Efficacy of Neurofeedback Training in Adults With ADHD

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: Neurofeedback active; Behavioral: Neurofeedback sham; Behavioral: Metacognitive Training

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Tuebingen, Baden-Württemberg, Germany, 72076
      • Universitat Tubingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: placebo neurofeedback, simulated neurofeedback
Active Comparator: Metacognitive Training; Metacognitive training, cognitive behavioral therapy	Behavioral: Metacognitive Training; Other Names: cognitive behavioral therapy, group therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in ADHD symptomatology	Conners' Adult ADHD Rating Scale (CAARS) Scores	pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in co-morbid depression scores	Beck Depression Inventory (BDI) Scores	pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in co-morbid anxiety scores	State Trait Anxiety Inventory (STAI) Scores	pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in neuropsychological variables: Attention	Continuous Performance Test (CPT), Errors in Omission and Errors in Commission	pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in neuropsychological variables: Interference	Stroop Color-Word Test, Interference scores	pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in neuropsychological variables: Cognitive Flexibility 1	Test for Attentional Performance (TAP) - Flexibility, RT in ms and Errors	pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in neuropsychological variables: Cognitive Flexibility 2	Inventory for Complex Attention (INKA), Items correctly performed	pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in electrophysiological markers	Ln-transformed theta/beta ratio	pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in event-related potentials 1	Contingent Negative Variation Amplitudes	pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Changes in event-related potentials 2	Emitted P 300 Amplitudes	pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: German Research Foundation
• Investigators: Principal Investigator: Michael Schönenberg, Dr, University Hospital Tuebingen; Study Chair: Martin Hautzinger, Prof. Dr., University Hospital Tuebingen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: February 21, 2013
• First Submitted That Met QC Criteria: June 18, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: ADHD, Neurofeedback, CBT
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: SCHO 1448/2-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED