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RecruitingNCT07934082TAY-ADOUpdated Nov 12, 2026

Trauma Adapted Yoga for Adolescents and Young Adults in Psychiatric Outpatient Treatment

An interventional study of Trauma Adapted Yoga and Physical Activity Control in Psychiatric Disorders and Emotional Dysregulation, sponsored by State University of New York - Upstate Medical University. Recruiting at 1 site in United States. Open to participants aged 12 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by State University of New York - Upstate Medical University · Not applicable, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
143
Allocation
Randomized
Ages
12 Years to 29 Years
Sex
All
01

Study summary

Improving emotional well-being (EWB) is a national research priority given its central role in resilience, functioning, and long-term health. Mechanisms of developing EWB in adolescents are not well understood, particularly in those with psychiatric disorders and emotional dysregulation (ED), a transdiagnostic construct that may underlie multiple psychiatric disorders, with significant and potentially life-threatening sequelae if untreated. Integrative treatment options are critical to reach more youth at-risk of ED and to support youth EWB in this at-risk population.

Trauma Adapted Yoga (TAY) is a protocolized integrative intervention tailored for youth with psychiatric conditions - a population with high rates of trauma exposure - and is designed to target critical elements of EWB including emotional valence, qualify of life, self-efficacy, and life satisfaction, as well as improving emotion regulation (ER) and interoceptive awareness (IA), two mechanistic pathways that can be targeted in treatment.

The overall goal of this project is to use a randomized control trial (RCT) to evaluate the effectiveness of TAY for adolescents and young adults with psychiatric disorders as well as understand psychological and biological mechanisms. We hypothesize that TAY will improve psychiatric symptoms through improving ER and IA. We also examine biologic markers of stress and emotion response through epigenetic and heart rate variability changes. Given the high sensitivity of DNA methylation (DNAm) to various environmental influences, connections to neuroendocrine function, and its role in reflecting how a person's exposure to certain therapies is incorporated biologically, it serves as an excellent and novel candidate to explore.

We target adolescents and young adults in psychiatric treatment within the last 6 months and randomize them into the following arms 1) TAY and 2) physical control arm. We hypothesize that adolescents and young adults in the TAY enhanced care arm will have improved EWB via improvements in ED and IA and that outcomes may be moderated by age, trauma exposure, severity of ED and type of treatment. The potential to improve psychopathology utilizing TAY in vulnerable adolescents is significantly important to public health.

Specific Aims:

Aim 1. Feasibility and acceptability: Demonstrate the feasibility of recruiting, retaining, and delivering a 6-week TAY group intervention to adolescents and young adults with psychiatric disorders in psychiatric care within the last 6 months. We hypothesize that TAY will be uniquely appealing to and positively received by this vulnerable population and that 80% retention will be achieved.

Aim 2. Psychiatric symptom outcomes: Evaluate the effectiveness of 6-week twice weekly TAY on psychiatric symptoms in adolescents and young adults with psychiatric disorders using a physical exercise control arm cross-over design. We hypothesize that participating in the intervention group will:

Reduce participants' reported trauma symptoms ( CPSS V), internalizing (anxiety and depression measured on the BSI, negative affect measured on PANAS), and externalizing (hostility measured on the BSI, attention/impulsivity/opposition measured on the SNAP IV) symptoms.

Aim 3. Emotional well-being and physiological outcomes: Evaluate improvements in EWB via pre/post self-report measures (such as Emotional valence via PANAS-X) real-time Fitbit monitoring of emotions and emotional intensity twice weekly, ongoing physiologic data utilizing Fitbit (resting HR, HRV, sleep quality), patients' self-reported resilience, emotional control, bodily awareness (IA).

Aim 4. DNAm changes: Utilize exploratory discovery DMR (differentially methylated regions) and inflammation targeted gene investigation. Specifically, we aim to explore the association between targeted CpG sites known to play a role in regulating the HPA-axis activity and emotional response to stressful situations with the intervention type and regulatory outcomes. We will use EWAS to discover DMS within promoter regions of NR3C1, CRH, and FKBP5 because they have already been shown to play a key role in stress regulation.

Aim 5. DNAm-outcome associations: Utilizing matched biological and clinical data, determine how pre-post changes in DNA methylation are related to pre-post changes in interoception, heart rate variability, and emotion regulation. Our study will determine whether differences exist between DNAm change from baseline to post-intervention among individuals who underwent TAY and the other group who were exposed to the physical activity condition. Furthermore, our study will determine whether there is an association between DNAm changes at the identified targeted inflammation CpG sites and DMRs and changes in interoception, heart rate variability (HRV), and emotion regulation.

Read the detailed description

Introduction

Since the emergence of the COVID-19 pandemic, youth mental health has faced a persistent crisis, further widening the existing gaps (Brown \& Carrington, 2025; Zhang-James, et al 2025). Less than half of youth diagnosed with a psychiatric disorder are estimated to receive treatment (Clinical Update, 2023). The consequences of unmet needs include disruptive behaviors, suicide attempts, challenges with transitioning into adulthood (Heinrich et al., 2023) and risk of chronic illness that are a major cause of morbidity and economic burden and threaten emotional well-being (Schlack, 2021).. Integrative modalities that can be replicated and provided at low cost in group settings are needed with rigorous research to investigate mechanisms of emotional wellbeing for adolescents and young adults, particularly those with psychiatric conditions.

Emotional wellbeing (EWB) is an important public health research priority given its central role in resilience, functioning, and long-term health as well as its association with psychiatric disorders. A multi-dimensional construct, EWB includes emotional valence, reflective features about satisfaction and sense of meaning, and requires multi-faceted innovative techniques to further understanding, particularly among adolescents given that EWB and emotion regulation (ER) are in development. Indeed, ER is a central task of adolescents and young adults and defined "the ability to modify the onset, intensity, duration, and type of emotional response to a situation" and is associated with psychological constructs of emotion reactivity, cognitive appraisal and rumination, as well as physiologic mechanisms of inflammation, stress and HPA axis pathways involved in vasopulmonary constriction.

Adolescents and young adults with psychiatric conditions face multiple challenges to achieving EWB given chronic conditions with high stress and inflammation. Emotion dysregulation is a transdiagnostic construct that is thought to underlie multiple psychiatric disorders and beginning to be understood in terms of physiologic mechanisms such as the links between ED, inflammation, and childhood adversity. It is hypothesized that many adolescents and young adults with psychiatric conditions have high rates of both inflammatory processes and childhood adversity.

While the bulk of evidence for yoga in general and in clinical populations has focused on adults, there is emerging evidence that yoga is feasible, acceptable, and can promote emotional wellbeing for adolescents and young adults. A recent review of yoga practice among youth supports a variety of biological benefits to the sympathetic nervous system, decreased stress, improvements of psychiatric symptoms and improvements to interoceptive awareness, mindfulness, and overall wellbeing, as and outcomes such as improved wellbeing (Kerekes et al., 2026).

Trauma sensitive yoga has been developed for use with populations who may have experienced traumatic events and includes methods to help ensure psychological safety such as for individuals with psychiatric diagnosis and potential trauma histories. Protocols emphasize safe movement, choice, and connection to bodily sensations. Trauma Adapted Yoga is a specific type of trauma sensitive yoga developed by Josefin Wilkstrom and Nora Kerekes for use in psychiatric and medical populations with high prevalence of trauma and nervous system dysregulation. Prior research supports its role in reducing perceived stress, aggression, and self-harm in institutionalized youth. These protocols also emphasize mindfulness, interoception, breathing, and moments of stillness that activate the parasympathetic nervous system, which in essence counters the effects of stress and anxiety on the body.

A previous pilot study by our team demonstrated the feasibility of Trauma Adapted Yoga (TAY) intervention in adolescents participating in psychiatric care on inpatient units. Most adolescents participated in the yoga intervention and found subjective benefit to stress and anxiety (Khoury et al., 2024) as well as demonstrated significant improvement in psychiatric symptoms over the course of their hospitalization (Chung et al., 2026).. Additionally, a preliminary pilot of adolescents in outpatient psychiatric care found improvement in symptoms of stress and anxiety, self-reported resilience and interoceptive awareness as measured by the MAIA-2. Specifically, our pilot data of 10 adolescent participants who completed pre and post assessments demonstrated increased interoceptive awareness, modest resilience gains and symptom reduction across psychiatric symptoms such as PTSD, emotional pain and ADHD. This is consistent with previous research which has implicated interoceptive awareness as one potential mechanism for improvement in PTSD for individuals with trauma (Neukirch et al., 2019)..

Mechanisms of yoga to support wellbeing overall is multifaceted and includes both bottom-up and top-down processes. A model by Gard and colleagues Gard and colleagues (2014) outlines multiple mechanisms by which yoga supports psychological wellbeing. See figure below.

A previous pilot study by our team demonstrated the feasibility of Trauma Adapted Yoga (TAY) intervention in adolescents participating in psychiatric care on inpatient units. Most adolescents participated in the yoga intervention and found subjective benefit to stress and anxiety (Khoury et al., 2024) as well as demonstrated significant improvement in psychiatric symptoms over the course of their hospitalization (Chung et al., 2026).. Additionally, a preliminary pilot of adolescents in outpatient psychiatric care found improvement in symptoms of stress and anxiety, self-reported resilience and interoceptive awareness as measured by the MAIA-2. Specifically, our pilot data of 10 adolescent participants who completed pre and post assessments demonstrated increased interoceptive awareness, modest resilience gains and symptom reduction across psychiatric symptoms such as PTSD, emotional pain and ADHD. This is consistent with previous research which has implicated interoceptive awareness as one potential mechanism for improvement in PTSD for individuals with trauma (Neukirch et al., 2019)..

Mechanisms of yoga to support wellbeing overall is multifaceted and includes both bottom-up and top-down processes. A model by Gard and colleagues Gard and colleagues (2014) outlines multiple mechanisms by which yoga supports psychological wellbeing. See figure below.

A previous pilot study by our team demonstrated the feasibility of Trauma Adapted Yoga (TAY) intervention in adolescents participating in psychiatric care on inpatient units. Most adolescents participated in the yoga intervention and found subjective benefit to stress and anxiety (Khoury et al., 2024) as well as demonstrated significant improvement in psychiatric symptoms over the course of their hospitalization (Chung et al., 2026).. Additionally, a preliminary pilot of adolescents in outpatient psychiatric care found improvement in symptoms of stress and anxiety, self-reported resilience and interoceptive awareness as measured by the MAIA-2. Specifically, our pilot data of 10 adolescent participants who completed pre and post assessments demonstrated increased interoceptive awareness, modest resilience gains and symptom reduction across psychiatric symptoms such as PTSD, emotional pain and ADHD. This is consistent with previous research which has implicated interoceptive awareness as one potential mechanism for improvement in PTSD for individuals with trauma (Neukirch et al., 2019)..

Inflammatory pathways and epigenetics.

Yoga has been demonstrated to be acceptable and effective in multiple populations including those with psychiatric conditions and there is growing evidence that yoga can decrease markers of stress and inflammation Estaveo, 2021). A recent systematic review of RCTs involving over 700 adults found that yoga consistently downregulates pro-inflammatory genes- interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), and nuclear factor kappa B (NF-kappB) in five studies and upregulated anti-inflammatory and immune regulatory genes-transforming growth factor-beta (TGF-beta), forkhead box P3 (FOXP3), soluble human leukocyte antigen G (sHLA-G) and IL-10- in four studies (Giridharan, 2025). Molecular changes have also been found enhancing expression of genes linked to DNA repair, mitochondrial function, and epigenetic regulation (reduced TNF methylation and increased microRNA-133B) that correlate with clinical benefits such as reduced disease activity in rheumatoid arthritis (RA), improved glycemic control in type 2 diabetes and improved quality of life among breast cancer survivors.

Previous studies suggest that yoga has been proven to be beneficial in regard to enhancing immunity and supporting the management of chronic diseases such as cardiovascular, respiratory, endocrine disorders, obesity, cancer, and metabolic syndrome (Madan et al., 2022). In adults with depression, yoga has been shown to improve depression as well as increase BDNF, a marker of neural plasticity, and reduce serum cortisol (Naveen et al., 2016).. A recent systematic review highlights the evidence that yoga can improve blood pressure, cortisol and cytokine levels including IL-6, TNF-α and IL-1β providing support to the hypothesis that yoga can positively influence the immune response by stress regulation (Estaveo, 2022).. Biomarkers involved in the inflammatory process have been seen to be changed in the short term and longer term, which are promising. Additionally, yoga has been shown to increase salivary IgA in pregnant women after yoga with sustained results that also predicted improved birth outcomes (Chen et al., 2017).

Indeed, yoga practice has been shown to promote hormone regulation, autonomic nervous system regulation, physical health, as well as metabolism, circulation, oxidative stress, and inflammation (McCall, 2013). Less is known about these mechanisms in adolescents and young adults. Childhood inflammation has nevertheless been shown to be a risk factor in the development of mental and cardiometabolic disorders in early adulthood (Palmer, 2024). Elevated levels of inflammatory markers were consistently associated with an increased risk of suicidal behavior across diverse populations, and preliminary evidence suggests anti-inflammatory interventions may reduce suicidality (Baldini, 2025). Further, a meta-analysis of 22 studies (n=20,791) found a positive association between depression and concurrent and future inflammation for children and adolescents (Colasanto, 2020).. In addition, sex-based differences found in inflammatory-related pathways involved in the production of cytokines and in interferon and complement signaling as associations found for only adolescent females with depression Zonca, 2024).

In terms of measurement, previous studies have demonstrated that salivary enzymes can decrease immediately after or within 30-60 minutes after a yoga session (Ali \&Neter, 2022) . Patients with high inflammation at baseline may benefit more from this type of intervention and certain patients with psychiatric illness are found to have markers of high inflammatory states, such as patients with mood disorders, anxiety and PTSD as well as sleep disorders, which are highly associated with psychiatric disorders and functional impairment.

An emerging and innovative area in yoga research involves epigenetics and gene expression modification (Giridharan, 2023).. An RCT with psychologically stressed women demonstrated reduced DNA methylation in the genes associated with IL-6, TNF in the yoga group (Harkess 2016. Studies with adult veterans with PTSD have demonstrated that DNA methylation and markers of epigenetics can change post mindfulness or yoga interventions (Bishop, 2018).. Additionally, decreases in DNA methylation of TNF region found in women participating in a bi-weekly yoga intervention for 8 weeks (Harkess et al., 2016).. Bishop and colleagues demonstrated that FKBP5 methylation may be modified by non-pharmacological interventions and that regulatory regions thought to represent relatively stable methylated regions are in fact malleable through therapies that may help patients regulate stress feedback32. Current evidence supports the potential impact of mindfulness-related interventions such as yoga on the regulation of FKBP5 to feedback on glucocorticoid hyperactivity to reduce stress. Other implicated epigenetic markers include CRH and NR3C1 methylation levels, as this has been investigated as potential biomarkers for determining the success of psychological therapies, for example, in adults with severe PTSD (Lewis et al., 2023; Wilker et al., 2023).. The potential to change epigenetics through alternations in DNA sequencing is promising in its ability to modify disease onset and progression for vulnerable populations, as well as to improve wellbeing for subsequent generations.

Interoception

Interoception has been implicated in a variety of psychiatric disorders with interoceptive dysregulation being associated with depressive disorders, anxiety disorders, substances, and eating disorders (Khoury et al., 2019).. Interoception and inflammation may be associated in that chronic inflammation may distort internal body-state representation that interferes with interoceptive regulation and activates immune pathways (Zheng et al, 2021).. Nord \& Garfinkel support the notion that interoceptive circuits may offer new targets for mind-body interventions by bridging peripheral inflammation and psychiatric symptoms37. Nevertheless, Eggart and colleagues investigated the association between self-report interoceptive awareness and CRP in individuals with Major Depressive Disorder and did not find correlation (Eggart and colleagues). But depressed patients with raised CRP have demonstrated functional connectivity impairment in ventral striatum and medial prefrontal reward and motivation processing areas. Mixed results thus far warrant further exploration.

It may be that yoga acts on interoception and inflammation through different physiologic pathways given some studies showing independence (Eggart et al., 2023; Feldman eta l., 2023). Both improved interoceptive awareness and decreased inflammation can improve whole body health. This study utilizes an adapted yoga intervention to examine changes in inflammatory pathways and epigenetics that have been implicated in trauma (primary outcome), as well as psychiatric symptoms, interoceptive awareness, resilience and whole-body health (secondary outcome) in vulnerable populations, adolescents and young adults with psychiatric conditions.

Despite the widespread interest in yoga among adolescents and young adults and the research demonstrating improved wellbeing for healthy youth, there is a dearth of research studying the mechanisms of yoga for adolescents and young adults with psychiatric conditions. Additionally, systematic exploration of mechanisms of inflammation and epigenetics in rigorous controlled trials is lacking. This is important to understand mechanisms to support emotional wellbeing for this at-risk population whose psychiatric conditions put them at greater risk for negative outcomes, including chronic illness. Larger sample-sized randomized controlled trials with longer term follow up are needed to identify optimal treatment regimens with more representative and appropriately powered samples (Estaveo, 2022).. In addition, a yoga protocol that has been utilized in research studies previously and can be replicated and taught to clinical providers is critical to advance understanding of what kind of yoga may be useful for which populations.

Study Goals and Objectives

Based on the existing evidence, we hypothesize that TAY will improve emotional wellbeing for adolescents and young adults primarily through emotion and stress regulation, although the pathways may involve more top-down processing for young adults and bottom-up processing for adolescents as EWB evolves in development. Main pathways examined in this RCT include psychologic and physiologic mechanisms of stress and emotion regulation.

We hypothesize that TAY intervention will be feasible and accepted intervention given its flexibility and adaptability to unique needs of young adults with psychiatric illness. We believe the saliva swab noninvasive technique will be acceptable and feasible for young adults. We expect to see trends of improved resilience and emotional regulation and hypothesize that these mechanisms can improve psychiatric symptoms for those in intervention arm more than those in the control arm. Further, we hypothesize that 6-week twice weekly TAY will have benefits in psychiatric symptoms through improving emotion regulation and interoceptive awareness. Additionally, we hypothesize that epigenetic changes in HPA-axis and emotion response regulation may be appreciable post intervention.

Interventional Methods

Following consent and completion of the pre-intervention assessment, participants will be randomized using a computerized program to either TAY or a physical-activity control condition. TAY will be provided as a complementary intervention alongside usual outpatient or intensive outpatient care. Participants will attend closed-group, 60-minute sessions twice weekly for 6 weeks. Facilitators will be trained in human-subjects research and trauma-adapted yoga. Participants will be offered choices during the sessions and may decline any activity that causes discomfort.

Control participants will be asked to engage in physical activity of their choice twice weekly during the times scheduled for the yoga sessions, with Fitbit reminders. Weekly telephone calls will be used in both groups to support retention and provide reminders.

Assessments will be completed within 2 weeks before and after the intervention. Post-intervention procedures will include repeat questionnaires, saliva collection, chart-based measures, and a qualitative interview about the participant's experience. Participants on the control arm may elect to switch groups and complete an additional 6-week yoga period. Their pre- and post-intervention assessment will be collected for the cross-over TAY group, as permitted by the approved protocol. Any crossover, intervention changes, or deviations from the assigned condition will be documented and incorporated into the analysis. For the main study, the crossover policy should be finalized before registration and statistical analysis.

Data Management

Each participant will receive a unique study identification code. Identifying information and consent documents will be stored separately from research data in locked, access-restricted locations. The linkage file connecting participant names with study codes will be maintained separately and will be accessible only to the principal investigator and authorized study personnel.

Questionnaire, interview, chart-review, Fitbit, and saliva data will be coded with the study identification number. Paper records will be stored in locked research files, and electronic data will be maintained on password-protected institutional computers, secure institutional servers, Redcap, or approved Upstate OneDrive locations. Research staff with required human-subjects training will have access only to the de-identified data necessary for their responsibilities.

Fitbit data will be retrieved through the authorized Google Health API connection using encrypted HTTPS and OAuth 2.0 procedures. Saliva specimens will be labeled only with study codes and shipped to TruDiagnostics for DNA-methylation analysis. Raw and processed methylation files will be stored on password-protected, encrypted institutional systems.

The principal investigator will oversee data transmission. Any shared data will be de-identified, encrypted, and limited to authorized collaborators identified in the consent materials. Individual saliva or incidental genetic results will not be returned to participants, family members, or treating clinicians. Study data will be retained for at least 10 years.

Data Analysis

Demographic and clinical characteristics will be summarized using descriptive statistics, including means, medians or modes, ranges, and frequencies, as appropriate. Feasibility outcomes will include eligibility and enrollment, retention, completion of assessments, intervention participation, and completion of saliva and Fitbit procedures.

Continuous psychological, physical-health, HRV, and biological measures will be summarized at baseline and post-intervention. Pre-to-post changes within each group and exploratory differences between groups will be examined using t-tests or nonparametric alternatives when distributional assumptions are not met. Results will emphasize estimated changes, effect sizes, confidence intervals, and descriptive feasibility findings rather than definitive claims of effectiveness.

Qualitative interviews will be reviewed using thematic analysis to identify participants' and staff members' experiences of the yoga intervention, barriers to participation, perceived benefits, and recommendations for future implementation. Missing assessments, withdrawals, intervention switching, and protocol deviations will be reported by group. No imputation will be performed unless specified in a subsequently approved analysis plan.

02

Conditions studied

  • Psychiatric Disorders
  • Emotional Dysregulation

Keywords

  • Trauma Adapted Yoga
  • TAY
  • Interoceptive awareness
  • Emotion regulation
03

In context

Mental Disorders

1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.

This study's planned enrollment of 143 is above the median of 100 across 1,301 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

State University of New York - Upstate Medical University is the lead sponsor of 158 studies on the registry; 19 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

In psychiatric care defined as in therapy or medication management or both in intensive outpatient, general outpatient or integrated care behavioral health being seen by psychiatric providers (therapists, psychiatrists, psychiatric nurse practitioners) within Upstate Medical University.

Exclusion criteria

Exclusion Criteria:

Individuals who have serious physical illness that would prohibit participation in any physical activity Individuals who cannot read and understand at least one of the following languages: English (due to measures given and researcher limitations).

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
143 participants (estimated)

Study arms

  • Active comparator
    Physical Activity

    Participants will be reminded twice weekly at same time as intervention to conduct physical activity on their own

    Behavioral: Physical Activity Control

  • Experimental
    Trauma Adapted Yoga

    Participants will participate in twice weekly hour long yoga in a group setting for 6 weeks. The yoga protocol is designed to support nervous system regulation, help participants feel safe and empowered in their body and enhance interoception through specific language, sequencing and support.

    Behavioral: Trauma Adapted Yoga

Interventions

  • BehavioralTrauma Adapted Yoga

    Participants will participate in twice weekly hour long yoga in a group setting for 6 weeks. The yoga protocol is designed to support nervous system regulation, help participants feel safe and empowered in their body and enhance interoception through specific language, sequencing and support.

  • BehavioralPhysical Activity Control

    Participants will be reminded twice weekly at same time as TAY group to do physical activity of their choice on their own.

06

What researchers measure

Primary outcomes

  1. Positive Affect and Negative Affect-Extended.

    The Positive Affect and Negative Affect-Extended (PANAS-X) instrument consists of 30 items and captures the valence (positive and negative) and the arousal (activated or deactivated) of the mood descriptors (Watson \& Clark, 1994). As a result, PANAS-X30 makes it possible to measure positive (pleasant) and negative (unpleasant) and within both activated and deactivated affect states. This distinction is relevant in yoga studies, where effects are likely to be found in pleasant, deactivated emotions such as feeling calm, content, and relaxed. The following are examples for all four categories. Positive activated: active, enthusiastic, excited, inspired and, proud; Positive deactivated: at ease, serene, calm, relaxed, and content; Negative activated: afraid, scared, hostile, guilty, and ashamed; Negative deactivated: tired, sluggish, drowsy, dull, and bored (Watson \& Clark, 1994).

    Time frame: Within 2 weeks before starting intervention and within 2 weeks post intervention

  2. Multidimensional Assessment of Interoceptive Awareness (MAIA)

    The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report measure that assesses various dimensions of bodily awareness (Mehling, et. al., 2018). Respondents rate statements on a Likert scale, ranging from 0-1 (with 0 indicating "Never" and 5 indicating "Always"). Scores are totaled for each of 8 subscales that assess the respondents' tendency to notice, distract from, and worry about bodily sensations, maintain attention despite sensations, have awareness of connection between body and emotion, self-regulate, listen to the body for insight, and to trust ones' own body. Higher scores indicate more interoceptive awareness (Mehling, et. al., 2018).

    Time frame: Within 2 weeks before starting intervention and within 2 weeks post intervention

  3. Difficulties in Emotion Regulation Scale (DERS)

    The Difficulties in Emotion Regulation Scale (DERS) is a self-report measure that is well validated and frequently utilized for assessing emotion regulation deficits. This measure has good reliability and validity with adolescents and adults of all ages and has been validated internationally. This scale consists of six subscales, ranging from five to eight items each, with a total of 36 total items. Many of the items for the scales begin with "When I'm upset", and respondents are asked to respond with how often the items are applicable to themselves. Responses range from 1 to 5, where 1 = almost never, 2 = sometimes, 3 = about half the time, 4 = most of the time, and 5 = almost always (Kaufman et al., 2016).

    Time frame: Within 2 weeks before starting intervention and within 2 weeks post intervention

Secondary outcomes

  1. The PTSD Checklist for DSM-5 (PCL-5) for young adults

    The PTSD Checklist for DSM-5 (PCL-5) is a commonly used self-rated measure utilized to measure DSM-5 PTSD symptoms. This scale assesses symptoms across the four DSM-5 clusters: intrusions (Criterion B), avoidance of trauma reminders (Criterion C), negative alterations in cognitions and mood (Criterion D), and alterations in arousal and reactivity (Criterion E). This measure consists of 20 items with responses ranging from 0 to 4 with 0 = "not at all", 1 = "a little bit", 2 = "moderately", 3 = "quite a bit", to 4 = "extremely". The PCL-5 has been examined across several different languages and settings.

    Time frame: Within 2 weeks before starting intervention and within 2 weeks post intervention

  2. Heart Rate Variability

    Heart rate variability (HRV), or the beat-to-beat alteration in heart rate, offers a noninvasive indicator of the autonomic nervous system's activity. HRV has been used as a proxy for health and fitness and as an indicator of autonomic regulation. Low HRV-indicating reduced parasympathetic cardiac control-was associated with sleep problems and difficulty regulating emotions, while yoga practice was associated with increased HRV. HRV can be measured with a good quality activity bracelet and an App belonging to that. HRV data for the comparison group will be recorded with an identical time interval, during leisure time physical activity. This will be recorded once pre intervention and once post intervention.

    Time frame: To be measured in 2 weeks leading up to and during the intervention

  3. DNAm

    DNAm is a well-known form of an epigenetic process characterized by adding/removing methyl groups to cytosine-phosphate-guanine (CpG) sites, leading to changes in transcriptional ability without changes in the genetic code. Because it responds to environment yet is stable enough to capture biologically significant adaptation, DNAm represents a mechanism through which experiences can leave biological imprints via epigenetics. Epigenetics has been extensively studied in relation to stress-responsive neuroendocrine signaling, neuroplasticity, inflammation, and behavioral health outcomes, making it highly relevant to interventions targeting improvement in body regulation and emotional processing (Bagot et al., 2014; Cecil et al., 2020; Murgatroyd et al., 2009). Previous studies have consistently found methylation differences related to psychological stress in individuals with PTSD in HPA-regulating genes (such as NR3C1, FKBP5); additionally, DNAm changes in response to psychotherapy and m

    Time frame: To be measured in 2 weeks leading up to and during the intervention

  4. Brief Symptom Inventory (BSI)

    The Brief Symptom Inventory (BSI) is a self-rated measure of general psychopathology and psychological distress. The BSI contains 53 items reflecting psychological symptom patterns of psychiatric patients and non-patients. It comprises nine primary symptoms' scales and the global severity index (GSI). The primary symptom scales are: Anxiety, Depression, Interpersonal Sensitivity, Hostility, Obsessive Compulsiveness, Psychoticism, Paranoid Ideations, Phobic Anxiety, and Somatization. The answers are given on a five-point scale, from 0 = "not at all" to 4 = "extremely."

    Time frame: To be measured in 2 weeks leading up to and during the intervention

  5. Child and Youth Resilience Measure- Revised (CYRM-R)

    The Child and Youth Resilience Measure- Revised (CYRM-R) is a self-report measures of social ecological resilience (Resilience Research Centre, 2018). The CYRM-R is suitable for youth aged 10-23. It consists of 17-items and can be scored on 3- or 5-point Likert scales. The items in the measure are all positively worded and therefore scoring involves simple summing of responses. It can be used to evaluate the efficacy of interventions to build and maintain resilience. The measure has been translated into more than 20 languages and used in more than 150 research studies (Resilience Research Centre, 2018).

    Time frame: To be measured in 2 weeks leading up to and during the intervention

  6. Child PTSD Symptom Scale for DSM-5 (CPSS-5) for 12-18

    The Child PTSD Symptom Scale for DSM-5 (CPSS-5) is a 24-item self-report measure utilized to measure posttraumatic stress disorder symptoms and severity, and to assist in diagnosis for children and adolescents ages 8-18 (Fao et. Al., 2018). Items 1-20 assess for the presence of various PTSD symptoms and yield an overall symptom severity score. Items 1-24 measure the functional impairment of endorsed symptoms (Fao et. Al., 2018).

    Time frame: To be measured in 2 weeks leading up to and during the intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Chung T, Duquette J, Zhang-James Y, Hagen K, Biedrzycki JJ, Cote J, Nepal M, Carbone S, Khoury NM. Trauma Adapted Yoga as an Adjunct to Psychiatric Treatment on an Adolescent Inpatient Unit. Clin Child Psychol Psychiatry. 2026 Jul;31(3):945-959. doi: 10.1177/13591045261424539. Epub 2026 Feb 23. PubMed 41725599 ↗
  • Kerekes N, Soderstrom A, Holmberg C, Hedman Ahlstrom B. Yoga for children and adolescents: A decade-long integrative review on feasibility and efficacy in school-based and psychiatric care interventions. J Psychiatr Res. 2024 Dec;180:489-499. doi: 10.1016/j.jpsychires.2024.11.016. Epub 2024 Nov 6. PubMed 39547048 ↗
  • Gonzalez M, Pascoe MC, Yang G, de Manincor M, Grant S, Lacey J, Firth J, Sarris J. Yoga for depression and anxiety symptoms in people with cancer: A systematic review and meta-analysis. Psychooncology. 2021 Aug;30(8):1196-1208. doi: 10.1002/pon.5671. Epub 2021 Mar 24. PubMed 33763925 ↗
  • James-Palmer A, Anderson EZ, Zucker L, Kofman Y, Daneault JF. Yoga as an Intervention for the Reduction of Symptoms of Anxiety and Depression in Children and Adolescents: A Systematic Review. Front Pediatr. 2020 Mar 13;8:78. doi: 10.3389/fped.2020.00078. eCollection 2020. PubMed 32232017 ↗
  • Kohn M, Persson Lundholm U, Bryngelsson IL, Anderzen-Carlsson A, Westerdahl E. Medical yoga for patients with stress-related symptoms and diagnoses in primary health care: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:215348. doi: 10.1155/2013/215348. Epub 2013 Feb 26. PubMed 23533465 ↗
  • Lewis CR, Tafur J, Spencer S, Green JM, Harrison C, Kelmendi B, Rabin DM, Yehuda R, Yazar-Klosinski B, Cahn BR. Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD. Front Psychiatry. 2023 Feb 6;14:959590. doi: 10.3389/fpsyt.2023.959590. eCollection 2023. PubMed 36815187 ↗
  • Harkess KN, Ryan J, Delfabbro PH, Cohen-Woods S. Preliminary indications of the effect of a brief yoga intervention on markers of inflammation and DNA methylation in chronically stressed women. Transl Psychiatry. 2016 Nov 29;6(11):e965. doi: 10.1038/tp.2016.234. PubMed 27898068 ↗
  • Feldman MJ, Jolink TA, Alvarez GM, Fendinger NJ, Gaudier-Diaz MM, Lindquist KA, Muscatell KA. The roles of inflammation, affect, and interoception in predicting social perception. Brain Behav Immun. 2023 Aug;112:246-253. doi: 10.1016/j.bbi.2023.05.011. Epub 2023 May 30. PubMed 37263364 ↗
  • Estevao C. The role of yoga in inflammatory markers. Brain Behav Immun Health. 2022 Feb 1;20:100421. doi: 10.1016/j.bbih.2022.100421. eCollection 2022 Mar. PubMed 35199049 ↗
  • Eggart M, Valdes-Stauber J, Muller-Oerlinghausen B, Heinze M. Exploring Associations between C-Reactive Protein and Self-Reported Interoception in Major Depressive Disorder: A Bayesian Analysis. Brain Sci. 2023 Feb 18;13(2):353. doi: 10.3390/brainsci13020353. PubMed 36831896 ↗
  • Djalilova DM, Schulz PS, Berger AM, Case AJ, Kupzyk KA, Ross AC. Impact of Yoga on Inflammatory Biomarkers: A Systematic Review. Biol Res Nurs. 2019 Mar;21(2):198-209. doi: 10.1177/1099800418820162. Epub 2018 Dec 20. PubMed 30572710 ↗
  • Brown C, Carrington NK. Increasing access to school-based mental health services for youth subsequent to the COVID-19 pandemic. Health Aff Sch. 2025 Apr 5;3(4):qxaf073. doi: 10.1093/haschl/qxaf073. eCollection 2025 Apr. PubMed 40264701 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant-level data may be shared with authorized study collaborators for prespecified research analyses. Direct identifiers will not be shared. Access will be limited to only authorized researchers under applicable institutional policies, data-use agreements, and the IRB-approval. The shared data may include the de-identified analysis dataset and data dictionary. Data will not be made publicly available. Any additional sharing will require appropriate institutional and IRB review.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Study protocol, statistical analysis plan, informed consent form will be made available 1/2027 until the end of the trial. Clinical study report will be available once data analysis complete. De-identified data will be shared during the review periods with specified investigators.

Access criteria: Specified investigators include consultant Stef Pilkay as well as Nora Kerekes. Dr. Nora Kerekes, a professor of neuroscience in Sweden located at University West in the Department of Health Sciences, is researching this type of yoga for teens with trauma histories. This researcher is using similar measures and sharing data may eventually allow to greater understanding of how trauma adaptive yoga is helpful for trauma survivors. This will be reviewed in the informed consents/assents. We will also be partnering with consultant Stef Pilkay, a researcher on epigenetics in trauma at Syracuse University on adding biomarkers to our study to measure the effects of intervention vs control on epigenetic markers of inflammation, HPA axis regulation and stress response. For both, the PI will send this data through a secure hospital email and send the password separately using the same method in a different email.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.

Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 36 months is above that.

Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.

Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Nov 30, 2029
CompletionEst.
Dec 30, 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07934082
Responsible party
Nayla Khoury (Associate Professor, State University of New York - Upstate Medical University) — Principal investigator
First posted
Nov 12, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Nov 30, 2029 (estimated)
Completion
Dec 30, 2029 (estimated)
Last update
Nov 12, 2026

Study contacts

Nayla M Khoury, MD
Contact
Khouryn@upstate.edu
3154643276
Kathryn Hagen, PhD
Contact
HagenK@upstate.edu
315-464-3120

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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