- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01864720
Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients (Stepped Care)
March 11, 2022 updated by: Josée Savard, CHU de Quebec-Universite Laval
A Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients : Efficacy and Cost-Effectiveness.
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
177
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Québec, Canada, G1R 2J6
- Centre de recherche de L'Hôtel-Dieu de Québec
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Professionally Administered CBT-I (Standard Care)
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.
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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.
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Experimental: Stepped Care 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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Insomnia Severity Index
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)
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total score
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Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)
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Change in sleep efficiency (SE) index (%)
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)
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total sleep time/total time spent in bed X 100 - from sleep diary
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Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in sleep onset latency (SOL) - from sleep diary
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)
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time to sleep after lights out - from sleep diary
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Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)
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Change in wake after sleep onset (WASO) - from sleep diary
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)
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summation of nocturnal awakenings - from sleep diary
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Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)
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Change in total wake time (TWT) - from sleep diary
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)
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summation of SOL, WASO, and early morning awakening - from sleep diary
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Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)
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Change in total sleep time (TST) - from sleep diary
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)
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time in bed minus total wake time - from sleep diary
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Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)
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Change in hypnotic use - from sleep diary
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)
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use of sleep-promoting medications - from sleep diary
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Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)
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Change in sleep onset latency (SOL) - from actigraphy
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)
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time to sleep after lights out - from actigraphy
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Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)
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Change in wake after sleep onset (WASO) - from actigraphy
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)
|
summation of nocturnal awakenings - from actigraphy
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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
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)
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summation of SOL, WASO, and early morning awakening - from actigraphy
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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 Frame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)
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time in bed minus total wake time - from actigraphy
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Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)
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Change in sleep efficiency (SE) index (%) - from actigraphy
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)
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ratio of total sleep time to the actual time spent in bed multiplied by 100
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Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Savard J, Simard S, Ivers H, Morin CM. Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part I: Sleep and psychological effects. J Clin Oncol. 2005 Sep 1;23(25):6083-96. doi: 10.1200/JCO.2005.09.548.
- Espie CA, Fleming L, Cassidy J, Samuel L, Taylor LM, White CA, Douglas NJ, Engleman HM, Kelly HL, Paul J. Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer. J Clin Oncol. 2008 Oct 1;26(28):4651-8. doi: 10.1200/JCO.2007.13.9006. Epub 2008 Jun 30. Erratum In: J Clin Oncol. 2010 Jul 1;28(19):3205.
- Espie CA. "Stepped care": a health technology solution for delivering cognitive behavioral therapy as a first line insomnia treatment. Sleep. 2009 Dec;32(12):1549-58. doi: 10.1093/sleep/32.12.1549.
- Savard J, Ivers H, Savard MH, Morin CM, Caplette-Gingras A, Bouchard S, Lacroix G. Efficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: a noninferiority randomized controlled trial. Sleep. 2021 Nov 12;44(11):zsab166. doi: 10.1093/sleep/zsab166.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
May 21, 2013
First Submitted That Met QC Criteria
May 29, 2013
First Posted (Estimate)
May 30, 2013
Study Record Updates
Last Update Posted (Actual)
March 28, 2022
Last Update Submitted That Met QC Criteria
March 11, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IC103664
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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