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Fatigue Self-Management in Primary Care

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.
 
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

Tracking Information
First Submitted Date  ICMJE March 28, 2009
First Posted Date  ICMJE October 19, 2009
Last Update Posted Date October 1, 2012
Study Start Date  ICMJE February 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2009)		 Fatigue Severity Scale [ Time Frame: 3 months, 6 months, 15 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fatigue Self-Management in Primary Care
Official Title  ICMJE Fatigue Self- Management in Primary Care: Efficacy, Credibility, and Economics
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Medically Unexplained Chronic Fatigue
  • Chronic Fatigue Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2012)		 107
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2009)		 108
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • medically explained fatigue
  • any psychosis or dementia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00997451
Other Study ID Numbers  ICMJE NIH 5R01NR010229 - 03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stony Brook University
Study Sponsor  ICMJE Stony Brook University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fred Friedberg, PhD Stony Brook University
PRS Account Stony Brook University
Verification Date September 2012

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