Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Device: EEG Neurofeedback

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 4739-19395
    • Shahid Beheshti University of Medical Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alph-Theta; 15 sessions of alpha (8-12Hz) and theta (4-8Hz) push on Pz based on 10-20 international system	Device: EEG Neurofeedback; neurofeedback training over five weeks, comprising 15 sessions. Each neurofeedback training session lasted 30 minutes.
Experimental: Sensory Motor Rhythm; 15 sessions of sensory-motor rhythm (12-15Hz) push on Cz based on 10-20 international system	Device: EEG Neurofeedback; neurofeedback training over five weeks, comprising 15 sessions. Each neurofeedback training session lasted 30 minutes.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: IR.SBMU.MSP.REC. 1401. 161

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No