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Fatigue Self-Management in Primary Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00997451
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
  Purpose
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.

Condition Intervention
Medically Unexplained Chronic Fatigue Chronic Fatigue Syndrome Behavioral: Cognitive-behavioral self-management Behavioral: Symptom monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Fatigue Self- Management in Primary Care: Efficacy, Credibility, and Economics

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Fatigue Severity Scale [ Time Frame: 3 months, 6 months, 15 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 107
Study Start Date: February 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Self-Management
Cognitive-behavioral self-management
Behavioral: Cognitive-behavioral self-management
Graded activity, pacing, stress reduction, low effort pleasant activities, cognitive coping skills.
Active Comparator: Symptom Monitoring Behavioral: Symptom monitoring
Daily symptom via web diary
No Intervention: Standard Medical Care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • medically explained fatigue
  • any psychosis or dementia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997451


Locations
United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Fred Friedberg, PhD Stony Brook University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT00997451     History of Changes
Other Study ID Numbers: NIH 5R01NR010229 - 03
First Submitted: March 28, 2009
First Posted: October 19, 2009
Last Update Posted: October 1, 2012
Last Verified: September 2012

Keywords provided by Stony Brook University:
Medically unexplained chronic fatigue
Chronic fatigue syndrome
Cognitive-behavior therapy
Self-management
Primary care
Nurses
Economic analysis
Cost effectiveness
One year follow-up

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases