Trial Outcomes & Findings for A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana (NCT NCT05085392)
NCT ID: NCT05085392
Last Updated: 2023-07-05
Results Overview
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, halfway through the intervention, and on the last day of the intervention 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
COMPLETED
NA
20 participants
Pre-Intervention (Baseline), Post-Intervention (Week 6)
2023-07-05
Participant Flow
Participant milestones
| Measure |
Experimental Group Yoga
20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group Yoga
n=20 Participants
20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=20 Participants
|
|
Cortisol Level
|
0.07 micrograms per deciliter
STANDARD_DEVIATION 0.07 • n=20 Participants
|
PRIMARY outcome
Timeframe: Pre-Intervention (Baseline), Post-Intervention (Week 6)Population: 20 educators in a southwestern Montana school district
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, halfway through the intervention, and on the last day of the intervention 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
Outcome measures
| Measure |
Experimental Group Yoga
n=20 Participants
20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session
|
|---|---|
|
Change in Salivary Cortisol Levels
Post-Intervention
|
0.11 ug/dl
Standard Deviation 0.08
|
|
Change in Salivary Cortisol Levels
Pre-Intervention
|
0.07 ug/dl
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: Pre-Intervention (Baseline), Post-Intervention (Week 6)Population: 20 rural teachers in a southwestern Montana school district
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. Lower scores indicate a better outcome.
Outcome measures
| Measure |
Experimental Group Yoga
n=20 Participants
20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session
|
|---|---|
|
Patient Health Questionnaire (PHQ-9)
Pre-Intervention
|
8.75 score on a scale
Standard Deviation 5.674
|
|
Patient Health Questionnaire (PHQ-9)
Post-Intervention
|
4.85 score on a scale
Standard Deviation 3.977
|
PRIMARY outcome
Timeframe: Pre-Intervention (Baseline), Post-Intervention (Week 6)Population: 20 rural teachers in a southwestern Montana school district
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. Lower scores indicate a better outcome.
Outcome measures
| Measure |
Experimental Group Yoga
n=20 Participants
20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session
|
|---|---|
|
Generalized Anxiety Disorder-7 Anxiety Scale (GAD-7)
Pre-Intervention
|
13.9 score on a scale
Standard Deviation 6.632
|
|
Generalized Anxiety Disorder-7 Anxiety Scale (GAD-7)
Post Intervention
|
4.85 score on a scale
Standard Deviation 3.99
|
PRIMARY outcome
Timeframe: Pre-Intervention (Baseline), Post-Intervention (Week 6)Population: 20 rural teachers in a southwestern Montana school district
Participants enrolled will have their heart rate data measured by the HeartMath Institute Inner Balance Bluetooth Sensor and accompanying software for Android or IOS smartphones (Inner Balance) or Inner Balance USB Sensor and accompanying computer software (EmWave Pro Plus (28, 29) The small plastic sensors will clip to the participant's earlobe and send photoplethysmography-derived (PPG) pulse signals via a non-invasive light source and photodetector.
Outcome measures
| Measure |
Experimental Group Yoga
n=20 Participants
20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session
|
|---|---|
|
Heart Rate Variability
Pre-Intervention
|
1.45 beats per minute (bpm)
Standard Deviation 0.62
|
|
Heart Rate Variability
Post-intervention
|
1.45 beats per minute (bpm)
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline), Post-Intervention (Week 6)Population: 20 rural teachers in a southwestern Montana school district
The Connor Davidson Resilience Scale (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 value is a 0 and the maximum value is a 100. A higher score indicates higher resilience, which indicates a better outcome.
Outcome measures
| Measure |
Experimental Group Yoga
n=20 Participants
20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session
|
|---|---|
|
Connor-Davidson Resilience Scale (CD-RISC)
Post-intervention
|
38.5 score on a scale
Standard Deviation 7.119
|
|
Connor-Davidson Resilience Scale (CD-RISC)
Pre-Intervention
|
28.35 score on a scale
Standard Deviation 6.002
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline), Post-Intervention (Week 6)Population: 20 rural teachers in a southwestern Montana school district
The Professional Quality of Life Index (Pro-QOL) is 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). The minimum score for each subscale is a 10, and the maximum score for each subscale is a 50. Higher scores on compassion satisfaction items indicate higher levels of job enjoyment, whereas higher scores on burnout and secondary trauma items indicate lower levels of job satisfaction. For each of the sub-scales scores are categorized as Low (22 or less), Moderate (between 23 and 41) or High (42 or more). A total sum of each sub-scale is not intended to be measured. Higher scores on the compassion satisfaction scale indicate a better outcome. Lower scores on burnout and secondary trauma indicate a better outcome.
Outcome measures
| Measure |
Experimental Group Yoga
n=20 Participants
20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session
|
|---|---|
|
Professional Quality of Life Index (Pro-QOL)
Pre-Intervention Burnout
|
34.4 score on a scale
Standard Deviation 4.43
|
|
Professional Quality of Life Index (Pro-QOL)
Post-Intervention Burnout
|
23.2 score on a scale
Standard Deviation 7.324
|
|
Professional Quality of Life Index (Pro-QOL)
Pre-Intervention Compassion Satisfaction
|
37.95 score on a scale
Standard Deviation 7.437
|
|
Professional Quality of Life Index (Pro-QOL)
Post-Intervention Compassion Satisfaction
|
39.2 score on a scale
Standard Deviation 6.55
|
|
Professional Quality of Life Index (Pro-QOL)
Pre-Intervention Secondary Traumatic Stress
|
23.9 score on a scale
Standard Deviation 8.723
|
|
Professional Quality of Life Index (Pro-QOL)
Post-Intervention Secondary Traumatic Stress
|
22.55 score on a scale
Standard Deviation 6.411
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline), Post-Intervention (Week 6)Population: 20 rural teachers in a southwestern Montana school district
The Teachers' Sense of Self-Efficacy is a 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 1 (nothing) to 9 (a great deal). Higher scores indicate higher self-perceptions of self-efficacy. Higher scores indicate a better outcome. A minimum score isa 12, and a maximum score of 108 is possible on the scale.
Outcome measures
| Measure |
Experimental Group Yoga
n=20 Participants
20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session
|
|---|---|
|
Teachers' Sense of Self-Efficacy (Short Form) (TSSE)
Pre-Intervention
|
74.85 score on a scale
Standard Deviation 20.306
|
|
Teachers' Sense of Self-Efficacy (Short Form) (TSSE)
Post-Intervention
|
82.3 score on a scale
Standard Deviation 8.694
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline), Post-Intervention (Week 6)Population: 20 rural teachers in a southwestern Montana school district
The PROMIS Sleep Disturbance Scale is 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). Higher scores indicate a greater severity of sleep disturbance. The scale's minimum score is an 8, and the scale's maximum score is 40; therefore, lower scores indicate better quality of sleep. Lower scores indicate a better outcome.
Outcome measures
| Measure |
Experimental Group Yoga
n=20 Participants
20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session
|
|---|---|
|
PROMIS Sleep Disturbance Scales (PROMIS)
Pre-Intervention
|
23.4 score on a scale
Standard Deviation 2.817
|
|
PROMIS Sleep Disturbance Scales (PROMIS)
Post-Intervention
|
20.1 score on a scale
Standard Deviation 6.456
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline), Post-Intervention (Week 6)Population: 20 rural teachers in a southwestern Montana school district
The PTSD Checklist for DSM-5 (PCL-5) is a 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). Higher scores indicate higher levels of traumatic stress in respondents. The scale's minimum score is a zero with a maximum score being an 80. Therefore, lower scores indicate an improvement in traumatic stress symptomology. Lower scores indicate a better outcome.
Outcome measures
| Measure |
Experimental Group Yoga
n=20 Participants
20 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Trauma-Informed Yoga: 6 weeks of twice weekly trauma-informed yoga for 45 minutes per session
|
|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
Pre-Intervention
|
26 score on a scale
Standard Deviation 20.736
|
|
PTSD Checklist for DSM-5 (PCL-5)
Post-Intervention
|
14.75 score on a scale
Standard Deviation 13.436
|
Adverse Events
Experimental Group Yoga
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place