Chronic Fatigue Syndrome Clinical Trial
Official title:
Behavioral Insomnia Therapy With Chronic Fatigue Syndrome
The purpose of this study is to determine how best to manage the sleep problems of people with Chronic Fatigue Syndrome. This study is being conducted to determine how improvements in sleep affect other Chronic Fatigue symptoms including pain, fatigue, and mood as well as a person's sense of general well-being.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
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