106
Participants
Start Date
January 31, 2017
Primary Completion Date
June 30, 2019
Study Completion Date
June 30, 2019
Biofeedback and Neurofeedback Training
The protocol will consist of 5 sessions of skin temperature biofeedback and 20 sessions of a neurofeedback training protocol that will consist of Alpha-Theta ratio up-training. The aim of the training is to reach a crossover state, were initially Alpha activity will increase and then in a deeper state, the Theta activity will take over. This state is associated with a reverie and disidentification with problems, stress or traumatic experiences. Therefore, the subjects will learn how to increase their Theta/Alpha ratio.
Varenicline use for smoking cessation
The protocol will consist 1 mg varenicline use twice daily following a 1-week titration for 3 months.
Sham Neurofeedback
Subjects will receive equal sessions of sham neurofeedback, and thus serve as a control group for the analysis and design of the study.
Passive Control
Subjects will not receive any intervention, but they will be measured via a clinical and psychometric evaluation with a time-difference of 3 months. This is equal to the intervention time. Hence, the subjects in this intervention type will serve as a control group for the analysis and design of the study.
AAI Scientific Cultural Services Ltd (AAISCS), Nicosia
National Association of General Practitioners in Bulgaria, Sofia
Laboratory of Medical Physics, AUTH, Thessaloniki
AAI Scientific Cultural Services Ltd (AAISCS)
OTHER
NATIONAL ASSOCIATION OF GENERAL PRACTITIONERS IN BULGARIA
UNKNOWN
Aristotle University Of Thessaloniki
OTHER