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Fatigue Self-Management in Primary Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00997451
First received: March 28, 2009
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  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
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
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

ClinicalTrials.gov processed this record on May 22, 2013