InsomniaStepped CareNCT01864720

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

A study testing Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I) and Web-based cognitive-behavioral therapy for insomnia (CBT-I) in people with Insomnia, run by CHU de Quebec-Universite Laval at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Insomnia
What is being tested?: Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I) and Web-based cognitive-behavioral therapy for insomnia (CBT-I)
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 177 participants
Where: 1 siteCanada
Study dates: Sep 2013to Nov 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre de recherche de L'Hôtel-Dieu de Québec
Québec, G1R 2J6

Other trials in Canada

About this study

Official title: 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.

Conditions: Insomnia
Being tested: Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I), Web-based cognitive-behavioral therapy for insomnia (CBT-I)
Keywords: stepped care model, insomnia, cancer, cognitive-behavioural therapy, self-help treatment, web-based intervention, non-inferiority design, cost-effectiveness
Medical subject headings: Sleep Initiation and Maintenance Disorders, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I)Behavioural
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.
Web-based cognitive-behavioral therapy for insomnia (CBT-I)Behavioural
Also called Self-administered
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.

Study groups in NCT01864720
Study group	Role	What they receive
Professionally Administered CBT-I (Standard Care)	Active comparator	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. Receives: Behavioral: Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I)
Stepped Care CBT-I	Experimental	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. Receives: Behavioral: Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I); Behavioral: Web-based cognitive-behavioral therapy for insomnia (CBT-I)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Insomnia Severity Index
total score
Measured: 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
Measured: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)

Secondary outcomes (10)

Change in sleep onset latency (SOL) - from sleep diary
time to sleep after lights out - from sleep diary
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4), 12-month FU (T5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Nov 2018

First posted30 May 2013 (estimated)
Study startSep 2013
Primary completionNov 2018
Study completionNov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 177 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01864720
Sponsor's protocol ID: IC103664
Acronym: Stepped Care
Status last verified: Mar 2022
First submitted: 21 May 2013
Last updated: 28 Mar 2022
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 20041590
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.
PubMed 18591549
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.
PubMed 16135475
Garneau J, Savard J, Dang-Vu TT, Gouin JP. Predicting response to stepped-care cognitive behavioral therapy for insomnia using pre-treatment heart rate variability in cancer patients. Sleep Med. 2024 Sep;121:160-170. doi: 10.1016/j.sleep.2024.06.021. Epub 2024 Jun 26.
PubMed 38991424
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.
PubMed 34228123

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients : Efficacy and Cost-Effectiveness.
ClinicalTrials.gov ID: NCT01864720
Acronym / sponsor ID: Stepped Care / IC103664
Conditions: Insomnia
Keywords: stepped care model, insomnia, cancer, cognitive-behavioural therapy, self-help treatment, web-based intervention, non-inferiority design, cost-effectiveness
Study type: Interventional
Recruitment status: Completed
Enrolment: 177 participants (actual)
Lead sponsor: CHU de Quebec-Universite LavalUniversity, hospital or other
Collaborators: Canadian Institutes of Health Research (CIHR)
Study start: Sep 2013
Primary completion: Nov 2018 (actual)
Study completion: Nov 2018 (actual)
First posted: 30 May 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Professionally Administered CBT-I (Standard Care)	Active comparator	Behavioral: 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	Experimental	Behavioral: Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I), Behavioral: 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Professionally-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.	Behavioural	Professionally Administered CBT-I (Standard Care), Stepped Care CBT-I
Web-based cognitive-behavioral therapy for insomnia (CBT-I)Also: Self-administeredThe 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.	Behavioural	Stepped Care CBT-I

Primary outcome

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)
total score
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)
total sleep time/total time spent in bed X 100 - from sleep diary

10 secondary outcomes

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
Background: PubMed 20041590Espie 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.
Background: PubMed 18591549Espie 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.
Background: PubMed 16135475Savard 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.
Derived from this study: PubMed 38991424Garneau J, Savard J, Dang-Vu TT, Gouin JP. Predicting response to stepped-care cognitive behavioral therapy for insomnia using pre-treatment heart rate variability in cancer patients. Sleep Med. 2024 Sep;121:160-170. doi: 10.1016/j.sleep.2024.06.021. Epub 2024 Jun 26.
Derived from this study: PubMed 34228123Savard 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01864720, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.