Neurofeedback and Nomophobia in Young Adults

NCT06188910 | Completed

• 1 other identifier: IBYE23_00001 - GRS2709/A1/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anxiety; Biofeedback

Outcome Measures

Primary Outcomes (1)

• Anxiety

  Anxiety evaluated through Depression, Anxiety and Stress Scale 21-item (DASS-21). Minimum 0 - maximum 63

  Baseline, 3-months

Secondary Outcomes (2)

• Nomophobia

  Baseline, 3-months

• Sleep Quality

  Baseline, 3-months

Study Arms (2)

Neurofeedback

EXPERIMENTAL

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

Other: Neurofeedback

Control

ACTIVE COMPARATOR

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

Other: Health education

Interventions

Neurofeedback OTHER

Conducting neurofeedback sessions guided by a researcher

Also known as: Biofeedback

Neurofeedback

Health education OTHER

Health education on mobile phone addiction

Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator
• Gerencia Regional de Salud de Castilla y Leon: collaborator

Study Sites (1)

University of Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Related Publications (2)

• 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.

  PMID: 41409706 DERIVED

• 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.

  PMID: 39296829 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Neurofeedback; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• José Ignacio Recio Rodriguez, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)