Clinical trial NCT01883765: Efficacy of Neurofeedback Training in Adults With ADHD
Official title: Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Triple-blind Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD, Neurofeedback, CBT
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2013-06-21
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in ADHD symptomatology
timeFrame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Secondary outcomes:
measure: Changes in co-morbid depression scores
timeFrame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
measure: Changes in co-morbid anxiety scores
timeFrame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
measure: Changes in neuropsychological variables: Attention
timeFrame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
measure: Changes in neuropsychological variables: Interference
timeFrame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
measure: Changes in neuropsychological variables: Cognitive Flexibility 1
timeFrame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
measure: Changes in neuropsychological variables: Cognitive Flexibility 2
timeFrame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
measure: Changes in electrophysiological markers
timeFrame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
measure: Changes in event-related potentials 1
timeFrame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
measure: Changes in event-related potentials 2
timeFrame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Universität Tübingen
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Tuebingen
name: Michael Schönenberg, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tuebingen
name: Martin Hautzinger, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.