Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Device: EEG Neurofeedback

• Registration Number: NCT06361953
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alph-Theta	EEG Neurofeedback	15 sessions of alpha (8-12Hz) and theta (4-8Hz) push on Pz based on 10-20 international system
Sensory Motor Rhythm	EEG Neurofeedback	15 sessions of sensory-motor rhythm (12-15Hz) push on Cz based on 10-20 international system

Primary Outcome Measures

Name	Time	Method
Spielberger's state-trait anxiety test	Pre-test, after 5 weeks and two month follow up	higher scores mean higher anxiety
The Beck Anxiety Inventory	Pre-test, after 5 weeks and two month follow up	higher scores mean higher depression
The Perceived Stress Questionnaire	Pre-test, after 5 weeks and two month follow up	higher scores mean higher stress

Trial Locations

Locations (1)

Shahid Beheshti University of Medical Science; 🇮🇷 Tehran, Iran, Islamic Republic of