Behavioral Insomnia Therapy With Chronic Fatigue Syndrome
Condition: Chronic Fatigue Syndrome; Behavioral Therapy Targeted to Sleep Problems
MeSH terms: Fatigue Syndrome, Chronic; Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Cognitive Behavioral Therapy; Usual Care for Chronic Fatigue Syndrome (Active Control Group)
Intervention type(s): Behavioral; Other
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Chronic Fatigue; Insomnia; Cognitive Behavioral Therapy