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Fatigue Self-Management in Primary Care

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 19, 2009
Last Update Posted: October 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stony Brook University
March 28, 2009
October 19, 2009
October 1, 2012
February 2009
December 2011   (Final data collection date for primary outcome measure)
Fatigue Severity Scale [ Time Frame: 3 months, 6 months, 15 months ]
Same as current
Complete list of historical versions of study NCT00997451 on ClinicalTrials.gov Archive Site
  • Beck Anxiety Inventory [ Time Frame: 3 months, 6 months, 15 months ]
  • Beck Depression Inventory [ Time Frame: 3 months, 6 months, 15 months ]
  • SF-36 physical function subscale [ Time Frame: 3 months, 6 months, 15 months ]
  • Global Impression of Change Rating [ Time Frame: 3 months, 6 months, 15 months ]
Same as current
Not Provided
Not Provided
Fatigue Self-Management in Primary Care
Fatigue Self- Management in Primary Care: Efficacy, Credibility, and Economics
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.
Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Medically Unexplained Chronic Fatigue
  • Chronic Fatigue Syndrome
  • Behavioral: Cognitive-behavioral self-management
    Graded activity, pacing, stress reduction, low effort pleasant activities, cognitive coping skills.
  • Behavioral: Symptom monitoring
    Daily symptom via web diary
  • Experimental: Behavioral Self-Management
    Cognitive-behavioral self-management
    Intervention: Behavioral: Cognitive-behavioral self-management
  • Active Comparator: Symptom Monitoring
    Intervention: Behavioral: Symptom monitoring
  • No Intervention: Standard Medical Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • medically explained fatigue
  • any psychosis or dementia
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NIH 5R01NR010229 - 03
Not Provided
Not Provided
Stony Brook University
Stony Brook University
Not Provided
Principal Investigator: Fred Friedberg, PhD Stony Brook University
Stony Brook University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP