Insomnia
Conditions
Keywords
stepped care model, insomnia, cancer, cognitive-behavioural therapy, self-help treatment, web-based intervention, non-inferiority design, cost-effectiveness
Brief 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.
Interventions
BEHAVIORALProfessionally-administered cognitive-behavioral therapy for insomnia (CBT-I)
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.
Sponsors
Canadian Institutes of Health Research (CIHR)
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* have received a diagnosis of non-metastatic cancer (any type) in the past -18 months * to have an ISI score \> 7 * 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 CBT for insomnia in the past
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity Index | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | total score |
| Change in sleep efficiency (SE) index (%) | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | total sleep time/total time spent in bed X 100 - from sleep diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total wake time (TWT) - from sleep diary | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | summation of SOL, WASO, and early morning awakening - from sleep diary |
| Change in total sleep time (TST) - from sleep diary | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | time in bed minus total wake time - from sleep diary |
| Change in hypnotic use - from sleep diary | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | use of sleep-promoting medications - from sleep diary |
| Change in sleep onset latency (SOL) - from actigraphy | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | time to sleep after lights out - from actigraphy |
| Change in sleep onset latency (SOL) - from sleep diary | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | time to sleep after lights out - from sleep diary |
| Change in total wake time (TWT) - from actigraphy | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | summation of SOL, WASO, and early morning awakening - from actigraphy |
| Change in total sleep time (TST) - from actigraphy | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | time in bed minus total wake time - from actigraphy |
| Change in sleep efficiency (SE) index (%) - from actigraphy | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | ratio of total sleep time to the actual time spent in bed multiplied by 100 |
| Change in wake after sleep onset (WASO) - from actigraphy | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | summation of nocturnal awakenings - from actigraphy |
| Change in wake after sleep onset (WASO) - from sleep diary | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | summation of nocturnal awakenings - from sleep diary |
Countries
Canada
Outcome results
None listed