Trial document





This trial has been registered retrospectively.
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  DRKS00005445

Trial Description

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Title

Chronic Fatigue Syndrome - a randomized controlled pilot study to compare biofeedback therapy as cognitive behavioral intervention with graded exercise training concerning psychometric and physiological data in women with chronic fatigue syndrome

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Trial Acronym

BeNe

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URL of the Trial

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Brief Summary in Lay Language

Patients with chronic fatigue syndrome suffer from persistent feelings of exhaustion, reduced abitilty to cope with stress and further somatic complaints, e. g. pain. The study examines 30 patients, suffering from chronic fatigue syndrome. The patients participate either in a cognitive behavioral treatment (biofeedback therapy) or in a graded exercise treatment. We aim to assess the treatments´ effects on self efficay, fatigue, quality of life and on physiological data (cor-tisol level, cardiovascular system).

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Brief Summary in Scientific Language

Chronic fatigue syndrome (CFS), a somatoform disorder (ICD10 F48.0), has become more important over the past years. It is associated with a chronic progress, high comorbidity and high health care utilization. It is assumed that the experience of chronic bodily symptoms combined with loss of functioning is influenced by multiple biological, psychological, interpersonal, and social factors. The lack of coping strategies and anticipation of failure often causes a state of endless, increased physiological arousal in patients with CFS. This cycle might be intensified by focusing on bodily complaints, genetic polymorphisms and personality traits and might lead to a persistent state of imbalance associated with feelings of exhaustion, pain and reduced cognitive ability. Recommended therapies for CFS are cognitive behavioural therapy (CBT) and graded exercise training. Our study aims to assess 30 patients with CFS that were randomized to 8 sessions of biofeedback therapy or 8 sessions of graded exercise training after written informed consent. Primary outcome are mental and physical quality of life (physical, emotional and social role function, mental well-being, pain and vitality) and different subscales of fatigue within three measuring times (pre, post and follow-up). Furthermore different physiological data as salivary cortisol, heart rate, blood pressure and heart rate variability were measured under relaxation and stress. Endurance and individual anaerobe threshold is measured by spirometry. Patients were asked to keep diary about fatigue and exhaustion and their daily hassles. Even if biofeedback therapy is proofed to be effective in a wide range of somatoform disorders, this is, to the best of our knowledge, the first study to compare manualized biofeedback therapy in a randomized controlled approach to graded exercise training as an established intervention in CFS. We aim to analyze effectiveness of biofeedback therapy and graded exercise training on CFS including elements of education, cognitive behavioural interventions, coping strategies and reduction of resting behavior and strengthening of physical capacity.

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Organizational Data

  •   DRKS00005445
  •   2013/11/26
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  •   yes
  •   Approved
  •   310/2009BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   F48.0 -  Neurasthenia
  •   depression, quality of life
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Interventions/Observational Groups

  •   Biofeedback therapy is considered to be a specific method of cognitive behavioral therapy. It allows simultaneous feedback of physiological functions and allows patients to influence that physiological parameter in a positive way. It improves interoception and feelings of self-efficacy. In this study respiratory sinus arrhythmia (breathing, pulse frequency) was chosen as biofeedback trainings parameter. The biofeedback therapy was carried out in a manualized way by a trained clinical psychologist. Biofeedback therapy consisted of 8 individual training sessions of 50 minutes each. Patients were instructed to keep a diary to assess the intensity of fatigue, daily activities, and their individual training without device at home. The diary was discussed with patients at the beginning of each session.
  •   For graded exercise, the individual anaerobe threshold (IAS), collected by spirometry, was the individual training baseline. Patients were instructed in slow walking training adapted to their heart rate. The dura-tion and exercise intensity were set at a level that has been identified as achievable under spirometry testing and unlikely to exacerbate the patients´ symptoms. Graded exercise training consisted of 8 individual training sessions of 50 minutes each, carried out by a certified sports scientist. Patients were instructed to keep a diary to assess the intensity of fatigue, daily activities, and their individual training at home, that was controlled by a pulse watch. The diary was discussed with patients at the beginning of each session.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Fatigue (Questionnaire); pre, post, 5month-follow-up
Fatigue was measured by the “multidimensional fatigue inventory” (MFI, Gaab & Ehlert, 2005). It measures fatigue on five subscales (general fatigue, physical fatige, reduced activity, reduced motivation, mental fatigue) and allows the accumulation of a total score. MFI was assessed pre and post intervention and in a 5 month-follow-up.

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Secondary Outcome

Quality of Life, depression, stress/ability to relax (questionnaires); pre, post, 5month-follow-up.

Physiological stress reaktion (orthostatic test, salivary cortisol); pre, post.

Quality of life - that is, physical and mental functioning - was assessed by the “Short Form General Health Survey” (SF36; Bullinger & Kirchberger, 1998).
Depression was assessed using the “Patient Health Questionnaire” (PHQ-9; Löwe et al., 2002).
Ability to relax was assessed by the “Symptom Checklist for Perceived Relaxation” (ASS-Sym; Krampen 2006).
Assessment of questionnaires took place before and after intervention and at a five-month follow-up.
Physiological stress reaction was measured pre and post intervention by orthostatic test and by salivary cortisol level (8 measurements a day once before and once after intervention).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/11/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Clinically evaluated, persistent and chronic fatigue (6months or longer); four or more of the following symptoms: impaired memory or concentration, sore throat, tender cervical or axilliary lymph nodes, muscle pain, multi-joint pain, new headaches, unrefreshing sleep and post-exertion malaise.

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Exclusion Criteria

somatic or medical conditions explaining fatigue (e.g. can-cer), substance abuse, primary psychiatric disorder (e.g. schizophrenia), major depression or anxiety disorder, on-going psychotherapy or activation programme, a body-mass index (BMI) lower than 18.5kg/m² or higher than 35kg/m², and male sex]

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Addresses

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    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen
    • Mr.  Dr.  Martin  Teufel 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen
    • Ms.  Petra  Windthorst 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen
    • Ms.  Petra  Windthorst 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Tübingen Abteilung für Psychosomatische Medizin
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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    • Alfred-Teufel-Stiftung, Nagold
    • 72207  Nagold
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.