Biofeedback and Self-Management

Biofeedback and Self-Management - BSM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011668

Enrollment

Registered

2017-02-09

Start date

2017-02-15

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

F41.0 F41.2 F41.3 F41.9

Interventions

Group 1: In the context of the planned study, a biofeedback short-term intervention of 7 sessions will be conducted. Biofeedback, i.e. the feedback of biological (physical) signals, is carried out by

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: In total 80 patients (male / female, between 18 and 55 years of age) with mental disorders in inpatient treatment will be recruited. The designated study does not focus on a specific patient group or diagnose, but on mental or emotional self-regulation processes which can be influenced by biofeedback.

Exclusion criteria

Exclusion criteria: Exclusion of patients with psychoses or delusional disorders.

Design outcomes

Primary

Measure	Time frame
Peripheral biofeedback as short-term intervention over 7 sessions (non-invasive). Derivation of the following physiological measures: Skin conductance, EMG measurements, temperature, breathing, heart rate, blood volume pulse The following procedures are to be used for status and change measurement: - Measures of the physiological tension level (EMG difference values, increase in skin resistance, decrease in heart rate, etc.) as indicators of a biofeedback-induced relaxation state - Process measurements of the biofeedback apparatus, which inform about the patient's ability to control physical processes by means of targeted / conscious regulation. - Changes in the subjective condition during the biofeedback session. For this purpose, the patients should perform a brief, standardized assessment of the mood based on the Basler Befindlichkeitsskala (Hobi, 1995) (sensitivity scale) before and after each session - Outcome variables: Before and after the whole treatment, patients will be asked to complete the German version of the Battery of Health Improvement (BHI-2). With reference to existing studies, the following BHI-2 scales can be used as potential measures for reflecting a biofeedback treatment success: muscle tension, somatic symptoms, depression, anxiety, hostility, symptom dependency, substance abusus, doctor discontent. Biofeedback training will be conducted in 6 sessions, each of which will last approximately 30 minutes. Before and after the whole treatment the following questionnaires will be completed by the participants: a) Battery of Health Improvement 2 (Bruns & Disorbio) German version in preparation (Dohrenbusch & Brockhaus) b) Fragebogen zur dispositionellen Selbstaufmerksamkeit (Filipp & Freudenberg, 1989) (a questionnaire which aims at determining dispositional self-awareness) c) FERUS Fragebogen zur Erfassung von Ressourcen und Selbstmanagementfähigkeiten (Jack, 2007) (a questionnaire which aims at determining ressources and self-management sk	—

Measure

Time frame

Peripheral biofeedback as short-term intervention over 7 sessions (non-invasive). Derivation of the following physiological measures: Skin conductance, EMG measurements, temperature, breathing, heart rate, blood volume pulse The following procedures are to be used for status and change measurement: - Measures of the physiological tension level (EMG difference values, increase in skin resistance, decrease in heart rate, etc.) as indicators of a biofeedback-induced relaxation state - Process measurements of the biofeedback apparatus, which inform about the patient's ability to control physical processes by means of targeted / conscious regulation. - Changes in the subjective condition during the biofeedback session. For this purpose, the patients should perform a brief, standardized assessment of the mood based on the Basler Befindlichkeitsskala (Hobi, 1995) (sensitivity scale) before and after each session - Outcome variables: Before and after the whole treatment, patients will be asked to complete the German version of the Battery of Health Improvement (BHI-2). With reference to existing studies, the following BHI-2 scales can be used as potential measures for reflecting a biofeedback treatment success: muscle tension, somatic symptoms, depression, anxiety, hostility, symptom dependency, substance abusus, doctor discontent. Biofeedback training will be conducted in 6 sessions, each of which will last approximately 30 minutes. Before and after the whole treatment the following questionnaires will be completed by the participants: a) Battery of Health Improvement 2 (Bruns & Disorbio) German version in preparation (Dohrenbusch & Brockhaus) b) Fragebogen zur dispositionellen Selbstaufmerksamkeit (Filipp & Freudenberg, 1989) (a questionnaire which aims at determining dispositional self-awareness) c) FERUS Fragebogen zur Erfassung von Ressourcen und Selbstmanagementfähigkeiten (Jack, 2007) (a questionnaire which aims at determining ressources and self-management sk

—

Secondary

Measure	Time frame
Modification of primary target parameters in the context of routinely performed standard therapy.	—

Countries

Germany

Contacts

Public ContactChristina Huylmans

Rheinische Friedrich-Wilhelms-Universität BonnInstitut für PsychologieAbteilung für Methodenlehre, Diagnostik und Evaluation

s5chhuyl@uni-bonn.de01727970258

Outcome results

None listed

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