Health Condition 1: G- Mental Health Health Condition 2: F411- Generalized anxiety disorder
Conditions
Interventions
None listed
Sponsors
Nirvikalpa Integrated Therapy Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed with Anxiety disorder (except phobia) according to DSM-5 Mild to moderate anxiety (HAM-A score 14-24) Able to understand English Those who are on stable pharmacotherapy in the past 6 weeks or those who are not willing to take pharmacotherapy Provide written informed consent
Exclusion criteria
Exclusion criteria: Active suicidal ideation or psychotic disorder Substance dependence (excluding nicotine and caffeine) Neurological or dermatological contraindications to the intervention Currently receiving structured psychotherapy for Anxiety Disorder Significant cognitive impairment that prevents participation in the study Severe anxiety (HAM-A score greater than or equal to 25) Current use of sleep medications (sedatives, hypnotics, or benzodiazepines for sleep) Dissociative symptoms as assessed by the MINI dissociative disorder module Personality disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hamilton Anxiety Rating Scale (HAM-A) scoreTimepoint: Baseline (Week 0) Full assessment battery Week 2 (Mid-intervention) HAM-A and ISI only Week 4 (Post-intervention) Full assessment battery plus Participant Experience Questionnaire Week 6 (Early follow-up) HAM-A and ISI only Week 8 (Follow-up) Full assessment battery Week 12 (Follow-up) Full assessment battery | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate Variability (HRV), Sleep quality (ISI), quality of life (WHOQOL-BREF), subjective well-being (WHO-5), cognitive function (Stroop Test), and participant experienceTimepoint: Baseline (Week 0) Full assessment battery along with HRV Week 2 (Mid-intervention) HAM-A, HRV and ISI only Week 4 (Post-intervention) Full assessment battery including HRV plus participant Experience Questionnaire Week 6 (Early follow-up) HAM-A and ISI only Week 8 (Follow-up) Full assessment battery Week 12 (Follow-up) Full assessment battery; The wait-list control (tau arm) and hypnotherapy arm will receive hypnoshirodhara for 4 weeks post study and same secondary outcome assessment will be done at 4 week | — |
Countries
India
Contacts
Public ContactDr Shyam Bhat
Director, Nirvikalpa Foundation
Outcome results
None listed