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Neurofeedback and Nomophobia in Young Adults

U

University of Salamanca

Status and phase

Invitation-only
Phase 4

Conditions

Anxiety
Biofeedback

Treatments

Other: Health education
Other: Neurofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT06188910
IBYE23_00001 - GRS2709/A1/2023

Details and patient eligibility

About

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 36 participants has been estimated, 18 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 20 neurofeedback sessions during 8 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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

36 participants in 2 patient groups

Neurofeedback
Experimental group
Description:
3 weekly 30-minute neurofeedback sessions per week for 12 weeks
Treatment:
Other: Neurofeedback
Control
Active Comparator group
Description:
Health education, a 25-minute session, on mobile phone addiction and promotion of healthy lifestyles
Treatment:
Other: Health education

Trial contacts and locations

1

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Central trial contact

José Ignacio Recio Rodriguez, PhD

Data sourced from clinicaltrials.gov

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