Recruiting

Trauma Adapted Yoga

Sponsor:

State University of New York - Upstate Medical University

Code:

NCT07934082

Conditions

Psychiatric Disorders

Emotional Dysregulation

Eligibility Criteria

Sex: All

Age: 12 - 29

Healthy Volunteers: Not accepted

Interventions

Trauma Adapted Yoga

Physical Activity Control

Study Details

Brief 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.

Conditions

Psychiatric Disorders

Emotional Dysregulation

Study ID

NCT07934082

Start date

Nov 15, 2026

Status verified date

Nov, 2026

Completion date

Dec 30, 2029

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 29

Healthy Volunteers: Not accepted

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:

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).

Study Design

Enrollment

143 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Physical Activity

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

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.

Interventions

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.

Physical Activity Control

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

Primary outcome measure

  • Positive Affect and Negative Affect-Extended. [ Time Frame: Within 2 weeks before starting intervention and within 2 weeks post intervention ]
  • Multidimensional Assessment of Interoceptive Awareness (MAIA) [ Time Frame: Within 2 weeks before starting intervention and within 2 weeks post intervention ]
  • Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Within 2 weeks before starting intervention and within 2 weeks post intervention ]

Central Contacts and Locations

Central contacts

Locations

SUNY Upstate Psychiatry Department

Recruiting

Syracuse, New York, United States, 13210

Contacts

Nayla M Khoury, MD, MPH

3154643276Khouryn@upstate.edu

Principal Investigator:

Nayla M Khoury, MD, MPH

More Information

Sponsor

State University of New York - Upstate Medical University

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by State University of New York - Upstate Medical University on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.