Behavioral Insomnia Therapy With Chronic Fatigue Syndrome
Medical trial
ClinicalTrials.gov Identifier:
- NCT00540254
Type of trial:
Design:
View entire collection »Primary outcomes:
- Sleep efficiency
- Total wake time
- Beliefs about sleep
- Sleep habits
- Total sleep 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
Expected total enrollment:
- 50
Minimum age for eligibility:
- 21
Maximum age for eligibility:
- 65
Eligibility inclusion criteria:
- Must be in current treatment for CFS (we can provide referrals if needed)
- Meet diagnostic criteria for insomnia
- Under medical care for a minimum of 6 weeks with a stable medication regimen for > 1 month
- Be diagnosed with CFS by the Study Physician using CDC criteria
- Chronic Fatigue Syndrome and Insomnia
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 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
- 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)
