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

Not Applicable

Recruiting

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

• Registration Number: DRKS00031538
• Lead Sponsor: VR-Universitätsklinik Essen, Klinik für Psychosomatische Medizin und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Presence of psychosomatic diagnosis, presence of informed consent

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>T0 = measurement before the start of neurofeedback training.<br>T1 = measurement after 10 sessions of neurofeedback training<br>T2 = measurement 2 months after the last neurofeedback session.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are <br>- muscle tension, blood volume pulse, respiratory rate measured during T0, T1 and T2<br>- Mood and subjective stress experience (measured using self-generated items) before and after each neurofeedback session<br>- 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<br>- Acceptability and feasibility (measured using self-generated items), satisfaction (measured using the ZUF-8), and usefulness (measured using the SUS) at T1.<br><br>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.