Generalized Anxiety DisorderNCT06361953
Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder
A study testing EEG Neurofeedback in people with Generalized Anxiety Disorder, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- EEG Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 1 Jun 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Normal hearing and vision,
- had never undergone neurofeedback sessions,
- diagnosed as GAD by a psychiatrist,
- no history of neurological disorders
- undergoing other therapies
Who cannot join
- started other treatments during the study
- missed more than one session
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- EEG Neurofeedback
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG NeurofeedbackDevice
neurofeedback training over five weeks, comprising 15 sessions. Each neurofeedback training session lasted 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Alph-Theta | Experimental | 15 sessions of alpha (8-12Hz) and theta (4-8Hz) push on Pz based on 10-20 international system Receives: Device: EEG Neurofeedback |
| Sensory Motor Rhythm | Experimental | 15 sessions of sensory-motor rhythm (12-15Hz) push on Cz based on 10-20 international system Receives: Device: EEG Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Beck Anxiety Inventory
higher scores mean higher depression
Measured: Pre-test, after 5 weeks and two month follow up
The Perceived Stress Questionnaire
higher scores mean higher stress
Measured: Pre-test, after 5 weeks and two month follow up
Spielberger's state-trait anxiety test
higher scores mean higher anxiety
Measured: Pre-test, after 5 weeks and two month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Jun 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbas Masjedi Arani, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361953
- Sponsor's protocol ID
- IR.SBMU.MSP.REC. 1401. 161
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder: Sensory Motor Rhythm and Alpha-Theta
- ClinicalTrials.gov ID
- NCT06361953
- Acronym / sponsor ID
- IR.SBMU.MSP.REC. 1401. 161
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alph-Theta | Experimental | Device: EEG Neurofeedback15 sessions of alpha (8-12Hz) and theta (4-8Hz) push on Pz based on 10-20 international system |
| Sensory Motor Rhythm | Experimental | Device: EEG Neurofeedback15 sessions of sensory-motor rhythm (12-15Hz) push on Cz based on 10-20 international system |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Normal hearing and vision,
- had never undergone neurofeedback sessions,
- diagnosed as GAD by a psychiatrist,
- no history of neurological disorders
- undergoing other therapies
Key exclusion criteria (2 listed)
- started other treatments during the study
- missed more than one session
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG Neurofeedbackneurofeedback training over five weeks, comprising 15 sessions. Each neurofeedback training session lasted 30 minutes. | Device | Alph-Theta, Sensory Motor Rhythm |
Primary outcome
The Beck Anxiety Inventory
Time frame: Pre-test, after 5 weeks and two month follow up
higher scores mean higher depression
The Perceived Stress Questionnaire
Time frame: Pre-test, after 5 weeks and two month follow up
higher scores mean higher stress
Spielberger's state-trait anxiety test
Time frame: Pre-test, after 5 weeks and two month follow up
higher scores mean higher anxiety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG Neurofeedback in people with Generalized Anxiety Disorder, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Beck Anxiety Inventory (time frame: Pre-test, after 5 weeks and two month follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.