)Change in Depression3-month followup49.01 score on a scaleStandard Deviation 7.87
Stress Management Education (SME)Change in Depressionpost-intervention (week 8)48.02 score on a scaleStandard Deviation 8.66
No Intervention ControlChange in Depression6-month followup46.73 score on a scaleStandard Deviation 9.49
No Intervention ControlChange in Depressionpost-intervention (week 8)47.55 score on a scaleStandard Deviation 9.17
No Intervention ControlChange in Depression3-month followup47.13 score on a scaleStandard Deviation 5.93
No Intervention ControlChange in Depressionbaseline48.22 score on a scaleStandard Deviation 7.56
Secondary

Change in Interleukin-10

Blood spot analysis of interleukin-10.

Time frame: baseline, post-intervention (8 weeks), 3 month followup

Population: Numbers at post-intervention and 3-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Interleukin-10post-intervention (week 8).20 units on a scale pg/mLStandard Deviation 0.16
Mindfulness-Based Resilience Training (MBRT)Change in Interleukin-10baseline.27 units on a scale pg/mLStandard Deviation 0.27
Mindfulness-Based Resilience Training (MBRT)Change in Interleukin-103-month followup.21 units on a scale pg/mLStandard Deviation 0.13
Stress Management Education (SME)Change in Interleukin-10post-intervention (week 8).17 units on a scale pg/mLStandard Deviation 0.1
Stress Management Education (SME)Change in Interleukin-10baseline.28 units on a scale pg/mLStandard Deviation 0.2
Stress Management Education (SME)Change in Interleukin-103-month followup.18 units on a scale pg/mLStandard Deviation 0.11
No Intervention ControlChange in Interleukin-10baseline.16 units on a scale pg/mLStandard Deviation 0.08
No Intervention ControlChange in Interleukin-103-month followup.11 units on a scale pg/mLStandard Deviation 0.07
No Intervention ControlChange in Interleukin-10post-intervention (week 8).13 units on a scale pg/mLStandard Deviation 0.12
Secondary

Change in Interleukin-6

Blood spot analysis of interleukin-6.

Time frame: baseline, post-intervention (8 weeks), 3 month followup

Population: Numbers at post-intervention and 3-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Interleukin-6post-intervention (week 8).58 units on a scale pg/mLStandard Deviation 0.91
Mindfulness-Based Resilience Training (MBRT)Change in Interleukin-6baseline.55 units on a scale pg/mLStandard Deviation 0.87
Mindfulness-Based Resilience Training (MBRT)Change in Interleukin-63-month followup.37 units on a scale pg/mLStandard Deviation 0.28
Stress Management Education (SME)Change in Interleukin-6post-intervention (week 8).51 units on a scale pg/mLStandard Deviation 0.45
Stress Management Education (SME)Change in Interleukin-6baseline.37 units on a scale pg/mLStandard Deviation 0.3
Stress Management Education (SME)Change in Interleukin-63-month followup.39 units on a scale pg/mLStandard Deviation 0.29
No Intervention ControlChange in Interleukin-6baseline.28 units on a scale pg/mLStandard Deviation 0.12
No Intervention ControlChange in Interleukin-63-month followup.23 units on a scale pg/mLStandard Deviation 0.11
No Intervention ControlChange in Interleukin-6post-intervention (week 8).23 units on a scale pg/mLStandard Deviation 0.38
Secondary

Change in Interoceptive Awareness

Multidimensional Assessment of Interoceptive Awareness-II. Scores range from 1-6, with higher scores indicating greater interoceptive awareness.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Interoceptive Awarenessbaseline3.89 score on a scaleStandard Deviation 0.64
Mindfulness-Based Resilience Training (MBRT)Change in Interoceptive Awarenesspost-intervention (week 8)4.19 score on a scaleStandard Deviation 0.5
Mindfulness-Based Resilience Training (MBRT)Change in Interoceptive Awareness3-month followup4.22 score on a scaleStandard Deviation 0.61
Mindfulness-Based Resilience Training (MBRT)Change in Interoceptive Awareness6-month followup4.19 score on a scaleStandard Deviation 0.55
Stress Management Education (SME)Change in Interoceptive Awareness6-month followup3.87 score on a scaleStandard Deviation 0.79
Stress Management Education (SME)Change in Interoceptive Awarenessbaseline3.77 score on a scaleStandard Deviation 0.61
Stress Management Education (SME)Change in Interoceptive Awareness3-month followup4.00 score on a scaleStandard Deviation 0.5
Stress Management Education (SME)Change in Interoceptive Awarenesspost-intervention (week 8)3.82 score on a scaleStandard Deviation 0.52
No Intervention ControlChange in Interoceptive Awareness6-month followup3.62 score on a scaleStandard Deviation 0.59
No Intervention ControlChange in Interoceptive Awarenesspost-intervention (week 8)3.89 score on a scaleStandard Deviation 0.55
No Intervention ControlChange in Interoceptive Awareness3-month followup3.67 score on a scaleStandard Deviation 0.66
No Intervention ControlChange in Interoceptive Awarenessbaseline3.62 score on a scaleStandard Deviation 0.51
Secondary

Change in Mindfulness

Five Facet Mindfulness Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater mindfulness.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Mindfulnesspost-intervention (week 8)3.56 score on a scaleStandard Deviation 0.45
Mindfulness-Based Resilience Training (MBRT)Change in Mindfulnessbaseline3.48 score on a scaleStandard Deviation 0.68
Mindfulness-Based Resilience Training (MBRT)Change in Mindfulness3-month followup3.60 score on a scaleStandard Deviation 0.6
Mindfulness-Based Resilience Training (MBRT)Change in Mindfulness6-month followup3.62 score on a scaleStandard Deviation 0.45
Stress Management Education (SME)Change in Mindfulnesspost-intervention (week 8)3.61 score on a scaleStandard Deviation 0.41
Stress Management Education (SME)Change in Mindfulness6-month followup3.51 score on a scaleStandard Deviation 0.45
Stress Management Education (SME)Change in Mindfulness3-month followup3.51 score on a scaleStandard Deviation 0.29
Stress Management Education (SME)Change in Mindfulnessbaseline3.53 score on a scaleStandard Deviation 0.47
No Intervention ControlChange in Mindfulness3-month followup3.65 score on a scaleStandard Deviation 0.58
No Intervention ControlChange in Mindfulnesspost-intervention (week 8)3.56 score on a scaleStandard Deviation 0.84
No Intervention ControlChange in Mindfulnessbaseline3.63 score on a scaleStandard Deviation 0.74
No Intervention ControlChange in Mindfulness6-month followup3.61 score on a scaleStandard Deviation 0.64
Secondary

Change in Perceived Stress

Perceived Stress Scale-10. Scores range from 0-40, with higher scores indicating greater perceived stress.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Perceived Stressbaseline24.45 score on a scaleStandard Deviation 6.13
Mindfulness-Based Resilience Training (MBRT)Change in Perceived Stresspost-intervention (week 8)23.39 score on a scaleStandard Deviation 5.71
Mindfulness-Based Resilience Training (MBRT)Change in Perceived Stress3-month followup22.66 score on a scaleStandard Deviation 6.61
Mindfulness-Based Resilience Training (MBRT)Change in Perceived Stress6-month followup22.97 score on a scaleStandard Deviation 6.31
Stress Management Education (SME)Change in Perceived Stress6-month followup24.00 score on a scaleStandard Deviation 4.23
Stress Management Education (SME)Change in Perceived Stressbaseline23.16 score on a scaleStandard Deviation 4.6
Stress Management Education (SME)Change in Perceived Stress3-month followup23.65 score on a scaleStandard Deviation 5.9
Stress Management Education (SME)Change in Perceived Stresspost-intervention (week 8)22.05 score on a scaleStandard Deviation 4.39
No Intervention ControlChange in Perceived Stress6-month followup23.00 score on a scaleStandard Deviation 5.48
No Intervention ControlChange in Perceived Stresspost-intervention (week 8)22.86 score on a scaleStandard Deviation 7.37
No Intervention ControlChange in Perceived Stress3-month followup22.47 score on a scaleStandard Deviation 7.26
No Intervention ControlChange in Perceived Stressbaseline22.93 score on a scaleStandard Deviation 6.52
Secondary

Change in Psychological Resilience

Brief Resilience Scale. Scores range from 1-5, with higher scores indicating greater resilience.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Psychological ResilienceBaseline3.71 score on a scaleStandard Deviation 0.74
Mindfulness-Based Resilience Training (MBRT)Change in Psychological Resiliencepost-intervention4.08 score on a scaleStandard Deviation 0.65
Mindfulness-Based Resilience Training (MBRT)Change in Psychological Resilience3-month followup3.98 score on a scaleStandard Deviation 0.72
Mindfulness-Based Resilience Training (MBRT)Change in Psychological Resilience6-month followup4.04 score on a scaleStandard Deviation 0.66
Stress Management Education (SME)Change in Psychological Resilience6-month followup4.01 score on a scaleStandard Deviation 0.52
Stress Management Education (SME)Change in Psychological ResilienceBaseline4.00 score on a scaleStandard Deviation 0.47
Stress Management Education (SME)Change in Psychological Resilience3-month followup4.10 score on a scaleStandard Deviation 0.41
Stress Management Education (SME)Change in Psychological Resiliencepost-intervention4.11 score on a scaleStandard Deviation 0.49
No Intervention ControlChange in Psychological Resilience6-month followup3.83 score on a scaleStandard Deviation 0.67
No Intervention ControlChange in Psychological Resiliencepost-intervention3.90 score on a scaleStandard Deviation 0.67
No Intervention ControlChange in Psychological Resilience3-month followup4.03 score on a scaleStandard Deviation 0.41
No Intervention ControlChange in Psychological ResilienceBaseline3.99 score on a scaleStandard Deviation 0.4
Secondary

Change in Self-Compassion

Self-Compassion Scale-Short Form. Scores range from 1-5, with higher scores indicating greater self-compassion.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Self-Compassionbaseline3.35 score on a scaleStandard Deviation 0.66
Mindfulness-Based Resilience Training (MBRT)Change in Self-Compassionpost-intervention (week 8)3.52 score on a scaleStandard Deviation 0.64
Mindfulness-Based Resilience Training (MBRT)Change in Self-Compassion3-month followup3.61 score on a scaleStandard Deviation 0.57
Mindfulness-Based Resilience Training (MBRT)Change in Self-Compassion6-month followup3.66 score on a scaleStandard Deviation 0.53
Stress Management Education (SME)Change in Self-Compassion6-month followup3.45 score on a scaleStandard Deviation 0.55
Stress Management Education (SME)Change in Self-Compassionbaseline3.52 score on a scaleStandard Deviation 0.58
Stress Management Education (SME)Change in Self-Compassion3-month followup3.56 score on a scaleStandard Deviation 0.52
Stress Management Education (SME)Change in Self-Compassionpost-intervention (week 8)3.54 score on a scaleStandard Deviation 0.59
No Intervention ControlChange in Self-Compassion6-month followup3.38 score on a scaleStandard Deviation 0.76
No Intervention ControlChange in Self-Compassionpost-intervention (week 8)3.40 score on a scaleStandard Deviation 0.83
No Intervention ControlChange in Self-Compassion3-month followup3.41 score on a scaleStandard Deviation 0.76
No Intervention ControlChange in Self-Compassionbaseline3.16 score on a scaleStandard Deviation 0.73
Secondary

Change in Sleep Disturbance

Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance. Scores range from 32-76, with higher scores indicating greater sleep disturbance.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Sleep Disturbancebaseline54.35 score on a scaleStandard Deviation 7.32
Mindfulness-Based Resilience Training (MBRT)Change in Sleep Disturbancepost-intervention (week 8)52.03 score on a scaleStandard Deviation 7.72
Mindfulness-Based Resilience Training (MBRT)Change in Sleep Disturbance3-month followup51.45 score on a scaleStandard Deviation 7.87
Mindfulness-Based Resilience Training (MBRT)Change in Sleep Disturbance6-month followup51.36 score on a scaleStandard Deviation 6.62
Stress Management Education (SME)Change in Sleep Disturbance6-month followup51.51 score on a scaleStandard Deviation 7.78
Stress Management Education (SME)Change in Sleep Disturbancebaseline52.48 score on a scaleStandard Deviation 7.8
Stress Management Education (SME)Change in Sleep Disturbance3-month followup52.93 score on a scaleStandard Deviation 7.65
Stress Management Education (SME)Change in Sleep Disturbancepost-intervention (week 8)54.38 score on a scaleStandard Deviation 6.44
No Intervention ControlChange in Sleep Disturbance6-month followup52.90 score on a scaleStandard Deviation 9.79
No Intervention ControlChange in Sleep Disturbancepost-intervention (week 8)53.11 score on a scaleStandard Deviation 9.26
No Intervention ControlChange in Sleep Disturbance3-month followup53.85 score on a scaleStandard Deviation 7.97
No Intervention ControlChange in Sleep Disturbancebaseline53.48 score on a scaleStandard Deviation 9.88
Secondary

Change in Suicidal Thinking

Concise Heath Risk Tracking Scale-Self-Report. Scores range from 7-35, with higher scores indicating greater suicidal ideation.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Suicidal Thinkingbaseline8.91 score on a scaleStandard Deviation 2.39
Mindfulness-Based Resilience Training (MBRT)Change in Suicidal Thinkingpost-intervention (week 8)8.74 score on a scaleStandard Deviation 2.67
Mindfulness-Based Resilience Training (MBRT)Change in Suicidal Thinking3-month followup8.90 score on a scaleStandard Deviation 3.34
Mindfulness-Based Resilience Training (MBRT)Change in Suicidal Thinking6-month followup8.07 score on a scaleStandard Deviation 1.73
Stress Management Education (SME)Change in Suicidal Thinking6-month followup8.44 score on a scaleStandard Deviation 2.64
Stress Management Education (SME)Change in Suicidal Thinkingbaseline8.16 score on a scaleStandard Deviation 2.23
Stress Management Education (SME)Change in Suicidal Thinking3-month followup8.58 score on a scaleStandard Deviation 2.62
Stress Management Education (SME)Change in Suicidal Thinkingpost-intervention (week 8)8.05 score on a scaleStandard Deviation 2.25
No Intervention ControlChange in Suicidal Thinking6-month followup8.21 score on a scaleStandard Deviation 2.19
No Intervention ControlChange in Suicidal Thinkingpost-intervention (week 8)9.57 score on a scaleStandard Deviation 4.18
No Intervention ControlChange in Suicidal Thinking3-month followup8.27 score on a scaleStandard Deviation 1.98
No Intervention ControlChange in Suicidal Thinkingbaseline8.20 score on a scaleStandard Deviation 2.65
Secondary

Change in Sustained Attention

Sustained Attention to Response Task. A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amongst a background of frequent non-targets. Increased errors indicates less sustained attention.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Sustained Attentionbaseline17.03 errorsStandard Deviation 13.5
Mindfulness-Based Resilience Training (MBRT)Change in Sustained Attentionpost-intervention (week 8)15.86 errorsStandard Deviation 30.28
Mindfulness-Based Resilience Training (MBRT)Change in Sustained Attention3-month followup15.33 errorsStandard Deviation 18.88
Mindfulness-Based Resilience Training (MBRT)Change in Sustained Attention6-month followup15.88 errorsStandard Deviation 27.22
Stress Management Education (SME)Change in Sustained Attention6-month followup9.53 errorsStandard Deviation 6.89
Stress Management Education (SME)Change in Sustained Attentionbaseline16.00 errorsStandard Deviation 53.1
Stress Management Education (SME)Change in Sustained Attention3-month followup9.30 errorsStandard Deviation 11.06
Stress Management Education (SME)Change in Sustained Attentionpost-intervention (week 8)13.50 errorsStandard Deviation 20
No Intervention ControlChange in Sustained Attention6-month followup29.23 errorsStandard Deviation 63.9
No Intervention ControlChange in Sustained Attentionpost-intervention (week 8)30.71 errorsStandard Deviation 30.01
No Intervention ControlChange in Sustained Attention3-month followup25.35 errorsStandard Deviation 20.48
No Intervention ControlChange in Sustained Attentionbaseline31.42 errorsStandard Deviation 37.16
Secondary

Change in Trauma Symptoms

PTSD Checklist for DSM-5. Scores ranges from 0-80, with higher scores indicating greater PTSD symptoms.

Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

Population: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Trauma Symptomsbaseline37.76 score on a scaleStandard Deviation 14.39
Mindfulness-Based Resilience Training (MBRT)Change in Trauma Symptomspost-intervention (week 8)34.32 score on a scaleStandard Deviation 11.69
Mindfulness-Based Resilience Training (MBRT)Change in Trauma Symptoms3-month followup34.07 score on a scaleStandard Deviation 12.57
Mindfulness-Based Resilience Training (MBRT)Change in Trauma Symptoms6-month followup31.93 score on a scaleStandard Deviation 11.74
Stress Management Education (SME)Change in Trauma Symptoms6-month followup31.61 score on a scaleStandard Deviation 11.08
Stress Management Education (SME)Change in Trauma Symptomsbaseline33.36 score on a scaleStandard Deviation 9.12
Stress Management Education (SME)Change in Trauma Symptoms3-month followup32.29 score on a scaleStandard Deviation 10.26
Stress Management Education (SME)Change in Trauma Symptomspost-intervention (week 8)30.74 score on a scaleStandard Deviation 8.77
No Intervention ControlChange in Trauma Symptoms6-month followup32.07 score on a scaleStandard Deviation 13.09
No Intervention ControlChange in Trauma Symptomspost-intervention (week 8)33.36 score on a scaleStandard Deviation 15.35
No Intervention ControlChange in Trauma Symptoms3-month followup33.20 score on a scaleStandard Deviation 11.94
No Intervention ControlChange in Trauma Symptomsbaseline31.53 score on a scaleStandard Deviation 12.13
Secondary

Change in Tumor Necrosis Factor-alpha

Blood spot analysis of tumor necrosis factor-alpha.

Time frame: baseline, post-intervention (8 weeks), 3 month followup

Population: Numbers at post-intervention and 3-month followup reflect attrition or participants or lost to followup.

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Change in Tumor Necrosis Factor-alphapost-intervention (week 8)2.02 units on a scale pg/mLStandard Deviation 0.68
Mindfulness-Based Resilience Training (MBRT)Change in Tumor Necrosis Factor-alphabaseline2.25 units on a scale pg/mLStandard Deviation 0.81
Mindfulness-Based Resilience Training (MBRT)Change in Tumor Necrosis Factor-alpha3-month followup1.76 units on a scale pg/mLStandard Deviation 0.61
Stress Management Education (SME)Change in Tumor Necrosis Factor-alphapost-intervention (week 8)1.71 units on a scale pg/mLStandard Deviation 0.39
Stress Management Education (SME)Change in Tumor Necrosis Factor-alphabaseline2.20 units on a scale pg/mLStandard Deviation 0.66
Stress Management Education (SME)Change in Tumor Necrosis Factor-alpha3-month followup1.71 units on a scale pg/mLStandard Deviation 0.35
No Intervention ControlChange in Tumor Necrosis Factor-alphabaseline1.87 units on a scale pg/mLStandard Deviation 0.45
No Intervention ControlChange in Tumor Necrosis Factor-alpha3-month followup1.66 units on a scale pg/mLStandard Deviation 0.27
No Intervention ControlChange in Tumor Necrosis Factor-alphapost-intervention (week 8)1.70 units on a scale pg/mLStandard Deviation 0.62
Secondary

Global Impression of Change

Clinical Global Impressions Scale. Measure of perceived change in functioning as a result of the intervention. Scores range from 3-21, with higher scores indicating a greater impression of change. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.

Time frame: post-intervention (8 weeks)

ArmMeasureValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Global Impression of Change16.19 score on a scaleStandard Deviation 2.1
Stress Management Education (SME)Global Impression of Change14.22 score on a scaleStandard Deviation 1.66
Secondary

Treatment Acceptability

Postcourse satisfaction survey. Scores range from 4-16, with higher scores indicating greater treatment acceptability. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.

Time frame: post-intervention (8 weeks)

ArmMeasureValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Treatment Acceptability13.94 score on a scaleStandard Deviation 2.43
Stress Management Education (SME)Treatment Acceptability12.28 score on a scaleStandard Deviation 2.52
Secondary

Treatment Compliance

Objective assessment of duration of homework practice. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.

Time frame: post-intervention (8 weeks)

ArmMeasureValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Treatment Compliance211.66 minutesStandard Deviation 186.62
Stress Management Education (SME)Treatment Compliance65.45 minutesStandard Deviation 68.45
Secondary

Treatment Expectancy and Credibility

Expectancy/Credibility Questionnaire. Scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Scores range from 7-21, with higher scores indicating greater expectancy and credibility.

Time frame: baseline

ArmMeasureValue (MEAN)Dispersion
Mindfulness-Based Resilience Training (MBRT)Treatment Expectancy and Credibility15.61 score on a scaleStandard Deviation 3.75
Stress Management Education (SME)Treatment Expectancy and Credibility15.60 score on a scaleStandard Deviation 2.9
No Intervention ControlTreatment Expectancy and Credibility15.53 score on a scaleStandard Deviation 2.2

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026