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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I)
* Behavioral: Web-based cognitive-behavioral therapy for insomnia (CBT-I)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Professionally Administered CBT-I (Standard Care)<br>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. | Behavioral: Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I)<br>* 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.<br>|
| Experimental: Stepped Care CBT-I<br>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. | Behavioral: Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I)<br>* 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.<br>Behavioral: Web-based cognitive-behavioral therapy for insomnia (CBT-I)<br>* 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.<br>* Other names: Self-administered;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index | total score | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | 
| Change in sleep efficiency (SE) index (%) | total sleep time/total time spent in bed X 100 - 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep onset latency (SOL) - from sleep diary | time to sleep after lights out - 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) | 
| Change in wake after sleep onset (WASO) - from sleep diary | summation of nocturnal awakenings - 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) | 
| Change in total wake time (TWT) - from sleep diary | summation of SOL, WASO, and early morning awakening - 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) | 
| Change in total sleep time (TST) - from sleep diary | time in bed minus total wake time - 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) | 
| Change in hypnotic use - from sleep diary | use of sleep-promoting medications - 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) | 
| Change in sleep onset latency (SOL) - from actigraphy | time to sleep after lights out - 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) | 
| Change in wake after sleep onset (WASO) - from actigraphy | summation of nocturnal awakenings - 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) | 
| Change in total wake time (TWT) - from actigraphy | summation of SOL, WASO, and early morning awakening - 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) | 
| Change in total sleep time (TST) - from actigraphy | time in bed minus total wake time - 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) | 
| Change in sleep efficiency (SE) index (%) - from actigraphy | ratio of total sleep time to the actual time spent in bed multiplied by 100 | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stepped care model, insomnia, cancer, cognitive-behavioural therapy, self-help treatment, web-based intervention, non-inferiority design, cost-effectiveness