Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 3, 2024
CompletedFirst Posted
Study publicly available on registry
April 12, 2024
CompletedApril 12, 2024
April 1, 2024
1.1 years
April 3, 2024
April 11, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Alph-Theta
EXPERIMENTAL15 sessions of alpha (8-12Hz) and theta (4-8Hz) push on Pz based on 10-20 international system
Sensory Motor Rhythm
EXPERIMENTAL15 sessions of sensory-motor rhythm (12-15Hz) push on Cz based on 10-20 international system
Interventions
neurofeedback training over five weeks, comprising 15 sessions. Each neurofeedback training session lasted 30 minutes.
Eligibility Criteria
You may qualify if:
- Normal hearing and vision,
- had never undergone neurofeedback sessions,
- diagnosed as GAD by a psychiatrist,
- no history of neurological disorders
- undergoing other therapies
You may not qualify if:
- started other treatments during the study
- missed more than one session
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shahid Beheshti University of Medical Science
Tehran, 4739-19395, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Clinical Psychology
Study Record Dates
First Submitted
April 3, 2024
First Posted
April 12, 2024
Study Start
June 1, 2022
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
April 12, 2024
Record last verified: 2024-04