Efficacy of Neurofeedback Training in Adults With ADHD

NCT ID: NCT01883765

Last Updated: 2017-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Neurofeedback active

Active neurofeedback training, theta/beta-protocol

Group Type EXPERIMENTAL

Neurofeedback active

Intervention Type BEHAVIORAL

Neurofeedback sham

Neurofeedback training is simulated to subjects in this condition

Group Type SHAM_COMPARATOR

Neurofeedback active

Intervention Type BEHAVIORAL

Neurofeedback sham

Intervention Type BEHAVIORAL

Metacognitive Training

Metacognitive training, cognitive behavioral therapy

Group Type ACTIVE_COMPARATOR

Metacognitive Training

Intervention Type BEHAVIORAL

Interventions

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Neurofeedback active

Intervention Type BEHAVIORAL

Neurofeedback sham

Intervention Type BEHAVIORAL

Metacognitive Training

Intervention Type BEHAVIORAL

Other Intervention Names

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placebo neurofeedback, simulated neurofeedback cognitive behavioral therapy, group therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Dr. Michael Schoenenberg

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Schönenberg, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Martin Hautzinger, Prof. Dr.

Role: STUDY_CHAIR

University Hospital Tuebingen

Locations

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Universität Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 28803030 (View on PubMed)

Other Identifiers

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SCHO 1448/2-1

Identifier Type: -

Identifier Source: org_study_id

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