Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Insomnia is very common in cancer patients. When left untreated, insomnia can lead to
      numerous serious consequences (e.g., psychological disorders) for the individual and
      significant costs for society (e.g., increased medical consultations). Cognitive-behavioural
      therapy (CBT), a form of psychotherapy, is now considered the treatment of choice for
      insomnia and its efficacy has been demonstrated in clinical studies conducted in cancer
      patients. Unfortunately, CBT for insomnia (CBT-I) is not widely accessible as only a few
      cancer clinics have mental health professionals formally trained in the administration of
      this treatment. Innovative models of treatment delivery are therefore needed to make sure
      that every cancer patient with insomnia receives the care he/she needs. A stepped care
      approach in which patients only receive the level of treatment that they need, beginning with
      a minimal, less costly, intervention followed by more intensive treatment if required, has
      shown some promises for other psychological disorders (e.g., depression). Although its
      relevance has been emphasized to make CBT-I more accessible, its utility has never been
      investigated. The main goal of this randomized non-inferiority study is to assess the
      efficacy and costeffectiveness of a stepped care CBT-I as compared with standard care. Our
      hypothesis is that a stepped care approach will not be statistically inferior in terms of
      efficacy as compared to usual care, while being much less costly (better cost-effectiveness
      ratio). Three hundred cancer patients (mixed cancer sites) with insomnia symptoms will be
      assigned to: (1) stepped care CBT-I (n = 118) or (2) standard care (n = 59), consisting of 6
      weekly sessions administered individually by a professional.
    


Intervention name(s): Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I); Web-based cognitive-behavioral therapy for insomnia (CBT-I)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The treatment content will be the same whether it is administered by a professional or self-administered. This multimodal approach combines behavioural (i.e., stimulus control therapy, sleep restriction), cognitive (i.e., cognitive restructuring), and educational (i.e., sleep hygiene) strategies that are administered over a 6-week period.; The treatment content will be the same whether it is administered by a professional or self-administered. Each week, the patients will first have to read written information on the website, and then watch a video capsule (duration between 5 and 20 min each). The treatment material will be identical to the video (DVD)-based CBT-I that we previously developed. Patients will complete their daily sleep diary electronically on the website and the content will be interactive. It will include the sending of automated emails to remind participants to complete the treatment tasks and encourage adherence, provision of tailored feedback (e.g., texts, charts) based on the information that they provide in their sleep diary, as well as quizzes with automated correction to reinforce patients' understanding of the content.
Other intervention name(s): Self-administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stepped care model; insomnia; cancer; cognitive-behavioural therapy; self-help treatment; web-based intervention; non-inferiority design; cost-effectiveness