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

Not Applicable

Conditions: depression, quality of life
F48.0
Neurasthenia

Registration Number: DRKS00005445

Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 28

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.

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]

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue (Questionnaire); pre, post, 5month-follow-up<br>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. <br>

Secondary Outcome Measures

Name	Time	Method
Quality of Life, depression, stress/ability to relax (questionnaires); pre, post, 5month-follow-up.<br><br>Physiological stress reaktion (orthostatic test, salivary cortisol); pre, post.<br><br>Quality of life - that is, physical and mental functioning - was assessed by the Short Form General Health Survey” (SF36; Bullinger & Kirchberger, 1998).<br>Depression was assessed using the Patient Health Questionnaire” (PHQ-9; Löwe et al., 2002).<br>Ability to relax was assessed by the Symptom Checklist for Perceived Relaxation” (ASS-Sym; Krampen 2006).<br>Assessment of questionnaires took place before and after intervention and at a five-month follow-up.<br>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). <br>