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OpenTrials
Completed

NCT Number: NCT00997451

Fatigue Self-Management in Primary Care

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.

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Key information

Conditions

Medically Unexplained Chronic Fatigue Chronic Disease Chronic Fatigue Syndrome Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University

Stony Brook, New York, 11794, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • medically explained fatigue
  • any psychosis or dementia

Treatment and study plan

Cognitive-behavioral self-management

Behavioral

Graded activity, pacing, stress reduction, low effort pleasant activities, cognitive coping skills.

Symptom Monitoring

Behavioral

Daily symptom via web diary

Primary outcomes

  1. Fatigue Severity Scale

    Time frame: 3 months, 6 months, 15 months

Secondary outcomes

  1. Beck Anxiety Inventory

    Time frame: 3 months, 6 months, 15 months

  2. Beck Depression Inventory

    Time frame: 3 months, 6 months, 15 months

  3. SF-36 physical function subscale

    Time frame: 3 months, 6 months, 15 months

  4. Global Impression of Change Rating

    Time frame: 3 months, 6 months, 15 months

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

Fatigue Self- Management in Primary Care: Efficacy, Credibility, and Economics

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 19, 2009
Registry last updated
Oct 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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