Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2024-04-01
2025-02-28
Brief Summary
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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 40 participants has been estimated, 20 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 25 neurofeedback sessions during 12 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Neurofeedback
3 weekly 30-minute neurofeedback sessions per week for 12 weeks
Neurofeedback
Conducting neurofeedback sessions guided by a researcher
Control
Health education, a 25-minute session, on mobile phone addiction and promotion of healthy lifestyles
Health education
Health education on mobile phone addiction
Interventions
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Neurofeedback
Conducting neurofeedback sessions guided by a researcher
Health education
Health education on mobile phone addiction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 brain injury or other problems contraindicating the use of neurofeedback.
18 Years
30 Years
ALL
Yes
Sponsors
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Instituto de Investigación Biomédica de Salamanca
OTHER
Gerencia Regional de Salud de Castilla y Leon
OTHER
University of Salamanca
OTHER
Responsible Party
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José Ignacio Recio Rodriguez
Principal investigator
Principal Investigators
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José Ignacio Recio Rodriguez, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Salamanca
Locations
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University of Salamanca
Salamanca, Salamanca, Spain
Countries
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References
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Fernandez-Crespo M, Recio-Rodriguez JI, Lee HC, Alonso-Dominguez R, Montejo AL, Hernandez-Gonzalez L, Iglesias Sierra V, Rihuete-Galve MI. Study protocol of a proposed Neurofeedback-Assisted Mindfulness Training Program on symptoms of anxiety and psychological distress associated with smartphone use in young adults: a randomized controlled trial. Front Public Health. 2024 Sep 4;12:1410932. doi: 10.3389/fpubh.2024.1410932. eCollection 2024.
Other Identifiers
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IBYE23_00001 - GRS2709/A1/2023
Identifier Type: -
Identifier Source: org_study_id
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