AnxietyNCT06188910
Neurofeedback and Nomophobia in Young Adults
A study testing Neurofeedback and Health education in people with Anxiety and Biofeedback, run by University of Salamanca at 1 site in Spain.
Trial summary
Introduction: Given the growing increase in addiction to social networks and smartphone use in young people and its implications for health, it is necessary to investigate effective interventions for the appropriate use of these technologies and coping with possible signs of addiction. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Biofeedback
- What is being tested?
- Neurofeedback and Health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2024to 28 Feb 2025
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have one or more mobile devices such as smartphones.
- Have a compatible mobile device to install and use the Muse: EEG Meditation \& Sleep application.
- Be fully functional.
- Willingness to voluntarily participate in the study and sign the informed consent form.
Who cannot join
- History of severe psychiatric disorders (such as schizoaffective disorders, bipolar disorder, major depressive episode with symptoms or other non-organic psychotic disorders) requiring psychiatric treatment in the 6 months prior to study entry.
- History of brain injury or other problems contraindicating the use of neurofeedback.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Neurofeedback Intervention on Symptoms of Anxiety and Psychological Distress Associated With Smartphone Use in Young Adults
Introduction: Given the growing increase in addiction to social networks and smartphone use in young people and its implications for health, it is necessary to investigate effective interventions for the appropriate use of these technologies and coping with possible signs of addiction.
Objective: To evaluate the effect of an intervention based on neurofeedback techniques on anxiety and other disorders associated with problematic use of mobile phones and the internet in young adults.
Read more
Methodology: Randomised controlled clinical trial with two parallel groups: an intervention group (IG) and a control group (CG). The study population will be young adults aged 18-30 years. A sample size of 40 participants has been estimated, 20 in each group to detect a difference of 3.9 points or more on the DASS-21 anxiety questionnaire.
All participants will receive an educational workshop on the responsible use of new technologies and the promotion of healthy lifestyles. The IG, in addition to this educational workshop, will receive 25 neurofeedback sessions during 12 weeks, 2-3 sessions/week with the MUSE neurofeedback device.
A baseline and 3-month post-intervention assessment will be conducted for both groups to study change variables related to smartphone addiction (Smartphone Addiction Scale-Short Version (SAS-SV)), nomophobia (Nomophobia Questionnaire (NMP-Q)), depression, anxiety and stress (Depression, Anxiety and Stress Scale 21-item (DASS-21)) and sleep quality.
- Conditions
- Anxiety, Biofeedback
- Being tested
- Neurofeedback, Health education
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackOther
Also called Biofeedback
Conducting neurofeedback sessions guided by a researcher
Health educationOther
Health education on mobile phone addiction
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | 3 weekly 30-minute neurofeedback sessions per week for 12 weeks Receives: Other: Neurofeedback |
| Control | Active comparator | Health education, a 25-minute session, on mobile phone addiction and promotion of healthy lifestyles Receives: Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety evaluated through Depression, Anxiety and Stress Scale 21-item (DASS-21). Minimum 0 - maximum 63
Measured: Baseline, 3-months
Secondary outcomes (2)
Nomophobia
Nomophobia evaluated through Nomophobia Questionnaire (NMP-Q). Minimum 20 - maximum 140
Measured: Baseline, 3-months
Sleep Quality
Sleep quality evaluated through Atenas questionnaire. Minimum 0 - maximum 24
Measured: Baseline, 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca, Gerencia Regional de Salud de Castilla y Leon
- Responsible party
- Principal investigator, José Ignacio Recio Rodriguez, University of Salamanca
- Investigators
- José Ignacio Recio Rodriguez, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188910
- Sponsor's protocol ID
- IBYE23_00001 - GRS2709/A1/2023
- Status last verified
- Sep 2025
- First submitted
- 18 Dec 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez-Crespo M, Rihuete-Galve MI, Sanchez-Aguadero N, Sanchez-Sanchez N, Gonzalez-Sanchez J, Garcia-Yu IA, Lee HC, Recio-Rodriguez JI. Efficacy of neurofeedback-assisted mindfulness for anxiety and nomophobia in Spanish young adults: a randomized controlled trial. Front Public Health. 2025 Dec 2;13:1712564. doi: 10.3389/fpubh.2025.1712564. eCollection 2025.
PubMed 41409706Fernandez-Crespo M, Recio-Rodriguez JI, Lee HC, Alonso-Dominguez R, Montejo AL, Hernandez-Gonzalez L, Iglesias Sierra V, Rihuete-Galve MI. Study protocol of a proposed Neurofeedback-Assisted Mindfulness Training Program on symptoms of anxiety and psychological distress associated with smartphone use in young adults: a randomized controlled trial. Front Public Health. 2024 Sep 4;12:1410932. doi: 10.3389/fpubh.2024.1410932. eCollection 2024.
PubMed 39296829
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Neurofeedback Intervention on Symptoms of Anxiety and Psychological Distress Associated With Smartphone Use in Young Adults
- ClinicalTrials.gov ID
- NCT06188910
- Acronym / sponsor ID
- IBYE23_00001 - GRS2709/A1/2023
- Conditions
- Anxiety, Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca, Gerencia Regional de Salud de Castilla y Leon
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 3 Jan 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.
Introduction: Given the growing increase in addiction to social networks and smartphone use in young people and its implications for health, it is necessary to investigate effective interventions for the appropriate use of these technologies and coping with possible signs of addiction.
Objective: To evaluate the effect of an intervention based on neurofeedback techniques on anxiety and other disorders associated with problematic use of mobile phones and the internet in young adults.
Methodology: Randomised controlled clinical trial with two parallel groups: an intervention group (IG) and a control group (CG). The study population will be young adults aged 18-30 years. A sample size of 40 participants has been estimated, 20 in each group to detect a difference of 3.9 points or more on the DASS-21 anxiety questionnaire.
All participants will receive an educational workshop on the responsible use of new technologies and the promotion of healthy lifestyles. The IG, in addition to this educational workshop, will receive 25 neurofeedback sessions during 12 weeks, 2-3 sessions/week with the MUSE neurofeedback device.
A baseline and 3-month post-intervention assessment will be conducted for both groups to study change variables related to smartphone addiction (Smartphone Addiction Scale-Short Version (SAS-SV)), nomophobia (Nomophobia Questionnaire (NMP-Q)), depression, anxiety and stress (Depression, Anxiety and Stress Scale 21-item (DASS-21)) and sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Other: Neurofeedback3 weekly 30-minute neurofeedback sessions per week for 12 weeks |
| Control | Active comparator | Other: Health educationHealth education, a 25-minute session, on mobile phone addiction and promotion of healthy lifestyles |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Have one or more mobile devices such as smartphones.
- Have a compatible mobile device to install and use the Muse: EEG Meditation \& Sleep application.
- Be fully functional.
- Willingness to voluntarily participate in the study and sign the informed consent form.
Key exclusion criteria (2 listed)
- History of severe psychiatric disorders (such as schizoaffective disorders, bipolar disorder, major depressive episode with symptoms or other non-organic psychotic disorders) requiring psychiatric treatment in the 6 months prior to study entry.
- History of brain injury or other problems contraindicating the use of neurofeedback.
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 |
|---|---|---|
| NeurofeedbackAlso: BiofeedbackConducting neurofeedback sessions guided by a researcher | Other | Neurofeedback |
| Health educationHealth education on mobile phone addiction | Other | Control |
Primary outcome
Anxiety
Time frame: Baseline, 3-months
Anxiety evaluated through Depression, Anxiety and Stress Scale 21-item (DASS-21). Minimum 0 - maximum 63
2 secondary outcomes
Nomophobia
Time frame: Baseline, 3-months
Sleep Quality
Time frame: Baseline, 3-months
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 29 Sep 2025.
- Derived from this study: PubMed 41409706Fernandez-Crespo M, Rihuete-Galve MI, Sanchez-Aguadero N, Sanchez-Sanchez N, Gonzalez-Sanchez J, Garcia-Yu IA, Lee HC, Recio-Rodriguez JI. Efficacy of neurofeedback-assisted mindfulness for anxiety and nomophobia in Spanish young adults: a randomized controlled trial. Front Public Health. 2025 Dec 2;13:1712564. doi: 10.3389/fpubh.2025.1712564. eCollection 2025.
- Derived from this study: PubMed 39296829Fernandez-Crespo M, Recio-Rodriguez JI, Lee HC, Alonso-Dominguez R, Montejo AL, Hernandez-Gonzalez L, Iglesias Sierra V, Rihuete-Galve MI. Study protocol of a proposed Neurofeedback-Assisted Mindfulness Training Program on symptoms of anxiety and psychological distress associated with smartphone use in young adults: a randomized controlled trial. Front Public Health. 2024 Sep 4;12:1410932. doi: 10.3389/fpubh.2024.1410932. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
José Ignacio Recio Rodriguez, PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback and Health education in people with Anxiety and Biofeedback, run by University of Salamanca at 1 site in Spain.
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 4 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 29 Sep 2025. 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 Spain. 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?
Anxiety (time frame: Baseline, 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06188910, which also lists 2 linked publications.
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 29 Sep 2025.