Neurofeedback and Nomophobia in Young Adults

Anxiety Clinical Trial

Official title:

Effectiveness of a Neurofeedback Intervention on Symptoms of Anxiety and Psychological Distress Associated With Smartphone Use in Young Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06188910
• Other study ID #: IBYE23_00001 - GRS2709/A1/2023
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Salamanca
• Contact: José Ignacio Recio Rodriguez, PhD
• Phone: 650330694
• Email: donrecio[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Biofeedback

Intervention

Other:
• Neurofeedback
Conducting neurofeedback sessions guided by a researcher
• Health education
Health education on mobile phone addiction

Locations

Country	Name	City	State
Spain	José Ignacio Recio Rodriguez	Salamanca

Sponsors (3)

Lead Sponsor	Collaborator
University of Salamanca	Gerencia Regional de Salud de Castilla y Leon, Instituto de Investigación Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	Anxiety evaluated through Depression, Anxiety and Stress Scale 21-item (DASS-21). Minimum 0 - maximum 63	Baseline, 3-months
Secondary	Nomophobia	Nomophobia evaluated through Nomophobia Questionnaire (NMP-Q). Minimum 20 - maximum 140	Baseline, 3-months
Secondary	Sleep Quality	Sleep quality evaluated through Atenas questionnaire. Minimum 0 - maximum 24	Baseline, 3-months