Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients

Official Title

A Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients : Efficacy and Cost-Effectiveness.

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 = 200) or (2) standard care (n = 100), consisting of 6 weekly sessions administered individually by a professional.

Trial Description

Primary Outcome:

  • Change in Insomnia Severity Index
  • Change in sleep efficiency (SE) index (%)
Secondary Outcome:
  • Change in sleep onset latency (SOL) - from sleep diary
  • Change in wake after sleep onset (WASO) - from sleep diary
  • Change in total wake time (TWT) - from sleep diary
  • Change in total sleep time (TST) - from sleep diary
  • Change in hypnotic use - from sleep diary
  • Change in sleep onset latency (SOL) - from actigraphy
  • Change in wake after sleep onset (WASO) - from actigraphy
  • Change in total wake time (TWT) - from actigraphy
  • Change in total sleep time (TST) - from actigraphy
  • Change in sleep efficiency (SE) index (%) - from actigraphy

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society