Trauma and Stressor Related DisordersNCT05844007
A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana Year 2
A study testing Trauma-Informed Yoga in people with Trauma and Stressor Related Disorders, run by Montana State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma and Stressor Related Disorders
- What is being tested?
- Trauma-Informed Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2023to 8 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any students that are not enrolled in pre-selected PE classes at Park or Gardiner High Schools in Southwest Montana
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana
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.
Read the 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.
- Conditions
- Trauma and Stressor Related Disorders
- Being tested
- Trauma-Informed Yoga
- Medical subject headings
- Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Informed YogaBehavioural
Trauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions
| Study group | Role | What they receive |
|---|---|---|
| High School Students: Remote Delivery | Experimental | Remote delivery of trauma-informed yoga session for high school students Receives: Behavioral: Trauma-Informed Yoga |
| High School Students: Face-to-Face Delivery | Experimental | Face-to-face delivery of trauma-informed yoga session for high school students Receives: Behavioral: Trauma-Informed Yoga |
| Teachers: Remote Delivery | Experimental | Remote delivery of trauma-informed yoga session for teachers Receives: Behavioral: Trauma-Informed Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre-Intervention, first day of Week 1 and post-intervention, last day of Week 6
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.
Measured: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
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.
Measured: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
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.
Measured: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Secondary outcomes (5)
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).
Measured: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
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.
Measured: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
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.
Measured: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
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.
Measured: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
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.
Measured: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start13 Jan 2023
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trauma and Stressor Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Lauren Davis, Montana State University
- Investigators
- Alexandra Adams, MD, Ph.D, Study director, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844007
- Sponsor's protocol ID
- MontanaSUYear4
- Other IDs
- 5P20GM104417
- Status last verified
- Mar 2024
- First submitted
- 24 Apr 2023
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana
- ClinicalTrials.gov ID
- NCT05844007
- Acronym / sponsor ID
- MontanaSUYear4
- Conditions
- Trauma and Stressor Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Posted 26 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High School Students: Remote Delivery | Experimental | Behavioral: Trauma-Informed YogaRemote delivery of trauma-informed yoga session for high school students |
| High School Students: Face-to-Face Delivery | Experimental | Behavioral: Trauma-Informed YogaFace-to-face delivery of trauma-informed yoga session for high school students |
| Teachers: Remote Delivery | Experimental | Behavioral: Trauma-Informed YogaRemote delivery of trauma-informed yoga session for teachers |
Who may qualify
- Ages
- 13 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Any students that are not enrolled in pre-selected PE classes at Park or Gardiner High Schools in Southwest Montana
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma-Informed YogaTrauma-informed yoga intervention, delivered either in-person or remotely for 6 weeks, twice weekly for 45 minutes sessions | Behavioural | High School Students: Face-to-Face Delivery, High School Students: Remote Delivery, Teachers: Remote Delivery |
Primary outcome
Salivary Cortisol Levels
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Professional Quality of Life Index (Pro-QOL)
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Teachers' Sense of Self-Efficacy (Short Form)
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
PROMIS Sleep Disturbance Scales
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Pre-Intervention: First day of Week 1 and Post-Intervention, last day of Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Adams, MD, Ph.D study director
Montana State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Informed Yoga in people with Trauma and Stressor Related Disorders, run by Montana State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Cortisol Levels (time frame: Pre-Intervention, first day of Week 1 and post-intervention, last day of Week 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.