Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD, Neurofeedback, CBT
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.
Interventions
Sponsors
German Research Foundation
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 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 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 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 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 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 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: 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 |
Countries
Germany
Outcome results
None listed