Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue

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Brief Title

Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue

Official Title

Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue

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.
    


Study Type

Observational


Primary Outcome

Differences among four groups of clinicians with respect to patient treatment outcome


Condition

Idiopathic Chronic Fatigue


Study Arms / Comparison Groups

 Integrative Medicine
Description:  Patients of MD practitioners trained in Complementary and Alternative Medicine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

154

Start Date

August 2008

Completion Date

October 2010

Primary Completion Date

October 2010

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
      

Gender

All

Ages

21 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Arthur J Hartz, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00983502

Organization ID

25988

Secondary IDs

R21AT004537-02

Responsible Party

Sponsor

Study Sponsor

University of Utah

Collaborators

 National Institutes of Health (NIH)

Study Sponsor

Arthur J Hartz, MD, PhD, Principal Investigator, Huntsman Cancer Institute/ University of Utah


Verification Date

December 2011