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Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue

NCT ID: NCT00983502

Last Updated: 2011-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Idiopathic Chronic Fatigue Chronic Fatigue Syndrome Myalgic Encephalomyelitis

Keywords

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Idiopathic Chronic Fatigue Chronic Fatigue Syndrome Myalgic encephalomyelitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Integrative Medicine

Patients of MD practitioners trained in Complementary and Alternative Medicine

No interventions assigned to this group

Naturopath Doctors

Patients of practitioners who are not MD's and are trained in Naturopathic Medicine

No interventions assigned to this group

Chronic Fatigue Specialists

Patients of MD's who specialize in treating Chronic Fatigue and related conditions

No interventions assigned to this group

Control Group

Patients treated by primary care MDs in practice-based research networks

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arthur J Hartz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute/ University of Utah

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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R21AT004537-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25988

Identifier Type: -

Identifier Source: org_study_id