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Completed

NCT Number: NCT06361953

Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder

Generalized anxiety disorder (GAD) is one of the most prevalent mental disorders in adults, marked by excessive and uncontrollable worry about various events or activities. It is accompanied by symptoms such as restlessness, irritability, fatigue, difficulty concentrating, problems with sleep, and somatic symptoms.

In addition, a critical and up-to-date comparison of different treatments for GAD is crucial due to their high costs and unsatisfactory outcomes. EEG neurofeedback training has not reached the same level of evidence as more extensively validated non-pharmacological treatments, such as cognitive behavioral therapy.This study aimed to compare the efficacy of two protocols: one targeting alpha-theta amplitude increase and the other concentrating on SMR.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shahid Beheshti University of Medical Science

Tehran, 4739-19395, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal hearing and vision,
  • had never undergone neurofeedback sessions,
  • diagnosed as GAD by a psychiatrist,
  • no history of neurological disorders
  • undergoing other therapies

Exclusion criteria

  • started other treatments during the study
  • missed more than one session

Treatment and study plan

EEG Neurofeedback

Device

neurofeedback training over five weeks, comprising 15 sessions. Each neurofeedback training session lasted 30 minutes.

Primary outcomes

  1. The Beck Anxiety Inventory

    Time frame: Pre-test, after 5 weeks and two month follow up

    higher scores mean higher depression

  2. The Perceived Stress Questionnaire

    Time frame: Pre-test, after 5 weeks and two month follow up

    higher scores mean higher stress

  3. Spielberger's state-trait anxiety test

    Time frame: Pre-test, after 5 weeks and two month follow up

    higher scores mean higher anxiety

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder: Sensory Motor Rhythm and Alpha-Theta

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2024
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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