Efficacy of Neurofeedback Training in Adults With ADHD

NCT01883765 | Completed

• 1 other identifier: SCHO 1448/2-1
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, Neurofeedback, CBT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Changes in co-morbid depression 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

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

• Changes in neuropsychological variables: Attention

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

• Changes in neuropsychological variables: Interference

  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

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

Study Arms (3)

Neurofeedback active

EXPERIMENTAL

Active neurofeedback training, theta/beta-protocol

Behavioral: Neurofeedback active

Neurofeedback sham

SHAM COMPARATOR

Neurofeedback training is simulated to subjects in this condition

Behavioral: Neurofeedback active; Behavioral: Neurofeedback sham

Metacognitive Training

ACTIVE COMPARATOR

Metacognitive training, cognitive behavioral therapy

Behavioral: Metacognitive Training

Interventions

Neurofeedback active BEHAVIORAL

Neurofeedback active; Neurofeedback sham

Neurofeedback sham BEHAVIORAL

Also known as: placebo neurofeedback, simulated neurofeedback

Neurofeedback sham

Metacognitive Training BEHAVIORAL

Also known as: cognitive behavioral therapy, group therapy

Metacognitive Training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ADHD diagnosis
• sufficient knowledge of the German language

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• German Research Foundation: collaborator

Study Sites (1)

Universität Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (1)

• 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.

  PMID: 28803030 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Color Vision Defects

Interventions

Cognitive Behavioral Therapy; Psychotherapy, Group

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioenvironmental Therapy

Study Officials

• Michael Schönenberg, Dr

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

• Martin Hautzinger, Prof. Dr.

  University Hospital Tuebingen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Triple-blind Randomized Placebo-controlled Study

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: June 21, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: November 1, 2016
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

DE (1)