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NCT04664855

A Trauma-Informed Approach for Positive Youth Development for Montana Students

Completed NA Results posted Last updated 15 November 2021
What this trial tests

NA trial testing Trauma-Informed Yoga in Depression, Anxiety in 47 participants. Completed in 5 March 2021.

Timeline
15 January 2021
Primary endpoint
5 March 2021
5 March 2021

Quick facts

Lead sponsorMontana State University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment47
Start date15 January 2021
Primary completion5 March 2021
Estimated completion5 March 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Montana State University

Who can join

Adults 14 to 19, any sex, with Depression, Anxiety or Suicidal Ideation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Salivary Cortisol Levels Primary · Week 1 and. Week 6

Students 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 changed cortisol levels. A biostatistician will provide analysis and conclusion of these samples at the conclusion of the study; the mean change pre vs. post is provided here. Negative change indicates improvement in stress levels.

GroupValue95% CI
Experimental Yoga Group-0.26± .12
Control Group (No Yoga Intervention)-0.17± .27
Patient Health Questionnaire for Adolescents Secondary · Baseline and 6 weeks

This 9 item questionnaire is designed to evaluate severity of depressive symptoms in adolescents. 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 negative change in score from pre- to post-assessment indicates an improvement in symptomology. Pre and post-intervention means are reported here.

Baseline Mean
GroupValue95% CI
Experimental Yoga Group8.00± 6.75
Control Group (No Yoga Intervention)5.36± 4.89
Post-Intervention Mean
GroupValue95% CI
Experimental Yoga Group6.39± 6.73
Control Group (No Yoga Intervention)4.18± 5.24
Generalized Anxiety Disorder-7 Anxiety Scale Secondary · Baseline and 6 weeks

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 negative change in score from pre- to post-assessment indicates an improvement in symptomology. Pre and post-intervention means are reported here.

Pre-Intervention Mean
GroupValue95% CI
Experimental Yoga Group6.83± 5.25
Control Group (No Yoga Intervention)5.27± 5.13
Post-Intervention Mean
GroupValue95% CI
Experimental Yoga Group5.35± 5.97
Control Group (No Yoga Intervention)4.55± 4.54
Connor-Davidson Resilience Scale (CD-RISC) Secondary · Baseline and 6 weeks

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. Possible scores range from 0-100. A higher score indicates higher resilience. Pre and post-intervention means are reported here.

Pre-intervention mean
GroupValue95% CI
Experimental Yoga Group25.39± 7.45
Control Group (No Yoga Intervention)28.32± 7.11
Post-Intervention Mean
GroupValue95% CI
Experimental Yoga Group24.87± 9.71
Control Group (No Yoga Intervention)30.45± 6.44

Sponsor's own description

Given the prevalence of suicide and mental health issues in rural Montana, this project is intended to help mitigate stressors that may contribute to poor behavioral and mental health in high school-aged children. The immediate goal is to measure physical and mental health outcomes in adolescents resulting from a trauma-informed yoga intervention designed to foster positive youth development and student success. It builds on feasibility study for year one in which 19 experimental condition participants engaged in an 8-week yoga program.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Mitigating Rural Adolescent Trauma: Remote Delivery of a Trauma-Informed Yoga Intervention During COVID-19.
    Davis L, Aylward A. · · 2022 · cited 5× · PMID 36471891 · DOI 10.1007/s40653-022-00496-9

Verify or expand the search:

Other trials of Trauma-Informed Yoga

Trials testing the same drug.

Other recruiting trials for Depression, Anxiety

Currently open trials in the same condition.

Other Montana State University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04664855.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing