Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia

Completed · Phase 2/Phase 3

Conditions studied: Fibromyalgia, Sleep Initiation and Maintenance Disorders

In brief

Fibromyalgia (FM) is a common and chronic disorder characterized by widespread muscle pain, fatigue, and multiple tender points. The majority of individuals with FM report sleep problems, including delayed sleep onset, extended awakenings, and non-restorative sleep. These sleep disturbances may worsen FM-related pain, fatigue, low mood, and low energy. The purpose of this study is to evaluate the effectiveness of cognitive behavioral insomnia therapy in reducing sleep disturbances and improving other FM-related symptoms.

Key facts

Study ID

NCT00321451

Run by

Duke University

People needed

111

Starts

2006-05-01

Expected to finish

2011-02-01

Last updated by the study team

2016-01-29

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Reside in or around Durham, NC
• History of insomnia complaints for more than 1 month
• Diagnosis of primary FM
• Diagnosis of insomnia

You may not qualify if…

• Terminal illness or acute serious medical illness
• Secondary FM or condition other than FM that seriously compromises sleep
• Current psychiatric illness or currently suicidal
• Substance abuse or dependence
• Other primary sleep disorder (e.g., sleep apnea or restless legs syndrome)

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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