Attention Deficit Hyperactivity DisorderNCT01883765
Efficacy of Neurofeedback Training in Adults With ADHD
A study testing Neurofeedback active and Metacognitive Training in people with Attention Deficit Hyperactivity Disorder, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Neurofeedback active and Metacognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ADHD diagnosis
- sufficient knowledge of the German language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Neurofeedback active, Neurofeedback sham, Metacognitive Training
- Keywords
- ADHD, Neurofeedback, CBT
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback activeBehavioural
Neurofeedback shamBehavioural
Also called placebo neurofeedback, simulated neurofeedback
Metacognitive TrainingBehavioural
Also called cognitive behavioral therapy, group therapy
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback active | Experimental | Active neurofeedback training, theta/beta-protocol Receives: Behavioral: Neurofeedback active |
| Neurofeedback sham | Sham comparator | Neurofeedback training is simulated to subjects in this condition Receives: Behavioral: Neurofeedback active; Behavioral: Neurofeedback sham |
| Metacognitive Training | Active comparator | Metacognitive training, cognitive behavioral therapy Receives: Behavioral: Metacognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ADHD symptomatology
Conners' Adult ADHD Rating Scale (CAARS) Scores
Measured: 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
Beck Depression Inventory (BDI) Scores
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Dr. Michael Schoenenberg, University Hospital Tuebingen
- Investigators
- Michael Schönenberg, Dr, Principal investigator, University Hospital TuebingenMartin Hautzinger, Prof. Dr., Study chair, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883765
- Sponsor's protocol ID
- SCHO 1448/2-1
- Status last verified
- Mar 2017
- First submitted
- 21 Feb 2013
- Last updated
- 13 Mar 2017
- Results posted
- No
- Individual data sharing
- Undecided
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.
PubMed 28803030
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Triple-blind Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01883765
- Acronym / sponsor ID
- SCHO 1448/2-1
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Neurofeedback, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback active | Experimental | Behavioral: Neurofeedback activeActive neurofeedback training, theta/beta-protocol |
| Neurofeedback sham | Sham comparator | Behavioral: Neurofeedback active, Behavioral: Neurofeedback shamNeurofeedback training is simulated to subjects in this condition |
| Metacognitive Training | Active comparator | Behavioral: Metacognitive TrainingMetacognitive training, cognitive behavioral therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ADHD diagnosis
- sufficient knowledge of the German language
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback active | Behavioural | Neurofeedback active, Neurofeedback sham |
| Neurofeedback shamAlso: placebo neurofeedback, simulated neurofeedback | Behavioural | Neurofeedback sham |
| Metacognitive TrainingAlso: cognitive behavioral therapy, group therapy | Behavioural | Metacognitive Training |
Primary outcome
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
9 secondary outcomes
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)
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)
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)
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)
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)
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)
Changes in electrophysiological markers
Time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Derived from this study: PubMed 28803030Schonenberg 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.
- Individual participant dataSharing planned: Undecided
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Schönenberg, Dr principal investigator
University Hospital Tuebingen
Martin Hautzinger, Prof. Dr. study chair
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback active and Metacognitive Training in people with Attention Deficit Hyperactivity Disorder, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ADHD symptomatology (time frame: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01883765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.