Behavioral Insomnia Therapy With Chronic Fatigue Syndrome topic
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| ClinicalTrials.gov Identifier |
- NCT00540254
| Type of trial |
| Primary outcomes |
- Beliefs about sleep
- Sleep efficiency
- Sleep habits
- Total sleep time
- Total wake time
| Secondary outcomes |
- Actigraphy (measurement of activity)
- Scores on measures of fatigue, mood, anxiety, quality of life, chronic fatigue syndrome symptoms, fibromyalgia symptoms, medication usage
| Start date |
- Sep 2007
| End date |
- Sep 2009
| Last follow-up |
| Phase |
| Expected total enrollment |
- 50
| Eligibile genders |
| Minimum age for eligibility |
- 21
| Maximum age for eligibility |
- 65
| Eligibility inclusion criteria |
- Be diagnosed with CFS by the Study Physician using CDC criteria
- Chronic Fatigue Syndrome and Insomnia
- Meet diagnostic criteria for insomnia
- Must be in current treatment for CFS (we can provide referrals if needed)
- Under medical care for a minimum of 6 weeks with a stable medication regimen for > 1 month
| Eligibility exclusion criteria |
- Those with untreated medical disorders that could account for the fatigue, or affect sleep
- We will exclude those meeting criteria for Narcolepsy, Restless Legs Syndrome, a Circadian Rhythm Disorder, or sleep apnea and/or hypopnea
- We will exclude those who meet DSM-IV criteria currently or in the past 5 years for psychotic or melancholic Major Depression, bipolar disorders, schizophrenia, or eating disorders, alcohol or substance abuse or dependence (e.g., dependence on benzodiazepines or any other substance)
- We will exclude those with a medication change within the last month to ensure participants are on a stable dose and regimen of medication. *Once potential patients have had a stable medication regimen for > 1 month, participants can enter the trial
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| Contact |
| References |
| Diseases |
| Treatment being tested |
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