| City: |
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Durham |
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State:
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NC |
| Zip Code: |
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27710 |
| Conditions: |
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Fibromyalgia - Sleep Initiation and Maintenance Disorders |
| Purpose: |
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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.
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| Study summary: |
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FM is a debilitating condition that can lead to impaired occupational and social
functioning, disability, and increased health care utilization. FM symptoms vary among
individuals, but they typically include chronic widespread pain, persistent daytime fatigue,
sleep disturbances, low mood, and loss of stamina. The cause of FM remains unknown, and
current treatment involves symptom-focused interventions such as antidepressants, behavioral
stress management, coping skills training, and exercise programs. However, there are no
interventions specifically designed to reduce sleep disturbances in people with FM.
Past research has shown that individuals with FM experience the same behavioral and
psychological factors that individuals suffering from insomnia experience. Cognitive
behavioral insomnia therapy, a form of psychotherapy that aims to eliminate factors that
disrupt sleep, may prove useful for people with FM. The purpose of this study is to evaluate
the effectiveness of cognitive behavioral insomnia therapy in reducing sleep disturbances
and improving FM-related pain, fatigue, mood, and quality of life among individuals with FM.
The study will also examine the use of sleep electroencephalogram (EEG) as a means to
measure improvements in FM symptoms.
This study will last about 9 months and will include approximately 16 study visits. An
initial 2-week screening period will include a physical examination, blood collection, a
mental status exam, a tender-point exam, a sleep history questionnaire, and structured sleep
and psychiatric interviews. Participants will complete a 1-week sleep log and one overnight
polysomnogram test, in which several body functions (e.g., brain activity, eye movement,
heart rate, etc.) are recorded. If an FM diagnosis is confirmed, an additional 2-week
assessment period will take place, followed by an 8-week treatment period. During treatment,
participants will be randomly assigned to one of the following three treatment groups: 1)
usual FM care (medical advice and medication prescription), 2) usual FM care plus
psychological treatment to decrease insomnia, and 3) usual FM care plus placebo
psychological treatment to decrease insomnia. Groups 2 and 3 will attend four bi-weekly
individual therapy sessions with a sleep psychologist. Participants will meet with a
rheumatologist at least once. Throughout treatment, nightly sleep logs and medication
questionnaires will be completed, and participants will wear a wrist-watch sized device that
will record their day- and night-time activity. A therapy evaluation questionnaire will be
completed during the first and last weeks of treatment and an outcome questionnaire packet
will be completed after 4 weeks of treatment. All participants will be evaluated following
the end of treatment and again 6 months later. |
| Criteria: |
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Inclusion Criteria:
- Reside in or around Durham, NC
- History of insomnia complaints for more than 1 month
- Diagnosis of primary FM
- Diagnosis of insomnia
Exclusion Criteria:
- 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) |
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| Study is available at: |
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Duke University Medical Center
Durham, NC 27710
United States
Primary Contact:
Meg Lineberger, PhD
Email: meg.lineberger@duke.edu
Phone: 919-668-3267 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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