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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00997451
Other study ID # NIH 5R01NR010229 - 03
Secondary ID
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


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
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