Health Condition 1: F411- Generalized anxiety disorder
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1-Adults aged 18 60 years. 2-Male or female outpatients. 3-Minimum threshold score on a standard anxiety scale (e.g. GAD-7 total score of greater than 5 and less than 14). 4-Ability and willingness to provide informed consent. 5-Sufficient language proficiency to complete assessments. 6-Willingness to comply with study procedures and intervention protocols.
Exclusion criteria
Exclusion criteria: 1-Current or past diagnosis of psychotic disorders, schizophrenia, or bipolar disorder. 2-Current primary diagnosis of another major psychiatric disorder (e.g., major depressive disorder, panic disorder, social phobia, OCD, PTSD, substance dependence) that requires treatment before GAD. 3-Current use of psychotropic medications or recent treatment with certain psychiatric drugs (e.g., SSRIs, Benzodiazepines, Beta-blockers). 4-Currently undergoing psychotherapy (e.g., CBT) or seeing a psychologist/psychiatrist for anxiety. 5-Person with risk of self-harm or suicidal ideation at the time of the screening or during trial will be referred to psychatric department of Higher Centre. 6-Unstable or clinically significant medical illness. 7-Pregnancy, planning to become pregnant, or breastfeeding 8-History of alcohol or substance use disorder (excluding nicotine and caffeine). 9-First-degree relative with or personal history of psychotic or bipolar disorder. 10-Any other condition or factor that, in the investigator s judgment, would interfere with participation or study outcomes. 11-Individuals who have completed participation in any other clinical trial during the past six (06) months. 12-Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Hamilton Anxiety Rating Scale i.e reduction in HAM-A scale scoreTimepoint: 0, 15, 30, 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in SF-36 Quality of life scores i.e increase in score pointsTimepoint: Assessment at Day- 0, 45 | — |
Countries
India