Evaluation of manualized neurofeedback training in inpatient psychosomatic psychotherapy treatment: a pilot clinical study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031538

Enrollment

Registered

2023-03-28

Start date

2023-05-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosomatic disorders, including affective disorders, somatoform disorders, post-traumatic stress disorders, adjustment disorders, and eating disorders.

Interventions

Group 1: The neurofeedback treatment is performed with the device Nexus 10 and the corresponding BioTrace program (Mind Media). Patients receive a total of ten sessions of neurofeedback with a trainin

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Presence of psychosomatic diagnosis, presence of informed consent

Exclusion criteria

Exclusion criteria: Neurological diseases and diseases affecting the central nervous system, current implementation of high-frequency outpatient psychotherapy, lack of language skills in German

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be theta band (4-8 Hz), alpha band (8-12 Hz), SMR band (12-15 Hz), and high-beta band (23-30 Hz) frequency bands measured at T0, T1, and T2 and during neurofeedback training sessions using electroencephalography. T0 = measurement before the start of neurofeedback training. T1 = measurement after 10 sessions of neurofeedback training T2 = measurement 2 months after the last neurofeedback session.	—

Measure

Time frame

The primary endpoint will be theta band (4-8 Hz), alpha band (8-12 Hz), SMR band (12-15 Hz), and high-beta band (23-30 Hz) frequency bands measured at T0, T1, and T2 and during neurofeedback training sessions using electroencephalography. T0 = measurement before the start of neurofeedback training. T1 = measurement after 10 sessions of neurofeedback training T2 = measurement 2 months after the last neurofeedback session.

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Secondary

Measure	Time frame
Secondary endpoints are - muscle tension, blood volume pulse, respiratory rate measured during T0, T1 and T2 - Mood and subjective stress experience (measured using self-generated items) before and after each neurofeedback session - Stress experience (measured with the PSQ), relaxation ability (measured with the RSQ), attention (derived from above EEG frequencies), self-efficacy (measured with the SWE), quality of life (measured with the WHOQOL-Bref), depressive symptoms (measured with the PHQ-8), anxious symptoms (measured with the GAD-7), insomnia (measured with the ISI) at T0, T1, and T2 - Acceptability and feasibility (measured using self-generated items), satisfaction (measured using the ZUF-8), and usefulness (measured using the SUS) at T1. In addition, employees (neurofeedback users) of the Clinic for Psychosomatic Medicine and Psychotherapy will be surveyed about the acceptance and feasibility of the neurofeedback offer during the course of the study.	—

Measure

Time frame

Secondary endpoints are - muscle tension, blood volume pulse, respiratory rate measured during T0, T1 and T2 - Mood and subjective stress experience (measured using self-generated items) before and after each neurofeedback session - Stress experience (measured with the PSQ), relaxation ability (measured with the RSQ), attention (derived from above EEG frequencies), self-efficacy (measured with the SWE), quality of life (measured with the WHOQOL-Bref), depressive symptoms (measured with the PHQ-8), anxious symptoms (measured with the GAD-7), insomnia (measured with the ISI) at T0, T1, and T2 - Acceptability and feasibility (measured using self-generated items), satisfaction (measured using the ZUF-8), and usefulness (measured using the SUS) at T1. In addition, employees (neurofeedback users) of the Clinic for Psychosomatic Medicine and Psychotherapy will be surveyed about the acceptance and feasibility of the neurofeedback offer during the course of the study.

—

Countries

Germany

Contacts

Public ContactKira Schmidt

LVR-Universitätsklinik Essen, Klinik für Psychosomatische Medizin und Psychotherapie

kira.schmidt@lvr.de0201 438755 221

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026