Fatigue Self-Management in Primary Care

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

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • medically explained fatigue
  • any psychosis or dementia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997451

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

No publications provided by Stony Brook University

Additional 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
Study First Received: March 28, 2009
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2014