Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Fatigue Self-Management in Primary Care

This study has been completed.
Information provided by (Responsible Party):
Stony Brook University Identifier:
First received: March 28, 2009
Last updated: September 28, 2012
Last verified: September 2012

March 28, 2009
September 28, 2012
February 2009
December 2011   (final data collection date for primary outcome measure)
Fatigue Severity Scale [ Time Frame: 3 months, 6 months, 15 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00997451 on Archive Site
  • Beck Anxiety Inventory [ Time Frame: 3 months, 6 months, 15 months ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: 3 months, 6 months, 15 months ] [ Designated as safety issue: No ]
  • SF-36 physical function subscale [ Time Frame: 3 months, 6 months, 15 months ] [ Designated as safety issue: No ]
  • Global Impression of Change Rating [ Time Frame: 3 months, 6 months, 15 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Friedberg F, Napoli A, Coronel J, Adamowicz J, Seva V, Caikauskaite I, Ngan MC, Chang J, Meng H. Chronic fatigue self-management in primary care: a randomized trial. Psychosom Med. 2013 Sep;75(7):650-7. doi: 10.1097/PSY.0b013e31829dbed4. Epub 2013 Aug 6.

*   Includes publications given by the data provider as well as publications identified by 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
18 Years to 70 Years
Contact information is only displayed when the study is recruiting subjects
United States
NIH 5R01NR010229 - 03
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