Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder

NCT ID: NCT06361953

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Generalized Anxiety Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alph-Theta

15 sessions of alpha (8-12Hz) and theta (4-8Hz) push on Pz based on 10-20 international system

Group Type EXPERIMENTAL

EEG Neurofeedback

Intervention Type DEVICE

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

Sensory Motor Rhythm

15 sessions of sensory-motor rhythm (12-15Hz) push on Cz based on 10-20 international system

Group Type EXPERIMENTAL

EEG Neurofeedback

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EEG Neurofeedback

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abbas Masjedi Arani

Head of Clinical Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shahid Beheshti University of Medical Science

Tehran, , Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IR.SBMU.MSP.REC. 1401. 161

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

4th Ventricular Compression Technique on Anxiety
NCT06389461 NOT_YET_RECRUITING NA
Cognitive-Behavior Therapy for Insomnia
NCT00869934 COMPLETED PHASE4
Therapeutic Massage for Generalized Anxiety Disorder
NCT00515242 COMPLETED PHASE1/PHASE2