Efficacy of Neurofeedback Training in Adults With ADHD

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Triple-blind Randomized Placebo-controlled Study

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Neurofeedback active
* Behavioral: Neurofeedback sham
* Behavioral: Metacognitive Training


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: ADHD diagnosis sufficient knowledge of the German language Exclusion criteria: psychiatric disorder(s) lifetime (bipolar disorder, schizophrenia, schizoaffective disorder, borderline personality disorder) neurological disorder (e.g., epilepsy) current substance abuse disorder receives psychotherapy (e.g., CBT) or medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurofeedback active<br>Active neurofeedback training, theta/beta-protocol | Behavioral: Neurofeedback active<br> <br> |
| Sham Comparator: Neurofeedback sham<br>Neurofeedback training is simulated to subjects in this condition | Behavioral: Neurofeedback active<br> <br> Behavioral: Neurofeedback sham<br> <br> * Other names: placebo neurofeedback, simulated neurofeedback;|
| Active Comparator: Metacognitive Training<br>Metacognitive training, cognitive behavioral therapy | Behavioral: Metacognitive Training<br> <br> * Other names: cognitive behavioral therapy, group therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in ADHD symptomatology | Conners' Adult ADHD Rating Scale (CAARS) Scores | pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in co-morbid depression scores | Beck Depression Inventory (BDI) Scores | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Neurofeedback, CBT