Clinical trial NCT06188910: Neurofeedback and Nomophobia in Young Adults
Official title: Effectiveness of a Neurofeedback Intervention on Symptoms of Anxiety and Psychological Distress Associated with Smartphone Use in Young Adults
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Anxiety
Biofeedback
Lead sponsor: University of Salamanca
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
name: Gerencia Regional de Salud de Castilla y Leon
First posted: 2024-01-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety
timeFrame: Baseline, 3-months
Secondary outcomes:
measure: Nomophobia
timeFrame: Baseline, 3-months
measure: Sleep Quality
timeFrame: Baseline, 3-months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: University of Salamanca
Study officials:
affiliation: University of Salamanca
name: José Ignacio Recio Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References: