Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients
- Conditions
- Insomnia
- Interventions
- Behavioral: Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I)Behavioral: Web-based cognitive-behavioral therapy for insomnia (CBT-I)
- Registration Number
- NCT01864720
- Lead Sponsor
- CHU de Quebec-Universite Laval
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 177
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stepped Care CBT-I Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I) Patients having an ISI score \> 7 but \< 15 (n = 65), will all receive first a web-based CBT-I for six weeks. 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). Patients with an ISI score \> 14 (n = 53) will receive six weekly sessions of CBT-I administered individually by a professional. Professionally Administered CBT-I (Standard Care) Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I) Patients (n = 59) assigned to this group will receive 6 weekly sessions of cognitive-behavioral therapy for insomnia (CBT-I) of approximately 50 minutes, offered individually by a licensed psychologist with significant experience (at least 2 years) in the administration of CBT-I with cancer patients. Stepped Care CBT-I Web-based cognitive-behavioral therapy for insomnia (CBT-I) Patients having an ISI score \> 7 but \< 15 (n = 65), will all receive first a web-based CBT-I for six weeks. 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). Patients with an ISI score \> 14 (n = 53) will receive six weekly sessions of CBT-I administered individually by a professional.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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 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 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
Trial Locations
- Locations (1)
Centre de recherche de L'Hôtel-Dieu de Québec
🇨🇦Québec, Canada