Neurofeedback and Nomophobia in Young Adults

March 5, 2024 updated by: José Ignacio Recio Rodriguez, University of Salamanca

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: José Ignacio Recio Rodriguez, PhD
  • Phone Number: 650330694
  • Email: donrecio@usal.es

Study Locations

  • Spain
      • Salamanca, Spain, 37005
        • José Ignacio Recio Rodriguez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurofeedback
3 weekly 30-minute neurofeedback sessions per week for 12 weeks
Other: Neurofeedback
Conducting neurofeedback sessions guided by a researcher
Other Names:
  • Biofeedback
Active Comparator: Control
Health education, a 25-minute session, on mobile phone addiction and promotion of healthy lifestyles
Other: Health education
Health education on mobile phone addiction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Baseline, 3-months
Anxiety evaluated through Depression, Anxiety and Stress Scale 21-item (DASS-21). Minimum 0 - maximum 63
Baseline, 3-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nomophobia
Time Frame: Baseline, 3-months
Nomophobia evaluated through Nomophobia Questionnaire (NMP-Q). Minimum 20 - maximum 140
Baseline, 3-months
Sleep Quality
Time Frame: Baseline, 3-months
Sleep quality evaluated through Atenas questionnaire. Minimum 0 - maximum 24
Baseline, 3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salamanca

Collaborators

Instituto de Investigación Biomédica de Salamanca
Gerencia Regional de Salud de Castilla y Leon

Investigators

  • Principal Investigator: José Ignacio Recio Rodriguez, PhD, University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBYE23_00001 - GRS2709/A1/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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