Informations générales
  • Catégorie de maladie Troubles mentaux et du comportement (BASEC)
  • État du recrutement recrutement pas encore commencé (BASEC/ICTRP)
  • Lieu de l’étude
    Autre
    (BASEC)
  • Responsable de l'étude Patrick Köck patrick.koeck@barmelweid.ch (BASEC)
  • Source(s) de données BASEC: Importé de 30.07.2025 ICTRP: N/A
  • Date de mise à jour 30.07.2025 08:50
HumRes67078 | SNCTP000006487 | BASEC2025-01026

Improvement of Emotion Regulation in Young Adults through Neurofeedback Training: An Adjunct Approach to Inpatient Multimodal Psychotherapy – A Feasibility Study

  • Catégorie de maladie Troubles mentaux et du comportement (BASEC)
  • État du recrutement recrutement pas encore commencé (BASEC/ICTRP)
  • Lieu de l’étude
    Autre
    (BASEC)
  • Responsable de l'étude Patrick Köck patrick.koeck@barmelweid.ch (BASEC)
  • Source(s) de données BASEC: Importé de 30.07.2025 ICTRP: N/A
  • Date de mise à jour 30.07.2025 08:50

Résumé de l'étude

Difficulties in regulating emotions are common among young adults. When one has problems with emotion regulation, they typically experience strong mood swings, intense negative emotions, and sometimes dissociative symptoms (such as feeling unreal or detached). These issues are usually treated with psychotherapeutic conversations. There is already research on treating difficulties in emotion regulation. Previous studies have shown that psychotherapeutic approaches can be effective. However, we do not yet know enough about whether additional non-verbal treatment methods like neurofeedback can help. Therefore, in this study, we investigate whether neurofeedback training is effective as an adjunct method in treating difficulties in emotion regulation. Neurofeedback is a procedure where you can see your own brain activity on a screen and learn to control it. The device we use (NeXus-10 MKII with BioTrace+ software) is approved as a medical device in Switzerland. The results of this study aim to show whether neurofeedback training is helpful in addition to standard treatment and can lead to an improvement in emotion regulation and a reduction in dissociative symptoms. In our study, participants are randomly assigned to groups. This is important to obtain reliable results from the study, a process known as randomization. Each group receives a different treatment. In our study, there are 2 groups: • Group 1 (experimental group) receives standard treatment plus neurofeedback training three times a week. • Group 2 (control group) receives the standard treatment from the Barmelweid Clinic. The study is an open-label study. This means that both you and the investigators know which group you belong to.

(BASEC)

Intervention étudiée

The intervention consists of EEG-based NFB training offered as an adjunct therapy alongside standard treatment (TAU). Using the NeXus-10 MKII device and BioTrace+ software, participants take part in 18 supervised training sessions over a period of 6 weeks, occurring three times a week (e.g., Monday-Wednesday-Friday). Each session begins with a 3-minute baseline recording with eyes open, followed by a 20-minute alpha amplitude downregulation protocol targeting the 8-12 Hz activity measured at position Pz. The training period is structured into seven blocks (six 3-minute periods and one 2-minute period), during which participants receive visual feedback through an engaging/entertaining interface (such as watching a movie or TV series).

In the NFB sessions for this study, participants wear a single EEG electrode at position Pz (middle parietal region) while watching a video of their choice. This video serves as a feedback mechanism: when the alpha wave activity (8-12 Hz) remains below a personalized threshold, the video plays normally in full size and brightness; when the alpha activity exceeds the threshold, the video automatically becomes smaller and darker. It is believed that this creates an implicit learning process where the brain naturally works to maintain the rewarding state (seeing the clear, full-sized video) by keeping the alpha activity reduced. Participants simply relax and watch the video during the seven short training blocks (six 3-minute periods and one 2-minute period), allowing their brain to learn this self-regulation process without requiring conscious effort or specific mental strategies.

(BASEC)

Maladie en cours d'investigation

Emotion regulation disorders, dissociation

(BASEC)

Critères de participation
- Aged between 18 and 30 years - Patients in inpatient psychotherapy at the Barmelweid Clinic - DERS-16 score equal to or greater than 34 points (BASEC)

Critères d'exclusion
- Diagnosis of schizophrenia or bipolar disorder - History of epilepsy or cerebral seizures - Body Mass Index below 15 kg/m2 (BASEC)

Lieu de l’étude

Autre

(BASEC)

5017 Barmelweid/Erlinsbach

(BASEC)

non disponible

Sponsor

Klinik Barmelweid AG

(BASEC)

Contact pour plus d'informations sur l'étude

Personne de contact en Suisse

Patrick Köck

+41 (0) 62 857 20 29

patrick.koeck@barmelweid.ch

Klinik Barmelweid AG

(BASEC)

Informations scientifiques

non disponible

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

(BASEC)

Date d'approbation du comité d'éthique

16.07.2025

(BASEC)


Identifiant de l'essai ICTRP
non disponible

Titre officiel (approuvé par le comité d'éthique)
Enhancing Emotion Regulation in Youth through Neurofeedback Training: An Adjunctive Approach to Standard In-Patient Multimodal Psychotherapy - a Pilot Study (BASEC)

Titre académique
non disponible

Titre public
non disponible

Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai

Résumé des résultats

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Lien vers les résultats dans le registre primaire

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