Behavioral Insomnia Therapy With Chronic Fatigue Syndrome

This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Chronic Fatigue, Insomnia, Cognitive Behavioral Therapy Read More

Inclusion Criteria:

• Chronic Fatigue Syndrome and Insomnia
• meet diagnostic criteria for insomnia
• be diagnosed with CFS by the Study Physician using CDC criteria
• 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.

Study patients can have comorbid depression (as long as it is not bipolar, melancholic or psychotic) or fibromyalgia. They can be taking sleep medications.

Exclusion Criteria:

• Those with untreated medical disorders that could account for the fatigue, or affect sleep. Medical conditions that would exclude a participant include:

  • organ failure resulting from conditions such as emphysema, cirrhosis, cardiac failure, chronic renal failure
  • chronic infections, including AIDS, and hepatitis B or C
  • rheumatic and chronic inflammatory diseases that could account for the fatigue: including systemic lupus erythematosis, Sjogren's syndrome, rheumatoid arthritis, inflammatory bowel disease, chronic pancreatitis
  • major neurologic diseases (e.g., multiple sclerosis, neuromuscular diseases, epilepsy or other diseases requiring ongoing medication that could cause fatigue, stroke, head injury with residual neurologic deficits)
  • diseases requiring systemic treatment (e.g., organ or bone marrow transplantation, systemic chemotherapy, radiation of brain, thorax, abdomen, or pelvis)
  • untreated major endocrine diseases (e.g., hypopituitarism, adrenal insufficiency)
  • being on medications with known fatigue side effects or medications that have not been stable for at least one month
  • inadequately-treated hypothyroidism
  • untreated or unstable diabetes mellitus
  • active infection
  • pregnancy, 1-3 months post-partum or breast feeding
  • within 6 months post-operation for a major surgical procedure
  • within 3 months post-operation of minor surgery
  • major infections, such as sepsis or pneumonia until 3 months post-resolution
  • major conditions whose resolution may be unclear for at least 5 years (e.g., myocardial infarction, heart failure)
  • terminal conditions
  • severe obesity as defined as a body mass index (weight in kilograms/height in meters)2 > 40
  • elective surgery planned during 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)
• 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.