Fatigue Self-Management in Primary Care

September 28, 2012 updated by: Stony Brook University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • medically explained fatigue
  • any psychosis or dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue Severity Scale
Time Frame: 3 months, 6 months, 15 months
3 months, 6 months, 15 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Anxiety Inventory
Time Frame: 3 months, 6 months, 15 months
3 months, 6 months, 15 months
Beck Depression Inventory
Time Frame: 3 months, 6 months, 15 months
3 months, 6 months, 15 months
SF-36 physical function subscale
Time Frame: 3 months, 6 months, 15 months
3 months, 6 months, 15 months
Global Impression of Change Rating
Time Frame: 3 months, 6 months, 15 months
3 months, 6 months, 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: Fred Friedberg, PhD, Stony Brook University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 28, 2009

First Submitted That Met QC Criteria

October 16, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Estimate)

October 1, 2012

Last Update Submitted That Met QC Criteria

September 28, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIH 5R01NR010229 - 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Fatigue Syndrome

Clinical Trials on Cognitive-behavioral self-management

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe