Back to resultsFatigue Self-Management in Primary Care
Primary Purpose
Medically Unexplained Chronic Fatigue, Chronic Fatigue Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral self-management
Symptom monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Medically Unexplained Chronic Fatigue focused on measuring Medically unexplained chronic fatigue, Chronic fatigue syndrome, Cognitive-behavior therapy, Self-management, Primary care, Nurses, Economic analysis, Cost effectiveness, One year follow-up
Eligibility Criteria
Inclusion Criteria:
- diagnosis of unexplained chronic fatigue
- diagnosis of chronic fatigue syndrome
Exclusion Criteria:
- medically explained fatigue
- any psychosis or dementia
Sites / Locations
- Stony Brook University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Behavioral Self-Management
Symptom Monitoring
Standard Medical Care
Arm Description
Cognitive-behavioral self-management
Outcomes
Primary Outcome Measures
Fatigue Severity Scale
Secondary Outcome Measures
Beck Anxiety Inventory
Beck Depression Inventory
SF-36 physical function subscale
Global Impression of Change Rating
Full Information
NCT ID
NCT00997451
First Posted
March 28, 2009
Last Updated
September 28, 2012
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT00997451
Brief Title
Fatigue Self-Management in Primary Care
Official Title
Fatigue Self- Management in Primary Care: Efficacy, Credibility, and Economics
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stony Brook University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medically Unexplained Chronic Fatigue, Chronic Fatigue Syndrome
Keywords
Medically unexplained chronic fatigue, Chronic fatigue syndrome, Cognitive-behavior therapy, Self-management, Primary care, Nurses, Economic analysis, Cost effectiveness, One year follow-up
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Self-Management
Arm Type
Experimental
Arm Description
Cognitive-behavioral self-management
Arm Title
Symptom Monitoring
Arm Type
Active Comparator
Arm Title
Standard Medical Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral self-management
Intervention Description
Graded activity, pacing, stress reduction, low effort pleasant activities, cognitive coping skills.
Intervention Type
Behavioral
Intervention Name(s)
Symptom monitoring
Intervention Description
Daily symptom via web diary
Primary Outcome Measure Information:
Title
Fatigue Severity Scale
Time Frame
3 months, 6 months, 15 months
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory
Time Frame
3 months, 6 months, 15 months
Title
Beck Depression Inventory
Time Frame
3 months, 6 months, 15 months
Title
SF-36 physical function subscale
Time Frame
3 months, 6 months, 15 months
Title
Global Impression of Change Rating
Time Frame
3 months, 6 months, 15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of unexplained chronic fatigue
diagnosis of chronic fatigue syndrome
Exclusion Criteria:
medically explained fatigue
any psychosis or dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Friedberg, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25421363
Citation
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.
Results Reference
derived
PubMed Identifier
23922399
Citation
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.
Results Reference
derived
Learn more about this trial
Fatigue Self-Management in Primary Care
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