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Fatigue Self-Management in Primary Care

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ClinicalTrials.gov Identifier: NCT00997451
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):
Stony Brook University

Study Description
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Brief Summary:
This study will evaluate, in a primary care setting, the effectiveness of a brief self-management behavioral treatment in patients with medically unexplained chronic fatigue. The hypothesis will be tested that fatigue self-management will yield improvements in fatigue,functioning, and distress in comparison to the two control conditions: standard medical care alone or standard medical care plus an attention control symptom monitoring condition.

Condition or disease Intervention/treatment Phase
Medically Unexplained Chronic Fatigue Chronic Fatigue Syndrome Behavioral: Cognitive-behavioral self-management Behavioral: Symptom monitoring Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Fatigue Self- Management in Primary Care: Efficacy, Credibility, and Economics
Study Start Date : February 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Arm Intervention/treatment
Experimental: Behavioral Self-Management
Cognitive-behavioral self-management
 Behavioral: Cognitive-behavioral self-management
Graded activity, pacing, stress reduction, low effort pleasant activities, cognitive coping skills.
Active Comparator: Symptom Monitoring Behavioral: Symptom monitoring
Daily symptom via web diary
No Intervention: Standard Medical Care


Outcome Measures
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Primary Outcome Measures :
  1. Fatigue Severity Scale [ Time Frame: 3 months, 6 months, 15 months ]

Secondary Outcome Measures :
  1. Beck Anxiety Inventory [ Time Frame: 3 months, 6 months, 15 months ]
  2. Beck Depression Inventory [ Time Frame: 3 months, 6 months, 15 months ]
  3. SF-36 physical function subscale [ Time Frame: 3 months, 6 months, 15 months ]
  4. Global Impression of Change Rating [ Time Frame: 3 months, 6 months, 15 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of unexplained chronic fatigue
  • diagnosis of chronic fatigue syndrome

Exclusion Criteria:

  • medically explained fatigue
  • any psychosis or dementia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997451


Locations
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United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Fred Friedberg, PhD Stony Brook University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT00997451    
Other Study ID Numbers: NIH 5R01NR010229 - 03
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: October 1, 2012
Last Verified: September 2012
Keywords provided by Stony Brook University:
Medically unexplained chronic fatigue
Chronic fatigue syndrome
Cognitive-behavior therapy
Self-management
Primary care
 Nurses
Economic analysis
Cost effectiveness
One year follow-up
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Fatigue
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
 Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases