Neurofeedback and Nomophobia in Young Adults

Phase 4

• Conditions: Biofeedback; Anxiety
• Interventions: Other: Neurofeedback; Other: Health education

• Registration Number: NCT06188910
• Lead Sponsor: University of Salamanca

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2023-12-18
• Study First Posted: 2024-01-03
• Study Start: 2024-04-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neurofeedback	Neurofeedback	3 weekly 30-minute neurofeedback sessions per week for 12 weeks
Control	Health education	Health education, a 25-minute session, on mobile phone addiction and promotion of healthy lifestyles

Primary Outcome Measures

Name	Time	Method
Anxiety	Baseline, 3-months	Anxiety evaluated through Depression, Anxiety and Stress Scale 21-item (DASS-21). Minimum 0 - maximum 63

Secondary Outcome Measures

Name	Time	Method
Nomophobia	Baseline, 3-months	Nomophobia evaluated through Nomophobia Questionnaire (NMP-Q). Minimum 20 - maximum 140
Sleep Quality	Baseline, 3-months	Sleep quality evaluated through Atenas questionnaire. Minimum 0 - maximum 24

Trial Locations

Locations (1)

University of Salamanca; 🇪🇸 Salamanca, Spain