Trial document




drksid header

  DRKS00011668

Trial Description

start of 1:1-Block title

Title

Biofeedback and Self-Management

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

BSM

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The study aims to provide insights into the indication and efficacy of a short to medium-term biofeedback intervention in psychiatrically disturbed patients.

Biofeedback is a scientific method of behavioral medicine that allows for psychophysiological processes such as breathing patterns (respiratory rate, respiratory amplitude), blood pressure, pulse (frequency, amplitude and variability), oxygen content of the blood, body temperature, dermal resistance or muscle potentials by feedback (visual or acoustic feedback).

Scientific literature provides evidence that not only physical processes can be selectively influenced by means of biofeedback training but that the training also leads to a reduction of associated symptoms (for example, anxiety disorders, psychosomatic or somatoform disorders, pain, depression). Also, an effect on mental abilities such as self-awareness has been observed.

Biofeedback training is generally expected to have a positive effect on a person's self-awareness, self-perception and self-control ability (see Kröner-Herwig and Sachse, 1981). Hence, biofeedback-intervention is considered to be beneficial to the patient's health, especially to patients demonstrating reduced self-awareness. It is expected that biofeedback therapy improves body perception, irrespective of the diagnosed mental disorder, by regular concentration on subliminal (below threshold/unconscious) physical processes and also leads to an improved general controllability of physical or emotional processes.

In this context, it is to be examined whether the habituated (habituation is a form of learning which leads to a decrease or the cessation in responding to a certain stimulus after repeated presentations) self-awareness (as a person's personality) can already be used as an indicator feature for a biofeedback treatment.

The aim is to determine which groups of people are more likely to benefit from such training: patients with an already pronounced tendency to focus their perception on their own (physical / emotional) processes or patients with a low tendency to focus perception on internal processes.

Secondly, it is to be examined which parameters best represent a biofeedback treatment outcome. This can be influenced by the characteristic values which are determined by the direct effects of biofeedback training (physiological and cognitive measures as well as dispositional variables).

Thirdly, it is to be examined which general variables of the emotional action control /self-regulation show an (mediating) impact on the success of regular biofeedback treatment.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language





The study deals with the analysis of predictors for a successful biofeedback treatment with special regard to dispositional self-awareness.


A biofeedback short-term intervention is to be carried out in a heterogeneous sample with regard to the clinical disturbance pattern. Outcomes are determined by psycho-physiological parameters and self-report measures (inter alia, BHI-2, German version, FERUS). The goal is the analysis of individual reaction patterns and the development of a treatment indication profile for Biofeedback.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011668
  •   2017/02/09
  •   [---]*
  •   yes
  •   Approved
  •   17-01-25, Ethikkommission am Institut für Psychologie der Universität Bonn, Kaiser-Karl-Ring 9, 53111 Bonn Tel.: +49 228 73-4387 Fax: +49 228 73-62321
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F41.0 -  Panic disorder [episodic paroxysmal anxiety]
  •   F41.2 -  Mixed anxiety and depressive disorder
  •   F41.3 -  Other mixed anxiety disorders
  •   F41.9 -  Anxiety disorder, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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 means of a graphical representation of selected target parameters. All of the derived signals are considered target parameters (skin conductance, EMG measurements, temperature, respiration, heart rate, blood volume pulse). The selected target parameter, for example respiration, is displayed graphically (in real time) on the patient screen so that the patient can see his respiratory pattern and actively influence the same in order to get a feel for his / her own body processes and their controllability. In addition to the graphic representation, biofeedback is carried out by means of animations (moving pictures, for example waves on the beach) in interaction with an automatic threshold. This threshold ensures that the moving image freezes as soon as the physical processes of the patient feed back tension. The patient is instructed to restore relaxation so that the image moves further.

    Regarding the measurements:
    Skin Conductance (EDA): The current is measured by the non-sensible but constant voltage between two electrodes located at two different fingertips of the non-dominant hand of the Patient.

    EMG: For the EMG frontalis measurement, sensors are applied to the Musculus zygomaticus major, the Musculus corrugator supercilii and the Musculus levator labii muscle.

    Temperature: The temperature is measured by means of a finger sensor (thermistor) placed on the uppermost limb of a finger.

    Respiration: As a measurement sensor, a stretch-sensitive breathing belt is placed above the navel.

    Blood volume pulse: The blood volume pulse is measured by means of a finger sensor (a staple) located at the first finger of the patient's non-dominant hand.

    Heart rate: The heart rate is derived using the stretch-sensitive breathing belt.


    1. Session: psychoeducation, knowledge transfer and demonstration of the apparatus and procedure; Questionnaires: Battery of Health Improvement 2 (Bruns & Disorbio, German version Dohrenbusch & Backhaus), Fragebogen zur dispositionellen Selbstaufmerksamkeit (Filipp & Freudenberg,
    1989) (a questionnaire which aims at determining dispositional self-awareness), FERUS Fragebogen zur Erfassung von Ressourcen und Selbstmanagementfähigkeiten
    (Jack, 2007) (a questionnaire which aims at determining ressources and self-management skills), Basler Befindlichkeitsskala (Hobi, 1995); Documentation of subjective perception; Documentation of parallel therapeutic and / or rehabilitative activities

    2. Session: Creation of a psychophysiological stress profile with the following sequences:

    1. Adaptation phase / Baseline (patient sitting with eyes open) 2. Relaxation I: spontaneous, without help 3. Stressor I: Performance stress: arithmetic task 4. Self control phase I: without instruction 5. Stressor II: Social stress: sing a song 6. Self-control phase II: without instruction 7. Stressor III: individual stress: report a current stress of every day life 8. Self-control phase II: without instruction 9. Fade-out phase;

    Questionnaire: Basler Befindlichkeitsskala; Documentation of subjective perception; Documentation of parallel therapeutic and / or rehabilitative activities

    Session 3 to 6:
    1. Adaptation phase / Baseline (Patient sitting with eyes open) 2. Observation and experimentation: graph of the derived target parameter - in sessions 3 to 6, the focus will be on differing target parameters (skin conductance, EMG measurements, temperature, respiration, heart rate, blood volume pulse) since only one parameter per session is presented to the patient visually, albeit all measurements are derived during all sessions. The selected target parameter, for example respiration, is graphically displayed on the patient screen so that the patient can see his respiratory pattern and actively influence it in order to get a feeling for his / her own body processes and their controllability 3. Visual feedback with Animation - In this step the graphic feedback is replaced by an animation. The patient should enjoy the monotony of the movement to deepen the relaxation 4. Visual feedback with animation and threshold: The animation is linked to an automatic threshold. As soon as the biosignals of the patient indicate signs of tension, the movement freezes. Now the patient is encouraged to develop strategies for restoring relaxation and, consequently, the movement of the animated image. 5. Stressor (performance stress / individual stress / social stress) 6. Self-control phase: spontaneous relaxation, without instruction 7. Visual feedback with a graph of the derived target parameter (see 2.), the selected target parameter is presented again graphically as feedback to the patient (for example, the patient will notice that a relaxed abdominal breathing pattern characterized by <12 breaths / minute appears as a result of the training) 8. Stressor 9. Self-control phase: spontaneous relaxation without instruction 10. Relaxation picture and audio (without threshold) - a picture with which the patient has a positive association (for example a beach) is presented visually. The Picture is accompanied by relaxation music to initiate the imagination exercise 11. Induced relaxation (imagination exercise: guided imagery program) 12. Fade-out phase;

    Questionnaire: Basler Befindlichkeitsskala; Documentation of subjective perception; Documentation of parallel therapeutic and / or rehabilitative activities

    7. Session: Psychophysiological stress profile for a pre-post comparison and questionnaires: Battery of Health Improvement 2 (Bruns & Disorbio, German version Dohrenbusch & Backhaus), Fragebogen zur dispositionellen Selbstaufmerksamkeit (Filipp & Freudenberg,
    1989) (a questionnaire which aims at determining dispositional self-awareness), FERUS Fragebogen zur Erfassung von Ressourcen und Selbstmanagementfähigkeiten
    (Jack, 2007) (a questionnaire which aims at determining ressources and self-management skills), Basler Befindlichkeitsskala (Hobi, 1995) Documentation of subjective perception; Documentation of parallel therapeutic and / or rehabilitative activities
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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 skills)
d) Documentation of parallel therapeutic and / or rehabilitative activities

Before each single session:
Short exploration of self-regulatory activities in everyday life since the last session.

Before and after each individual session:
Sensitivity scale (Basler Befindlichkeitsskala, BBS (Hobi, 1995))

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Modification of primary target parameters in the context of routinely performed standard therapy.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2017/02/15
  •   80
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   55   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Exclusion of patients with psychoses or delusional disorders.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Rheinische Friedrich-Wilhelms-UniversitätInstitut für PsychologieAbteilung für Methodenlehre, Diagnostik und Evaluation
    • Mr.  PD Dr.  Ralf  Dohrenbusch 
    • Kaiser-Karl-Ring 9
    • 53111  Bonn
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • LVR Klinik Bonn
    • Ms.  Karoline  Klingemann 
    • Kaiser-Karl-Ring 20
    • 53111  Bonn
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Rheinische Friedrich-Wilhelms-Universität BonnInstitut für PsychologieAbteilung für Methodenlehre, Diagnostik und Evaluation
    • Ms.  M.A.  Christina  Huylmans 
    • Kaiser-Karl-Ring 9
    • 53111  Bonn
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Rheinische Friedrich-Wilhelms-UniversitätInstitut für PsychologieAbteilung für Methodenlehre, Diagnostik und Evaluation
    • Mr.  Dr.  Ralf  Dohrenbusch 
    • Kaiser-Karl-Ring 9
    • 53111  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • LVR Klinik Bonn
    • Ms.  Karoline  Klingemann 
    • Kaiser-Karl-Ring 20
    • 53111  BONN
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.