Efficacy of Neurofeedback Training in Adults With ADHD
8 mars 2017 uppdaterad av: Dr. Michael Schoenenberg, University Hospital Tuebingen
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
118
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Baden-Württemberg
-
Tuebingen, Baden-Württemberg, Tyskland, 72076
- Universitat Tubingen
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 60 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Neurofeedback active
Active neurofeedback training, theta/beta-protocol
|
|
|
Sham Comparator: Neurofeedback sham
Neurofeedback training is simulated to subjects in this condition
|
Andra namn:
|
|
Aktiv komparator: Metacognitive Training
Metacognitive training, cognitive behavioral therapy
|
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in ADHD symptomatology
Tidsram: 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
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in co-morbid depression scores
Tidsram: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
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
Tidsram: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
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
Tidsram: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
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
Tidsram: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
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
Tidsram: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
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
Tidsram: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
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
Tidsram: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
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
Tidsram: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
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
Tidsram: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Emitted P 300 Amplitudes
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Michael Schönenberg, Dr, University Hospital Tuebingen
- Studiestol: Martin Hautzinger, Prof. Dr., University Hospital Tuebingen
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2013
Primärt slutförande (Faktisk)
1 december 2015
Avslutad studie (Faktisk)
1 november 2016
Studieregistreringsdatum
Först inskickad
21 februari 2013
Först inskickad som uppfyllde QC-kriterierna
18 juni 2013
Första postat (Uppskatta)
21 juni 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 mars 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 mars 2017
Senast verifierad
1 mars 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SCHO 1448/2-1
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .