Efficacy of Neurofeedback Training in Adults With ADHD

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT01883765
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-21
• Primary Completion: 2015-12
• Study Completion: 2016-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in ADHD symptomatology	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universität Tübingen; 🇩🇪 Tuebingen, Baden-Württemberg, Germany