Efficacy of Neurofeedback Training in Adults With ADHD
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Behavioral: Metacognitive TrainingBehavioral: Neurofeedback activeBehavioral: Neurofeedback sham
- Registration Number
- NCT01883765
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metacognitive Training Metacognitive Training Metacognitive training, cognitive behavioral therapy Neurofeedback sham Neurofeedback active Neurofeedback training is simulated to subjects in this condition Neurofeedback active Neurofeedback active Active neurofeedback training, theta/beta-protocol Neurofeedback sham Neurofeedback sham Neurofeedback training is simulated to subjects in this condition
- Primary Outcome Measures
Name Time Method Changes in ADHD symptomatology pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up) Conners' Adult ADHD Rating Scale (CAARS) Scores
- Secondary Outcome Measures
Name Time Method Changes in neuropsychological variables: Interference pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up) Stroop Color-Word Test, Interference scores
Changes in event-related potentials 1 pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up) Contingent Negative Variation Amplitudes
Changes in event-related potentials 2 pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up) Emitted P 300 Amplitudes
Changes in neuropsychological variables: Attention pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up) Continuous Performance Test (CPT), Errors in Omission and Errors in Commission
Changes in co-morbid depression scores pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up) Beck Depression Inventory (BDI) Scores
Changes in co-morbid anxiety scores pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up) State Trait Anxiety Inventory (STAI) Scores
Changes in neuropsychological variables: Cognitive Flexibility 1 pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up) Test for Attentional Performance (TAP) - Flexibility, RT in ms and Errors
Changes in electrophysiological markers pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up) Ln-transformed theta/beta ratio
Changes in neuropsychological variables: Cognitive Flexibility 2 pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up) Inventory for Complex Attention (INKA), Items correctly performed
Trial Locations
- Locations (1)
Universität Tübingen
🇩🇪Tuebingen, Baden-Württemberg, Germany