Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue

Chronic Fatigue Syndrome Clinical Trial

Official title:

Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00983502
• Other study ID #: 25988
• Secondary ID: R21AT004537-02
• Status: Terminated
• Phase: N/A
• First received: September 22, 2009
• Last updated: December 13, 2011
• Start date: August 2008
• Est. completion date: October 2010

Study information

• Verified date: December 2011
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 154
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Encephalomyelitis
• Fatigue
• Fatigue Syndrome, Chronic
• Idiopathic Chronic Fatigue
• Myalgic Encephalomyelitis

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences among four groups of clinicians with respect to patient treatment outcome		Six months	No