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Completed

NCT Number: NCT01883765

Efficacy of Neurofeedback Training in Adults With ADHD

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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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Color Vision Defects Cone Dystrophy Eye Diseases Eye Diseases, Hereditary Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universität Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurofeedback active

Behavioral

Neurofeedback sham

Behavioral

Other names: placebo neurofeedback, simulated neurofeedback

Metacognitive Training

Behavioral

Other names: cognitive behavioral therapy, group therapy

Primary outcomes

  1. Changes in ADHD symptomatology

    Time frame: 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 outcomes

  1. Changes in co-morbid depression scores

    Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)

    Beck Depression Inventory (BDI) Scores

  2. Changes in co-morbid anxiety scores

    Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)

    State Trait Anxiety Inventory (STAI) Scores

  3. Changes in neuropsychological variables: Attention

    Time frame: 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

  4. Changes in neuropsychological variables: Interference

    Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)

    Stroop Color-Word Test, Interference scores

  5. Changes in neuropsychological variables: Cognitive Flexibility 1

    Time frame: 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

  6. Changes in neuropsychological variables: Cognitive Flexibility 2

    Time frame: 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

  7. Changes in electrophysiological markers

    Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)

    Ln-transformed theta/beta ratio

  8. Changes in event-related potentials 1

    Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)

    Contingent Negative Variation Amplitudes

  9. Changes in event-related potentials 2

    Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)

    Emitted P 300 Amplitudes

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jun 21, 2013
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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