Behavioral Insomnia Therapy With Chronic Fatigue Syndrome

Chronic Fatigue Syndrome (CFS) is a prevalent, debilitating, and poorly understood condition
that contributes to impaired functioning and increased health care utilization. The vast
majority of CFS patients complain of unrelenting sleep disturbances (e.g., sleep onset
insomnia and/or sleep maintenance insomnia) that could exacerbate symptoms such as fatigue,
mood disturbance, and reduced quality of life. Research with normal sleepers and insomnia
sufferers has demonstrated that sleep disruption adversely affects those systems
hypothesized to be important in CFS (e.g., neuroendocrine and autonomic systems). Insomnia
appears to be a perpetuating factor in CFS, as insomnia appears to develop as a comorbid
condition that interacts with and worsens CFS. Perhaps because the insomnia of CFS patients
traditionally has been viewed as a secondary symptom rather than as a comorbid disorder, the
sleep-specific treatment needs of CFS patients have been largely ignored. In fact, there
have been few studies conducted to test sleep-focused therapies with CFS patients. Both our
clinical observations and our preliminary studies suggest that those with CFS display sleep
targets (i.e., increased time-in-bed, decreased daytime activity) that are common to those
with Primary and other comorbid insomnias. These phenomena are known to perpetuate sleep
problems, and likely account for the chronic insomnia among CFS patients. Given the high
prevalence and cost associated with CFS, as well as its complex clinical picture,
interventions that directly address perpetuating mechanisms would likely improve the sleep
and general prognosis for these patients.

The proposed randomized clinical trial will allow us to test the effects of CBT for Insomnia
on sleep and waking functions among CFS patients. Positive results could lead to enhanced
CFS outcomes by treating the comorbid insomnia effectively.

The consent form for this study will provide participants with information about who will
provide their care during the study, the purpose of the study, the number of participants
expected in the study, what is required of participants in the study, information about
random assignment to study groups, how long participation in the study will last, the risks
associated with the study, possible benefits of participation, alternatives for treatment
other than participation in this study, information about confidentiality, costs to the
participants associated with the study, compensation for participation, and who to contact
if there questions about the study or injuries related to the study, the right to stop
participating and withdraw from the study.

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.