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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback active | Experimental | Active neurofeedback training, theta/beta-protocol |
|
| Neurofeedback sham | Sham Comparator | Neurofeedback training is simulated to subjects in this condition |
|
| Metacognitive Training | Active Comparator | Metacognitive training, cognitive behavioral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback active | Behavioral |
| ||
| Neurofeedback sham |
| 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) |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Schönenberg, Dr | University Hospital Tuebingen | Principal Investigator |
| Martin Hautzinger, Prof. Dr. | University Hospital Tuebingen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universität Tübingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28803030 | Derived | Schonenberg M, Wiedemann E, Schneidt A, Scheeff J, Logemann A, Keune PM, Hautzinger M. Neurofeedback, sham neurofeedback, and cognitive-behavioural group therapy in adults with attention-deficit hyperactivity disorder: a triple-blind, randomised, controlled trial. Lancet Psychiatry. 2017 Sep;4(9):673-684. doi: 10.1016/S2215-0366(17)30291-2. Epub 2017 Aug 9. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D003117 | Color Vision Defects |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D014786 | Vision Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D011615 | Psychotherapy, Group |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D012960 | Socioenvironmental Therapy |
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| Behavioral |
|
|
| Metacognitive Training | Behavioral |
|
|
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) |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000077765 | Cone Dystrophy |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |