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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

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 - BeNe

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00005445
Enrollment
30
Registered
2013-11-26
Start date
2009-11-01
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

depression, quality of life F48.0

Interventions

Group 1: 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 phy

Sponsors

Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

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

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]

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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).

Countries

Germany

Contacts

Public ContactPetra Windthorst

Universitätsklinikum Tübingen

petra.windthorst@med.uni-tuebingen.de07071-29-86719

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 11, 2026