Condition 1: depression. Condition 2: Insomnia. Major depressive disorder, single episode Insomnia not due to a substance or known physiological condition
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients diagnosed with depression based on DSM-V criteria, confirmed by a psychiatrist Patients diagnosed with sleep disorders (insomnia) based on DSM-V criteria, confirmed by a psychiatrist Age range of 25 to 60 years Patients must be receiving standard psychiatric treatment Insomnia Severity Index (ISI) score greater than 8 but less than 21 Patients who voluntarily agree to participate in the study and sign a written informed consent form before the trial begins
Exclusion criteria
Exclusion criteria: Patients with serious underlying cardiovascular, liver, kidney, or hematopoietic diseases Insomnia caused by neurological disorders (e.g., stroke, Parkinson’s disease) History of sleep apnea Pregnant or breastfeeding women History of substance abuse History of allergy to herbal medicines Patient’s intolerance or unwillingness to continue treatment Patients not receiving standard psychiatric treatment for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia score based on the Insomnia Severity Index (ISI) questionnaire. Timepoint: At the beginning of the study (before starting the intervention) and 14 and 28 days after starting the medication. Method of measurement: Insomnia Severity Index (ISI) questionnaire.;Sleep quality score based on the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Timepoint: At the beginning of the study (before starting the intervention) and 14 and 28 days after starting the medication. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Brain temperament score based on the Fattahi Brain Temperament Questionnaire. Timepoint: At the beginning of the study (before starting the intervention) and 14 and 28 days after starting the medication. Method of measurement: Fattahi Brain Temperament Questionnaire.;Depression score based on the Beck’s Depression Inventory (BDI) questionnaire. Timepoint: At the beginning of the study (before starting the intervention) and 14 and 28 days after starting the medication. Method of measurement: Beck’s Depression Inventory (BDI) questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Shiraz University of Medical Sciences