Fatigue Self-Management in Primary Care

Chronic Fatigue Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997451
• Other study ID #: NIH 5R01NR010229 - 03
• Status: Completed
• Phase: N/A
• First received: March 28, 2009
• Last updated: September 28, 2012
• Start date: February 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2012
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• diagnosis of unexplained chronic fatigue

• diagnosis of chronic fatigue syndrome

Exclusion Criteria:

• medically explained fatigue

• any psychosis or dementia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Medically Unexplained Chronic Fatigue

Intervention

Behavioral:
• Cognitive-behavioral self-management
Graded activity, pacing, stress reduction, low effort pleasant activities, cognitive coping skills.
• Symptom monitoring
Daily symptom via web diary

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Severity Scale		3 months, 6 months, 15 months	No
Secondary	Beck Anxiety Inventory		3 months, 6 months, 15 months	No
Secondary	Beck Depression Inventory		3 months, 6 months, 15 months	No
Secondary	SF-36 physical function subscale		3 months, 6 months, 15 months	No
Secondary	Global Impression of Change Rating		3 months, 6 months, 15 months	No