Neurofeedback and Nomophobia in Young Adults

NCT ID: NCT06188910

Last Updated: 2025-09-29

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety Biofeedback

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Neurofeedback

3 weekly 30-minute neurofeedback sessions per week for 12 weeks

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type OTHER

Conducting neurofeedback sessions guided by a researcher

Control

Health education, a 25-minute session, on mobile phone addiction and promotion of healthy lifestyles

Group Type ACTIVE_COMPARATOR

Health education

Intervention Type OTHER

Health education on mobile phone addiction

Interventions

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Neurofeedback

Conducting neurofeedback sessions guided by a researcher

Intervention Type OTHER

Health education

Health education on mobile phone addiction

Intervention Type OTHER

Other Intervention Names

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Biofeedback

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role collaborator

Gerencia Regional de Salud de Castilla y Leon

OTHER

Sponsor Role collaborator

University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

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José Ignacio Recio Rodriguez

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Ignacio Recio Rodriguez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Locations

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University of Salamanca

Salamanca, Salamanca, Spain

Site Status

Countries

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Spain

References

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Fernandez-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.

Reference Type DERIVED
PMID: 39296829 (View on PubMed)

Other Identifiers

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IBYE23_00001 - GRS2709/A1/2023

Identifier Type: -

Identifier Source: org_study_id

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