Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis; Idiopathic Chronic Fatigue

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
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Integrative Medicine; Patients of MD practitioners trained in Complementary and Alternative Medicine
Naturopath Doctors; Patients of practitioners who are not MD's and are trained in Naturopathic Medicine
Chronic Fatigue Specialists; Patients of MD's who specialize in treating Chronic Fatigue and related conditions
Control Group; Patients treated by primary care MDs in practice-based research networks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Differences among four groups of clinicians with respect to patient treatment outcome	Six months

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Arthur J Hartz, MD, PhD, Huntsman Cancer Institute/ University of Utah

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: September 22, 2009
• First Submitted That Met QC Criteria: September 23, 2009
• First Posted (Estimate): September 24, 2009

Study Record Updates

• Last Update Posted (Estimate): December 15, 2011
• Last Update Submitted That Met QC Criteria: December 13, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Chronic Fatigue Syndrome; Myalgic encephalomyelitis; Idiopathic Chronic Fatigue
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Central Nervous System Infections; Fatigue; Myalgia; Fatigue Syndrome, Chronic; Encephalomyelitis
• Other Study ID Numbers: 25988; R21AT004537-02 (U.S. NIH Grant/Contract)