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Comparing the effectiveness of drug therapy and combined neurofeedback and direct intracranial current stimulation in sleep quality, insomnia severity and depression symptoms

Comparing the effectiveness of drug therapy and combined neurofeedback and direct intracranial current stimulation in sleep quality, insomnia severity and depression symptoms

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241015063379N1
Enrollment
45
Registered
2024-11-01
Start date
2024-11-10
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Depressive disorder. Major depressive disorder, single episode

Interventions

Intervention 1: The first intervention group: This group is subjected to the intracranial direct current stimulation (tDCS) method, which is performed for 20 sessions, each session lasting 20 minutes.
In this way, the brain condition of the people is evaluated based on the brain map (QEEG) and then the treatment protocols according to the 10-20 division system are adjusted and implemented. These pr

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Diagnosis of depression and chronic insomnia Age 18 to 60 years Not suffering from other serious neurological and psychiatric diseases Not using antidepressants or sleeping pills in the last month Willingness to participate in regular therapy sessions

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Changes in the use of drugs affecting sleep and depression during the research period Lack of regular attendance at treatment sessions Suffering from severe physical or neurological diseases that interfere with treatment Alcohol or drug use

Design outcomes

Primary

MeasureTime frame
Depressive. Timepoint: before the beginning of the intervention and after the end of the intervention in each session. Method of measurement: Beck Depression Inventory (BDI).;Insomnia severity. Timepoint: before the beginning of the intervention and after the end of the intervention in each session. Method of measurement: Insomnia Severity Index (ISI).;Sleep Quality. Timepoint: before the beginning of the intervention and after the end of the intervention in each session. Method of measurement: Petersburg Sleep Quality Questionnaire (PSQI).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaezeh Memari

Islamic Azad University, Semnan branch

faezehmemari@gmail.com+98 51 3723 7919

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026