NCT00540254

Behavioral Insomnia Therapy With Chronic Fatigue Syndrome

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Fatigue Syndrome
• Behavioral Therapy Targeted to Sleep Problems

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy	Cognitive Behavioral Therapy (CBT) + Insomnia plus Usual Care for Chronic Fatigue Syndrome -continues standard care for Chronic Fatigue Syndrome plus 4 sessions of CBT targeted for insomnia/sleep problems
OTHER	Usual Care for Chronic Fatigue Syndrome (Active Control Group)	Usual Care for Chronic Fatigue Syndrome (Active Control Group) - continues standard care for Chronic Fatigue Syndrome and comes to the sleep lab for bi-weekly sessions to discuss sleep problems and to review weekly sleep logs

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2007-10-05
• Last updated: 2013-03-01

Locations

1 site across 1 country: United States