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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06361953
Enrollment
40
Registered
2024-04-12
Start date
2022-06-01
Completion date
2023-07-01
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder

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.

Interventions

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

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Beck Anxiety InventoryPre-test, after 5 weeks and two month follow uphigher scores mean higher depression
The Perceived Stress QuestionnairePre-test, after 5 weeks and two month follow uphigher scores mean higher stress
Spielberger's state-trait anxiety testPre-test, after 5 weeks and two month follow uphigher scores mean higher anxiety

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026