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Trial record 15 of 155 for:    neurofeedback

Efficacy of Neurofeedback Training in Adults With ADHD

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ClinicalTrials.gov Identifier: NCT01883765
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Dr. Michael Schoenenberg, University Hospital Tuebingen

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.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: Neurofeedback active Behavioral: Neurofeedback sham Behavioral: Metacognitive Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Triple-blind Randomized Placebo-controlled Study
Study Start Date : February 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: Neurofeedback active
Active neurofeedback training, theta/beta-protocol
Behavioral: Neurofeedback active
Sham Comparator: Neurofeedback sham
Neurofeedback training is simulated to subjects in this condition
Behavioral: Neurofeedback active
Behavioral: Neurofeedback sham
Other Name: placebo neurofeedback, simulated neurofeedback

Active Comparator: Metacognitive Training
Metacognitive training, cognitive behavioral therapy
Behavioral: Metacognitive Training
Other Name: cognitive behavioral therapy, group therapy




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883765


Locations
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Germany
Universität Tübingen
Tuebingen, Baden-Württemberg, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
German Research Foundation
Investigators
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Principal Investigator: Michael Schönenberg, Dr University Hospital Tuebingen
Study Chair: Martin Hautzinger, Prof. Dr. University Hospital Tuebingen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Michael Schoenenberg, Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Triple-blind Randomized Placebo-controlled Study, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01883765     History of Changes
Other Study ID Numbers: SCHO 1448/2-1
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Michael Schoenenberg, University Hospital Tuebingen:
ADHD, Neurofeedback, CBT

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders