Stress and anxiety in healthy volunteers Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults above 18 years of age 2. Those who give consent for the study
Exclusion criteria
Exclusion criteria: 1. Individuals less than 18 years of age 2. Active suicidal ideation, current or past diagnoses of manic-depressive disorders, post-traumatic stress disorder, psychotic disorders or any other psychiatric conditions requiring treatment 3. Individuals with claustrophobia, metal in the body, history of head injury, and current use of psychiatric medications 4. Those who don’t give consent for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 05/01/2023: 1. Depression, anxiety and stress measured with the Depression Anxiety Stress Scale (DASS-21) prior to the study and at the end of 12 weeks 2. Biomarkers measured using serological test prior to the study and at the end of 12 weeks 3. Gene expression profile including transcriptome analysis using mRNA sequencing prior to the study and at the end of 12 weeks Previous primary outcome measures: 1. Stress measured with the perceived stress scale (PSS) prior to the study and at the end of 12 weeks 2. Anxiety measured with the Depression Anxiety Stress Scale (DASS-21) prior to the study and at the end of 12 weeks 3. Impostor syndrome measured using the Impostor Syndrome Scale prior to the study and at the end of 12 weeks 4. Brain changes measured using functional magnetic resonance imaging (fMRI) prior to the study and at the end of 12 weeks 5. Biomarkers measured using serological test prior to the study and at the end of 12 weeks 6. Gene expression profile including NFkB (Nuclear Factor kappa B) transcriptome analysis using mRNA sequencing prior to the study and at the end of 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/01/2023: There are no secondary outcome measures Previous secondary outcome measures: Qualitative experience gathered using interviews at the end of the study | — |
Countries
India