Fatigue Self-Management in Primary Care

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	Complete list of historical versions of study NCT00997451 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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 *	Meng H, Friedberg F, Castora-Binkley M. Cost-effectiveness of chronic fatigue self-management versus usual care: a pilot randomized controlled trial. BMC Fam Pract. 2014 Nov 25;15:184. doi: 10.1186/s12875-014-0184-7.; 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 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	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	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	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	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