Clinical trial NCT00983502: Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue
Official title: Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Idiopathic Chronic Fatigue
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Keywords: Idiopathic Chronic Fatigue
Chronic Fatigue Syndrome
Myalgic encephalomyelitis
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2009-09-24
Enrollment: 154
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The primary analyses will compare outcomes for 240 patients in four main groups (60 in each group) defined by the background of the treating clinicians. Study subjects will be UCF patients new to the practice of one of four groups of participating clinicians.

Brief summary: The investigators' long-term goal is to identify, and then provide general practitioners with evidence-based recommendations for therapeutic interventions for unexplained chronic fatigue (UCF). The investigators' central hypothesis guiding this application is that some complimentary and alternative medicine (CAM) practitioners have developed management approaches that are more helpful to patients with UCF than usual care.

Detailed description: An objective is to identify certain types of clinicians (or individual physicians) who appear to have identified effective treatments for patients with UCF, or to find that clinicians who report themselves to be effective are not. Study subjects will be UCF patients new to the practice of one of four groups of participating clinicians: 1) a control group of MDs in practice-based research networks, 2) MDs trained in CAM, 3) naturopathic doctors (non MDs trained in special naturopathic schools), and 4) MDs who specialize in chronic fatigue. Our rationale for this comparison is that its successful completion will potentially guide future searches for effective medical strategies for the treatment of UCF that may have been developed outside the mainstream medical community. It may also provide necessary information for follow-up studies that will help to identify specific effective treatments. This information includes which clinicians provide the best treatments (as evidenced by having patients with the best results), what are the characteristics of patients who respond to a particular treatment, how the data collection procedures might need to be refined and what sample sizes are necessary.

Eligibility criteria: Inclusion Criteria:

1. Age 21 through 65.
2. Has severe debilitating fatigue that substantially reduces the quality of life.
3. Does not have any organic, psychological, or lifestyle problems that are the primary disorder and are likely to be the cause of this fatigue (see exclusionary criteria)
4. The severe, unexplained fatigue has persisted for at least six months.
5. Has not been previously treated by current physician for chronic fatigue.
6. Can speak and read English.
7. Is not pregnant or planning to become pregnant within six months.
8. Has a telephone.

Exclusion Criteria:

No known history of:

1. Bipolar disorder
2. Psychosis
3. Major Depressive Disorder
4. Sleep disorder
5. Anemia
6. Thyroid disease
7. Rheumatoid Arthritis
8. Systemic Lupus
9. Cancer
10. Heart disease
11. Liver disease

Primary outcomes:
measure: Differences among four groups of clinicians with respect to patient treatment outcome
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Arthur J Hartz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: