Health Condition 1: F419- Anxiety disorder, unspecified Health Condition 2: F411- Generalized anxiety disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed with Generalized Anxiety Disorder (GAD) or Other/Unspecified Anxiety Disorder according to DSM-5 criteria. Participants with at least mild anxiety symptoms (GAD-7 score more than or equals to 5). Participants with or without pharmacotherapy. If on pharmacotherapy, then participants willing to keep dosage of medications stable during the trial period. Able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: History of bipolar disorder, schizophrenia, substance use or dependence (excluding tobacco), obsessive-compulsive disorder (OCD), severe depression, psychosis, phobias, or panic disorder. Pregnancy. Any severe medical comorbidities. Participation in structured yoga therapy or online/offline pranayama or any mind-body technique at least once per week in last 3 months. Participation in structured cognitive behavioral therapy (CBT) for anxiety within the past 3 months. Not on a stable pharmacological dose for at least 4 weeks prior to enrolment. Nasal abnormalities (e.g., nasal septum deviation, polyps). Contraindications for fMRI (e.g., metal implants, claustrophobia, inability to remain still) will be assessed using a fMRI safety checklist before the scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported anxiety severity measured by PROMIS Positive and Negative affect measured by PANASTimepoint: Baseline (pre-intervention), weekly assessments during Weeks 1 8, with final assessment at the end of Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinician-rated anxiety severity assessed using the Hamilton Anxiety Rating Scale (HAM-A). Timepoint: Baseline and end of Week 8 (post-intervention). ;Intrinsic functional connectivity will be assessed and resting-state functional MRI will be done.Timepoint: Baseline and end of Week 8 (post-intervention).;Autonomic nervous system function assessed using heart rate variability (HRV) measures.Timepoint: Baseline and end of Week 8 (post-intervention).;Cognitive performance trends assessed using mobile-based cognitive tasks delivered via the MyCap application. Timepoint: Weekly during the 8-week intervention period.;Individual constitutional and personality traits assessed using the Brief Prakriti Inventory (BPI) and Vedic Personality Inventory (VPI).Timepoint: Baseline only. | — |
Countries
India
Contacts
Department of Integrative Medicine, NIMHANS