Depression
Conditions
Interventions
This research is characterized as a randomized, controlled clinical trial. Sixty participants will be randomized (30 to the intervention group and 30 to the placebo group). Allocation to the treatment
heads, in both the active and sham groups, using continuous infrared light, invisible to the human eye. Three irradiation points
Sponsors
Sociedade de Educação Superior e Cultura Brasil S.A.
Universidade do Sul de Santa Catarina
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Individuals aged 18 to 60 years; both sexes; with depression as measured by achieving the minimum scores on the Patient Health Questionnaire-9 (PHQ-9) for mild or moderate depression
Exclusion criteria
Exclusion criteria: Risk of suicidal ideation; severe depression assessed using PHQ-9 scores; individuals with diseases that may be stimulated by light; immunocompromised individuals; cancer patients; individuals with infectious diseases or in a febrile state; epileptic individuals; pregnant and/or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that volunteers will see an improvement in their depression levels, as verified through the Patient Health Questionnaire (PHQ-9). This is a brief, validated self-assessment instrument widely used in clinical research and sensitive to changes over time. The PHQ-9 is a questionnaire composed of nine questions that aim to assess the presence of symptoms characteristic of major depression, as established by the DSM-IV. Each question seeks to identify the frequency of each symptom over the past two weeks, using a Likert scale of 0 to 3 points. The answers correspond to the following frequency levels: "never", "some days", "more than half the days" and "almost every day", respectively. In addition to the nine questions, the questionnaire also includes a tenth question that assesses how these symptoms interfere with the performance of daily activities, such as work and study. In Brazil, the instrument has been validated for use in adults. The distribution of scores ranges from 0 to 27 points, classifying according to the diagnostic levels of depression: absence of depression (0-4), mild symptoms (5-9), moderate symptoms (10-19), and severe symptoms (20-27). Response to treatment, also called recovery, indicates a significant reduction in depression symptoms in response to therapeutic intervention. It is generally defined as a decrease of a specific percentage in the score of a depression rating scale, such as the PHQ-9. Recovery from depression can be defined as a 50% or greater reduction in the total scale score. Remission of depression, in turn, represents the significant absence of depressive symptoms after treatment. It is generally defined as achieving a score below a certain threshold on a depression rating scale, indicating the absence or only mild symptoms. For the PHQ-9, a score below 5 can be considered remission. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that the quality of life of the volunteers will improve with the treatment compared to the placebo at the end of the protocol. This will be verified using the standardized SF-12 (Short Form Health Survey 12) quality of life questionnaire, in its translated and validated version for Portuguese. It is a multidimensional questionnaire consisting of 12 items subdivided into eight scales: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects, and mental health. The final score ranges from zero to one hundred, where zero represents the worst prognosis.;The treatment is expected to improve sleep quality indices compared to placebo at the end of the protocol. Sleep will be assessed using the Pittsburgh Quality of Sleep Index (PSQI-BR), which was validated for Portuguese in 2011. The index evaluates sleep quality and disturbances over a one-month period. It is, therefore, a standardized, simple, and well-accepted instrument. The instrument consists of nineteen questions, each scoring from 0 to 3. The overall score results from the sum of all scores and can range from 0 to 21. The higher the score, the worse the sleep quality. Scores > 5 are considered indicators of poor sleep quality. The purpose of the tool is to assess sleep quality using the overall score and the following domains: subjective quality; latency; duration; habitual efficiency; disturbances; use of sleep medication; and daytime dysfunction.;It is expected that participants in the study will see an improvement in their anxiety levels compared to the placebo group at the end of the protocol. Anxiety will be assessed using the Generalized Anxiety Disorders Scale (GAD-7), one of the most widely used screening instruments in the world, composed of 7 questions that determine the level of anxiety by score: Mild anxiety: 5 to 9 points; Moderate anxiety: 10 to 14 points; and Severe anxiety: 15 to 21 points.;It is expected to observe the prefro | — |
Countries
Brazil
Contacts
Public ContactDaniel Martins
Universidade do Sul de Santa Catarina
Outcome results
None listed