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Depression, AnxietyNCT05085392

A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana

A study testing Trauma-Informed Yoga in people with Depression, Anxiety and Stress, run by Montana State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Depression, Anxiety, Stress
What is being tested?
Trauma-Informed Yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
24 Jan 2022to 8 Mar 2022
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 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Park High School

    Livingston, Montana, 59047

Other trials in United States

About this study

"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.

Read the detailed description

Project 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 goal of this study is to promote student health by supporting teacher wellbeing through a remotely-delivered trauma-informed yoga intervention.

Specific Aim: Expansion of previous pilot study to teachers in the southwestern Montana school district.

Methods: To explore scalability to rural communities without access to yoga instructors, we will implement a limited feasibility study of online yoga delivery to classroom teachers. This study will enroll a minimum 30 Livingston teachers (taught trauma-informed yoga via Zoom), twice weekly for 45-minute trauma-informed yoga sessions during the 6-week intervention period. No participants were assigned to the "No Intervention" arm. To measure physical health outcomes, pre, mid-, and post-intervention cortisol testing will be utilized to evaluate any changes in teacher stress levels before and after the program. Heart rate variability will also be assessed for teachers pre, mid-, and post-intervention using the HeartMath Inner Balance PPG sensor and Em Wave Pro Plus software. To assess behavioral health, pre- and post-survey instruments will collect targeted wellness/mental health data from teachers. An Adverse Childhood Experience Self-Reporting Screener will also be given to participants to establish a baseline of exposure to childhood trauma, which is closely correlated with health outcomes. Teachers will also complete the Teachers' Sense of Self Efficacy Survey and the Professional Quality of Life Index, which are linked to teacher mental health, retention, and career satisfaction.

Being tested
Trauma-Informed Yoga
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma-Informed YogaBehavioural

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

Study groups in NCT05085392
Study groupRoleWhat they receive
Experimental Group YogaExperimental35 rural teachers in a southwestern Montana school district participating in a trauma-informed yoga intervention
Receives: Behavioral: Trauma-Informed Yoga
No InterventionNo interventionNo participants were assigned to the No Intervention Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes (5)

  1. Connor-Davidson Resilience Scale (CD-RISC)

    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.

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

  2. Professional Quality of Life Index (Pro-QOL)

    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.

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

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

    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.

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

  4. PROMIS Sleep Disturbance Scales (PROMIS)

    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.

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

  5. PTSD Checklist for DSM-5 (PCL-5)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2021
  2. Study start24 Jan 2022
  3. Primary completion8 Mar 2022
  4. Study completion8 Mar 2022

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05085392
Sponsor's protocol ID
MontanaSUYear3
Other IDs
P20GM104417
Status last verified
Jun 2023
First submitted
7 Oct 2021
Last updated
5 Jul 2023
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Trauma-Informed Yoga in people with Depression, Anxiety and Stress, 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 1 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 5 Jul 2023. 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 29 Jun 2023). 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?

Change in Salivary Cortisol Levels (time frame: Pre-Intervention (Baseline), Post-Intervention (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?

On the ClinicalTrials.gov record for NCT05085392.

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 5 Jul 2023.

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Clinical Trial NCT05085392 | AzTrials