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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Pre-Intervention (Baseline), Post-Intervention (Week 6)

Results posted on

2023-07-05

Participant Flow

Participant milestones

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

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

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

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

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

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

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

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

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

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

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 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. Lauren Davis

Montana State University

Phone: 8287736328

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place