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

Insomnia Clinical Trial

— Stepped Care  

Official title:

A Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients : Efficacy and Cost-Effectiveness.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864720
• Other study ID #: IC103664
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: November 2018

Study information

• Verified date: March 2022
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.
• Web-based cognitive-behavioral therapy for insomnia (CBT-I)
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.

Locations

Country	Name	City	State
Canada	Centre de recherche de L'Hôtel-Dieu de Québec	Québec

Sponsors (2)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)