Fatigue Self-Management in Primary Care

Not Applicable

Completed

• Conditions: Medically Unexplained Chronic Fatigue; Chronic Fatigue Syndrome
• Interventions: Behavioral: Cognitive-behavioral self-management; Behavioral: Symptom monitoring

• Registration Number: NCT00997451
• Lead Sponsor: Stony Brook University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-28
• Study First Submitted QC: 2009-10-16
• Study First Posted: 2009-10-19
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-28
• Last Update Posted: 2012-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

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

Exclusion Criteria

• medically explained fatigue
• any psychosis or dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Self-Management	Cognitive-behavioral self-management	Cognitive-behavioral self-management
Symptom Monitoring	Symptom monitoring	-

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale	3 months, 6 months, 15 months

Secondary Outcome Measures

Name	Time	Method
Beck Anxiety Inventory	3 months, 6 months, 15 months
Beck Depression Inventory	3 months, 6 months, 15 months
SF-36 physical function subscale	3 months, 6 months, 15 months
Global Impression of Change Rating	3 months, 6 months, 15 months

Trial Locations

Locations (1)

Stony Brook University; 🇺🇸 Stony Brook, New York, United States