NCT05085392

Brief Summary

"A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana" is intended to help mitigate stressors that may contribute to poor behavioral and mental health in rural Montana teachers. The immediate goals of this study is to promote student health by supporting teacher wellbeing through a remotely-delivered trauma-informed yoga intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 29, 2023

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

October 7, 2021

Results QC Date

April 19, 2023

Last Update Submit

June 30, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in 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, 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

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

  • Patient Health Questionnaire (PHQ-9)

    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.

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

  • Generalized Anxiety Disorder-7 Anxiety Scale (GAD-7)

    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.

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

  • Heart Rate Variability

    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.

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

Secondary Outcomes (5)

  • Connor-Davidson Resilience Scale (CD-RISC)

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

  • Professional Quality of Life Index (Pro-QOL)

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

  • Teachers' Sense of Self-Efficacy (Short Form) (TSSE)

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

  • PROMIS Sleep Disturbance Scales (PROMIS)

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

  • PTSD Checklist for DSM-5 (PCL-5)

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

Study Arms (2)

Experimental Group Yoga

EXPERIMENTAL

35 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention

Behavioral: Trauma-Informed Yoga

No Intervention

NO INTERVENTION

No participants were assigned to the No Intervention Arm

Interventions

6 weeks of twice weekly trauma-informed yoga for 45 minutes per session

Experimental Group Yoga

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any teacher currently employed by the Livingston school district who wishes to participate in the intervention (up to 35 participants)

You may not qualify if:

  • Only teachers will be considered for this study (i.e., no school staff, administrators, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Park High School

Livingston, Montana, 59047, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Results Point of Contact

Title
Dr. Lauren Davis
Organization
Montana State University

Study Officials

  • Alexandra Adams, MD, Ph.D

    Montana State University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Curriculum & Instruction

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 20, 2021

Study Start

January 24, 2022

Primary Completion

March 8, 2022

Study Completion

March 8, 2022

Last Updated

July 5, 2023

Results First Posted

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations