Neurofeedback training (NFT) has been frequently investigated as an alternative treatment for ADHD mainly in children and adolescents. However, randomized double-blind trials that include a sham-neurofeedback control group are lacking, as well as studies examining the efficacy of NFT in adult ADHD populations. The inclusion of a sham-neurofeedback group is crucial to monitor and exclude unspecific effects. This study aims to investigate the efficacy of NFT as compared to a sham-feedback condition and a cognitive behavioral treatment in adults with persistent ADHD. Efficacy is assessed on several outcome parameters, such as symptom severity, neuropsychological variables (e.g., attention, memory), and EEG parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
118
Universität Tübingen
Tübingen, Baden-Wurttemberg, Germany
Changes in ADHD symptomatology
Conners' Adult ADHD Rating Scale (CAARS) Scores
Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in co-morbid depression scores
Beck Depression Inventory (BDI) Scores
Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in co-morbid anxiety scores
State Trait Anxiety Inventory (STAI) Scores
Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in neuropsychological variables: Attention
Continuous Performance Test (CPT), Errors in Omission and Errors in Commission
Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in neuropsychological variables: Interference
Stroop Color-Word Test, Interference scores
Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in neuropsychological variables: Cognitive Flexibility 1
Test for Attentional Performance (TAP) - Flexibility, RT in ms and Errors
Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in neuropsychological variables: Cognitive Flexibility 2
Inventory for Complex Attention (INKA), Items correctly performed
Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in electrophysiological markers
Ln-transformed theta/beta ratio
Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in event-related potentials 1
Contingent Negative Variation Amplitudes
Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in event-related potentials 2
Emitted P 300 Amplitudes
Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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