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Efficacy of Neurofeedback Training in Adults With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Neurofeedback active
Neurofeedback sham
Metacognitive Training
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Neurofeedback, CBT

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universität Tübingen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Neurofeedback active

Neurofeedback sham

Metacognitive Training

Arm Description

Active neurofeedback training, theta/beta-protocol

Neurofeedback training is simulated to subjects in this condition

Metacognitive training, cognitive behavioral therapy

Outcomes

Primary Outcome Measures

Changes in ADHD symptomatology
Conners' Adult ADHD Rating Scale (CAARS) Scores

Secondary Outcome Measures

Changes in co-morbid depression scores
Beck Depression Inventory (BDI) Scores
Changes in co-morbid anxiety scores
State Trait Anxiety Inventory (STAI) Scores
Changes in neuropsychological variables: Attention
Continuous Performance Test (CPT), Errors in Omission and Errors in Commission
Changes in neuropsychological variables: Interference
Stroop Color-Word Test, Interference scores
Changes in neuropsychological variables: Cognitive Flexibility 1
Test for Attentional Performance (TAP) - Flexibility, RT in ms and Errors
Changes in neuropsychological variables: Cognitive Flexibility 2
Inventory for Complex Attention (INKA), Items correctly performed
Changes in electrophysiological markers
Ln-transformed theta/beta ratio
Changes in event-related potentials 1
Contingent Negative Variation Amplitudes
Changes in event-related potentials 2
Emitted P 300 Amplitudes

Full Information

First Posted
February 21, 2013
Last Updated
March 8, 2017
Sponsor
University Hospital Tuebingen
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01883765
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
Collaborators
German Research Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Neurofeedback, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurofeedback active
Arm Type
Experimental
Arm Description
Active neurofeedback training, theta/beta-protocol
Arm Title
Neurofeedback sham
Arm Type
Sham Comparator
Arm Description
Neurofeedback training is simulated to subjects in this condition
Arm Title
Metacognitive Training
Arm Type
Active Comparator
Arm Description
Metacognitive training, cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback active
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback sham
Other Intervention Name(s)
placebo neurofeedback, simulated neurofeedback
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive Training
Other Intervention Name(s)
cognitive behavioral therapy, group therapy
Primary Outcome Measure Information:
Title
Changes in ADHD symptomatology
Description
Conners' Adult ADHD Rating Scale (CAARS) Scores
Time Frame
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Secondary Outcome Measure Information:
Title
Changes in co-morbid depression scores
Description
Beck Depression Inventory (BDI) Scores
Time Frame
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Title
Changes in co-morbid anxiety scores
Description
State Trait Anxiety Inventory (STAI) Scores
Time Frame
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Title
Changes in neuropsychological variables: Attention
Description
Continuous Performance Test (CPT), Errors in Omission and Errors in Commission
Time Frame
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Title
Changes in neuropsychological variables: Interference
Description
Stroop Color-Word Test, Interference scores
Time Frame
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Title
Changes in neuropsychological variables: Cognitive Flexibility 1
Description
Test for Attentional Performance (TAP) - Flexibility, RT in ms and Errors
Time Frame
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Title
Changes in neuropsychological variables: Cognitive Flexibility 2
Description
Inventory for Complex Attention (INKA), Items correctly performed
Time Frame
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Title
Changes in electrophysiological markers
Description
Ln-transformed theta/beta ratio
Time Frame
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Title
Changes in event-related potentials 1
Description
Contingent Negative Variation Amplitudes
Time Frame
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Title
Changes in event-related potentials 2
Description
Emitted P 300 Amplitudes
Time Frame
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Schönenberg, Dr
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Hautzinger, Prof. Dr.
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Study Chair
Facility Information:
Facility Name
Universität Tübingen
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28803030
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.
Results Reference
derived

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Efficacy of Neurofeedback Training in Adults With ADHD

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