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The effects of audiovisual stimulation associated with nutritional intervention in individuals with depression

Evaluation of the effects of audiovisual stimulation associated with a nutritional intervention on clinical symptoms, neurodegenerative biomarkers and cerebral activity in individuals with depression: a controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2t5svsq
Enrollment
Unknown
Registered
2021-12-07
Start date
2021-10-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety.

Interventions

Control Group: 72 participants will receive the audiovisual neurostimulation device for 20 minutes, three times a week, for eight weeks, totaling 24 sessions, but the equipment will be turned off, wit
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Sponsors

Universidade do Sul de Santa Catarina
Lead Sponsor
Universidade do Sul de Santa Catarina
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Present a medical diagnosis of depression; being in pharmacological treatment; age group between 18 and 60 years; female and male

Exclusion criteria

Exclusion criteria: Individuals who are under nutritional monitoring with a nutritionist; following a specific eating plan; individuals with diabetes mellitus (type I or II); epilepsy, people with hypersensitivity to light; immunosuppressive, oncological and infectious diseases; pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Improvement in the level of depression, assessed using the Hamilton Depression Scale with a 20% reduction in scale score.

Secondary

MeasureTime frame
Improvement in quality of life, assessed by applying the SF-36 Questionnaire, from the English Medical Outcomes study 36-item Short-Form Health Survey, in the translated and validated version for Portuguese, with a 20% increase in the score.;Improvement in the level of anxiety, to assess the level of anxiety, the Hamilton Anxiety Scale will be used, with a 20% reduction in the scale's score.;Improvement in sleep quality, for sleep quality assessment, the Pittsburgh Sleep Quality Index will be used, in the translated and validated version for Portuguese, with a 20% reduction in the questionnaire score.;Improvement in the level of stress and resilience, to measure the level of stress, the Perceived Stress Scale will be used, with a 20% reduction in the questionnaire score.;Improvement in the usual diet, the 24-hour recall will be used to assess the eating pattern of the participants. This is a self-applicable tool, which will contain information regarding the participant's 24 hours of food, with details on meals taken and times, food consumed and their respective quantities. A 20% improvement in food is expected.;Improvement in brain wave activity, brain activity will be measured by electroencephalogram, a 20% increase in alpha waves is expected. ;Improvement in heart rate variability will be assessed through heart rate variability with Nerve-Express software. A 20% increase in heart rate variability is expected.;Serum dosages of tumor necrosis factor (TNF), interleukin-1ß (IL-1ß), interleukin-6 (IL-6), interleukin-10 (IL-10), as well as leptin, melatonin, brain-derived neurotrophic factor (BDNF) and ß-enolase will be performed by the ELISA method (Enzyme-Linked Immunosorbent Assay), through the DuoSet ELISA kit for humans, according to the instructions of the kit manufacturer. 20% reductions are expected for tumor necrosis factor (TNF), interleukin-1 (IL-1ß) and interleukin-6 (IL-6), as well as a 20% increase for ß-enolase, interleukin-10 (IL-10), leptin, melatonin

Countries

Brazil

Contacts

Public ContactDaniel Martins
danielmartinsfisio@hotmail.com+55(048)999185021

Outcome results

None listed

Source: REBEC (via WHO ICTRP)