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


N/A
18 Years
75 Years
Not Enrolling
Both
Insomnia

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Trial Information

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


Inclusion Criteria:



- have received a diagnosis of non-metastatic cancer (any type) in the past -18 months

- to have an ISI score > 8 or be using regularly (> 1 night per week) a psychotropic
medication as a sleep aid (e.g., hypnotic)

- to be aged between 18 and 75 years old

- to be readily able to read and understand French

Exclusion Criteria:

- having a life expectancy < 1 year

- having a severe psychiatric disorder (e.g., psychotic, substance use, severe
depressive disorder)

- having severe cognitive impairments (e.g., diagnosis of Parkinson's disease,
dementia, or Mini-Mental State Examination score < 24)

- having received a formal diagnosis for another sleep disorder (e.g., obstructive
sleep apnea, periodic limb movement disorder)

- shift work in the past 3 months or in the next 12 months

- to have received a psychological treatment specifically for a sleep disorder

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in Insomnia Severity Index

Outcome Description:

total score

Outcome Time Frame:

Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)

Safety Issue:

No

Authority:

Canada: Canadian Institutes of Health Research

Study ID:

IC103664

NCT ID:

NCT01864720

Start Date:

September 2013

Completion Date:

December 2017

Related Keywords:

  • Insomnia
  • stepped care model
  • insomnia
  • cancer
  • cognitive-behavioural therapy
  • self-help treatment
  • Internet
  • non-inferiority design
  • cost-effectiveness
  • Sleep Initiation and Maintenance Disorders

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