Trauma and Stressor Related Disorders
Conditions
Brief summary
Compared to U.S. urban counterparts, rural residents face major barriers to using health care services. Challenges include shortages of services, long distances to existing services, and stigma regarding mental illness in isolated communities. These difficulties hold true for Montana, but especially for adolescents. The objective of A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana is to improve stress-related mental and physical health outcomes for adolescents and educators in rural Montana through school-based, trauma-informed yoga exercises. This project builds on investigators' previous research (including a two-year CAIRHE pilot study, 2019-21) to promote positive youth development by simultaneously intervening with students and teachers with a trauma-informed yoga intervention. Geographic isolation and resulting lack of resources for many Montanan schools indicates a need for novel, school-centered interventions to address the needs of rural adolescents; yoga can benefit youth and teacher wellbeing.
Detailed description
In Year 2, investigators will expand the study to pilot test a remote delivery for students and teachers in rural schools through virtual delivery (in addition to an in-person high school student intervention at the school district of Aim 1. Primary outcomes for teachers will assess career satisfaction/self-efficacy; primary outcomes for students will assess depression/anxiety symptomology. Effects on secondary mental/physical health outcomes will be drawn from survey results, cortisol levels, and heart rate variability measures (collected pre/post). Investigators will then determine which intervention design was more effective with students (in-person vs. remote) between the two years of this feasibility study through an outcome evaluation. Comparisons of mental and physical health outcomes will be examined by the research team using cohort data drawn from participants' physiological data and survey results. The short-term public health impact of this study is to improve the mental and physical health of rural Montana youth and teachers through a novel, school-based intervention. If successful, this study's long-term public health impact will reduce rates of anxiety and depression and improve physical health in geographically isolated settings.
Interventions
BEHAVIORALTrauma-Informed Yoga
Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
Sponsors
National Institute of General Medical Sciences (NIGMS)
Montana State University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Any teacher currently employed by the Livingston or Gardiner school district who wishes to participate in the intervention (up to 45 participants) * Any freshmen student enrolled in pre-selected PE classes at Park High School in Livingston Montana * Any PE student enrolled in pre-selected PE classes at Gardiner High School in Gardiner Montana
Exclusion criteria
* Any students that are not enrolled in pre-selected PE classes at Park or Gardiner High Schools in Southwest Montana
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol Levels | Pre-Intervention, first day of Week 1 and post-intervention, last day of Week 6 | Participants will provide a saliva sample in which cortisol levels will be analyzed through salivary assay kits (through Salimetrics.com). Samples will be collected on the first day of the intervention (week 1) and on the last day of the intervention (week 6) to determine if the intervention has improved stress levels (as indicated by a reduction in cortisol levels). A biostatistician will provide analysis and conclusion of these samples at the conclusion of the study |
| Patient Health Questionnaire | Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6 | This 9 item questionnaire is designed to evaluate severity of depressive symptoms in participants. It is scored on a Likert scale from 0 (not at all) to 3 (nearly every day) on items linked to depression indicators. The minimum score is a 0 and the maximum score is a 27, and a reduction in score from pre- to post-assessment indicates an improvement in symptomology. |
| Generalized Anxiety Disorder-7 Anxiety Scale | Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6 | This 7 item questionnaire is based on a likert scale of 0 (not at all) to 3 (nearly every day) for items related to anxiety disorders. The lowest score is a zero and the maximum score is a 21. A reduction in score from pre- to post-assessment indicates an improvement in symptomology. |
| Heart Rate Variability | Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6 | Participants enrolled will have their heart rate data measured by the Biopac BioNomadix PPG & EDA System with Pulse Transduce to determine heart rate variability. Due to circumstances beyond the research team's control, only teachers at one study site were able to provide heart rate variability data, so fewer than our total enrollment was able to provide this data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Connor-Davidson Resilience Scale (CD-RISC) | Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6 | The CD-RISC 10 is a unidimensional self-reported scale consisting of 10-items measuring resilience. Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4. The minimum score possible is a 0 and the maximum score is a 40. A higher score indicates an improvement (increased resilience). |
| PTSD Checklist for DSM-5 (PCL-5) | Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6 | Teachers will complete this self-reporting scale consisting of 20 items measuring traumatic stress symptoms in the previous month. Items are scored on a Likert scale from 0 (not at all) to 4 (extremely). The minimum score possible is a 0 and the maximum score is an 80. Lower scores indicate improvements in traumatic stress symptoms, and higher scores worsening levels of traumatic stress in respondents. |
| Professional Quality of Life Index (Pro-QOL) | Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6 | Teachers will complete this self-reporting scale consisting of 30 items measuring levels of compassion satisfaction, secondary trauma, and professional burnout. Respondents rate items on a 5 point Likert scale ranging from 0 (never) to 5 (very often). Scores within each subscale were added together to produce a mean for each subscale; subscale means were then averaged together for a total mean score. The minimum score for each subscale is a 0, and the maximum score for each subscale is a 50. Reduced scores indicate an improvement in burnout and secondary trauma. |
| Teachers' Sense of Self-Efficacy (Short Form) | Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6 | Teachers will complete this self-reporting scale consisting of 12 items measuring levels of self-perceived levels of impact on student engagement, instructional strategies, and classroom management. Respondents rate items on a 9 point Likert scale ranging from 0 (nothing) to 9 (a great deal). The minimum score possible is a 0 and the maximum score is a 90. Subscale scores were averaged together to produce a single mean. Higher mean scores indicate improvements in self-perceptions of self-efficacy. |
| PROMIS Sleep Disturbance Scales | Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6 | Participants will complete this self-reporting scale consisting of 8 items measuring perceived levels of sleep quality over the previous 7 days. Items are scored on a Likert scale ranging from 1 (not at all) to 5 (very much). The minimum score possible is 8 and the maximum score is a 40. Lower scores indicate an improvement in sleep quality, and higher scores indicate increased severity of sleep disturbances. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High School Students: Remote Delivery Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions | 22 |
| High School Students: Face-to-Face Delivery Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions | 18 |
| Teachers: Remote Delivery Trauma-Informed Yoga: Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions | 43 |
| Total | 83 |
Baseline characteristics
| Characteristic | High School Students: Remote Delivery | High School Students: Face-to-Face Delivery | Teachers: Remote Delivery | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 22 Participants | 18 Participants | 0 Participants | 40 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 42 Participants | 42 Participants |
| Cortisol Levels | 0.3 micrograms per deciliter STANDARD_DEVIATION 0.4 | .43 micrograms per deciliter STANDARD_DEVIATION 0.38 | .16 micrograms per deciliter STANDARD_DEVIATION 0.11 | 0.3 micrograms per deciliter STANDARD_DEVIATION 0.3 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 37 Participants | 57 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 6 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 18 | 0 / 43 |
| other Total, other adverse events | 0 / 22 | 0 / 18 | 0 / 43 |
| serious Total, serious adverse events | 0 / 22 | 0 / 18 | 0 / 43 |
Outcome results
Primary
Generalized Anxiety Disorder-7 Anxiety Scale
This 7 item questionnaire is based on a likert scale of 0 (not at all) to 3 (nearly every day) for items related to anxiety disorders. The lowest score is a zero and the maximum score is a 21. A reduction in score from pre- to post-assessment indicates an improvement in symptomology.
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High School Students: Remote Delivery | Generalized Anxiety Disorder-7 Anxiety Scale | Pre-Intervention: First day of Week 1 | 9.45 score on a scale | Standard Deviation 5.62 |
| High School Students: Remote Delivery | Generalized Anxiety Disorder-7 Anxiety Scale | Post-Intervention, last day of Week 6 | 8.22 score on a scale | Standard Deviation 4.57 |
| High School Students: Face-to-Face Delivery | Generalized Anxiety Disorder-7 Anxiety Scale | Pre-Intervention: First day of Week 1 | 7.84 score on a scale | Standard Deviation 5.36 |
| High School Students: Face-to-Face Delivery | Generalized Anxiety Disorder-7 Anxiety Scale | Post-Intervention, last day of Week 6 | 6.06 score on a scale | Standard Deviation 5.02 |
| Teachers: Remote Delivery | Generalized Anxiety Disorder-7 Anxiety Scale | Pre-Intervention: First day of Week 1 | 7.9 score on a scale | Standard Deviation 5.1 |
| Teachers: Remote Delivery | Generalized Anxiety Disorder-7 Anxiety Scale | Post-Intervention, last day of Week 6 | 5.4 score on a scale | Standard Deviation 4.4 |
Primary
Heart Rate Variability
Participants enrolled will have their heart rate data measured by the Biopac BioNomadix PPG & EDA System with Pulse Transduce to determine heart rate variability. Due to circumstances beyond the research team's control, only teachers at one study site were able to provide heart rate variability data, so fewer than our total enrollment was able to provide this data.
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High School Students: Remote Delivery | Heart Rate Variability | Pre-Intervention: First day of Week 1 | 72.55 beats per minute (bpm) | Standard Deviation 13.27 |
| High School Students: Remote Delivery | Heart Rate Variability | Post-Intervention, last day of Week 6 | 73.34 beats per minute (bpm) | Standard Deviation 11.73 |
| High School Students: Face-to-Face Delivery | Heart Rate Variability | Pre-Intervention: First day of Week 1 | 70.29 beats per minute (bpm) | Standard Deviation 10.28 |
| High School Students: Face-to-Face Delivery | Heart Rate Variability | Post-Intervention, last day of Week 6 | 69.00 beats per minute (bpm) | Standard Deviation 8.85 |
| Teachers: Remote Delivery | Heart Rate Variability | Post-Intervention, last day of Week 6 | 70.87 beats per minute (bpm) | Standard Deviation 12.41 |
| Teachers: Remote Delivery | Heart Rate Variability | Pre-Intervention: First day of Week 1 | 68.46 beats per minute (bpm) | Standard Deviation 11 |
Primary
Patient Health Questionnaire
This 9 item questionnaire is designed to evaluate severity of depressive symptoms in participants. It is scored on a Likert scale from 0 (not at all) to 3 (nearly every day) on items linked to depression indicators. The minimum score is a 0 and the maximum score is a 27, and a reduction in score from pre- to post-assessment indicates an improvement in symptomology.
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High School Students: Remote Delivery | Patient Health Questionnaire | Pre-Intervention: First day of Week 1 | 11.84 score on a scale | Standard Deviation 7.02 |
| High School Students: Remote Delivery | Patient Health Questionnaire | Post-Intervention, last day of Week 6 | 8.67 score on a scale | Standard Deviation 5.86 |
| High School Students: Face-to-Face Delivery | Patient Health Questionnaire | Pre-Intervention: First day of Week 1 | 6.47 score on a scale | Standard Deviation 4.6 |
| High School Students: Face-to-Face Delivery | Patient Health Questionnaire | Post-Intervention, last day of Week 6 | 4.92 score on a scale | Standard Deviation 4.69 |
| Teachers: Remote Delivery | Patient Health Questionnaire | Post-Intervention, last day of Week 6 | 4.5 score on a scale | Standard Deviation 3.6 |
| Teachers: Remote Delivery | Patient Health Questionnaire | Pre-Intervention: First day of Week 1 | 7.1 score on a scale | Standard Deviation 4.8 |
Primary
Salivary Cortisol Levels
Participants will provide a saliva sample in which cortisol levels will be analyzed through salivary assay kits (through Salimetrics.com). Samples will be collected on the first day of the intervention (week 1) and on the last day of the intervention (week 6) to determine if the intervention has improved stress levels (as indicated by a reduction in cortisol levels). A biostatistician will provide analysis and conclusion of these samples at the conclusion of the study
Time frame: Pre-Intervention, first day of Week 1 and post-intervention, last day of Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High School Students: Remote Delivery | Salivary Cortisol Levels | Post-Intervention: Last day of week 6 | .33 micrograms per deciliter | Standard Deviation 0.2 |
| High School Students: Remote Delivery | Salivary Cortisol Levels | Pre-Intervention: First day of week 1 | .30 micrograms per deciliter | Standard Deviation 0.4 |
| High School Students: Face-to-Face Delivery | Salivary Cortisol Levels | Pre-Intervention: First day of week 1 | .43 micrograms per deciliter | Standard Deviation 0.38 |
| High School Students: Face-to-Face Delivery | Salivary Cortisol Levels | Post-Intervention: Last day of week 6 | .25 micrograms per deciliter | Standard Deviation 0.13 |
| Teachers: Remote Delivery | Salivary Cortisol Levels | Pre-Intervention: First day of week 1 | .16 micrograms per deciliter | Standard Deviation 0.11 |
| Teachers: Remote Delivery | Salivary Cortisol Levels | Post-Intervention: Last day of week 6 | .15 micrograms per deciliter | Standard Deviation 0.11 |
Secondary
Connor-Davidson Resilience Scale (CD-RISC)
The CD-RISC 10 is a unidimensional self-reported scale consisting of 10-items measuring resilience. Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4. The minimum score possible is a 0 and the maximum score is a 40. A higher score indicates an improvement (increased resilience).
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High School Students: Remote Delivery | Connor-Davidson Resilience Scale (CD-RISC) | Pre-Intervention: First day of Week 1 | 26.64 score on a scale | Standard Deviation 8.17 |
| High School Students: Remote Delivery | Connor-Davidson Resilience Scale (CD-RISC) | Post-Intervention, last day of Week 6 | 25.56 score on a scale | Standard Deviation 7.76 |
| High School Students: Face-to-Face Delivery | Connor-Davidson Resilience Scale (CD-RISC) | Pre-Intervention: First day of Week 1 | 25.68 score on a scale | Standard Deviation 6.52 |
| High School Students: Face-to-Face Delivery | Connor-Davidson Resilience Scale (CD-RISC) | Post-Intervention, last day of Week 6 | 27.33 score on a scale | Standard Deviation 6.06 |
| Teachers: Remote Delivery | Connor-Davidson Resilience Scale (CD-RISC) | Pre-Intervention: First day of Week 1 | 28.8 score on a scale | Standard Deviation 4.9 |
| Teachers: Remote Delivery | Connor-Davidson Resilience Scale (CD-RISC) | Post-Intervention, last day of Week 6 | 29.2 score on a scale | Standard Deviation 4.3 |
Secondary
Professional Quality of Life Index (Pro-QOL)
Teachers will complete this self-reporting scale consisting of 30 items measuring levels of compassion satisfaction, secondary trauma, and professional burnout. Respondents rate items on a 5 point Likert scale ranging from 0 (never) to 5 (very often). Scores within each subscale were added together to produce a mean for each subscale; subscale means were then averaged together for a total mean score. The minimum score for each subscale is a 0, and the maximum score for each subscale is a 50. Reduced scores indicate an improvement in burnout and secondary trauma.
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High School Students: Remote Delivery | Professional Quality of Life Index (Pro-QOL) | Pre-Intervention: First day of Week 1 | 32.6 score on a scale | Standard Deviation 5.27 |
| High School Students: Remote Delivery | Professional Quality of Life Index (Pro-QOL) | Post-Intervention, last day of Week 6 | 31.27 score on a scale | Standard Deviation 5.07 |
Secondary
PROMIS Sleep Disturbance Scales
Participants will complete this self-reporting scale consisting of 8 items measuring perceived levels of sleep quality over the previous 7 days. Items are scored on a Likert scale ranging from 1 (not at all) to 5 (very much). The minimum score possible is 8 and the maximum score is a 40. Lower scores indicate an improvement in sleep quality, and higher scores indicate increased severity of sleep disturbances.
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High School Students: Remote Delivery | PROMIS Sleep Disturbance Scales | Pre-Intervention: First day of Week 1 | 22.27 score on a scale | Standard Deviation 2.8 |
| High School Students: Remote Delivery | PROMIS Sleep Disturbance Scales | Post-Intervention, last day of Week 6 | 23.39 score on a scale | Standard Deviation 3.45 |
| High School Students: Face-to-Face Delivery | PROMIS Sleep Disturbance Scales | Pre-Intervention: First day of Week 1 | 23.00 score on a scale | Standard Deviation 3.18 |
| High School Students: Face-to-Face Delivery | PROMIS Sleep Disturbance Scales | Post-Intervention, last day of Week 6 | 22.28 score on a scale | Standard Deviation 2.47 |
| Teachers: Remote Delivery | PROMIS Sleep Disturbance Scales | Pre-Intervention: First day of Week 1 | 22.1 score on a scale | Standard Deviation 2.9 |
| Teachers: Remote Delivery | PROMIS Sleep Disturbance Scales | Post-Intervention, last day of Week 6 | 21.2 score on a scale | Standard Deviation 2.9 |
Secondary
PTSD Checklist for DSM-5 (PCL-5)
Teachers will complete this self-reporting scale consisting of 20 items measuring traumatic stress symptoms in the previous month. Items are scored on a Likert scale from 0 (not at all) to 4 (extremely). The minimum score possible is a 0 and the maximum score is an 80. Lower scores indicate improvements in traumatic stress symptoms, and higher scores worsening levels of traumatic stress in respondents.
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High School Students: Remote Delivery | PTSD Checklist for DSM-5 (PCL-5) | Pre-Intervention: First day of Week 1 | 19.5 score on a scale | Standard Deviation 12.9 |
| High School Students: Remote Delivery | PTSD Checklist for DSM-5 (PCL-5) | Post-Intervention, last day of Week 6 | 12.8 score on a scale | Standard Deviation 10 |
Secondary
Teachers' Sense of Self-Efficacy (Short Form)
Teachers will complete this self-reporting scale consisting of 12 items measuring levels of self-perceived levels of impact on student engagement, instructional strategies, and classroom management. Respondents rate items on a 9 point Likert scale ranging from 0 (nothing) to 9 (a great deal). The minimum score possible is a 0 and the maximum score is a 90. Subscale scores were averaged together to produce a single mean. Higher mean scores indicate improvements in self-perceptions of self-efficacy.
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High School Students: Remote Delivery | Teachers' Sense of Self-Efficacy (Short Form) | Pre-Intervention: First day of Week 1 | 83.2 score on a scale | Standard Deviation 11.8 |
| High School Students: Remote Delivery | Teachers' Sense of Self-Efficacy (Short Form) | Post-Intervention, last day of Week 6 | 81.5 score on a scale | Standard Deviation 12.4 |