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NCT06361953 Clinical Trial

Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06361953
Other study ID # IR.SBMU.MSP.REC. 1401. 161
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date July 1, 2023

Study information
Verified date April 2024
Source Shahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• EEG Neurofeedback
neurofeedback training over five weeks, comprising 15 sessions. Each neurofeedback training session lasted 30 minutes.

Locations
Country Name City State
Iran, Islamic Republic of Shahid Beheshti University of Medical Science Tehran

Sponsors (1)
Lead Sponsor Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Beck Anxiety Inventory higher scores mean higher depression Pre-test, after 5 weeks and two month follow up
Primary The Perceived Stress Questionnaire higher scores mean higher stress Pre-test, after 5 weeks and two month follow up
Primary Spielberger's state-trait anxiety test higher scores mean higher anxiety Pre-test, after 5 weeks and two month follow up
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