PatientsVille.com LogoPatientsVille.com

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

Insomnia research study

What is the primary objective of this study?

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 = 200) or (2) standard care (n = 100), consisting of 6 weekly sessions administered individually by a professional.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Insomnia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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.

Behavioral: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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Professionally Administered CBT-I (Standard Care)Patients 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-IPatients having an ISI score > 7 but < 15 (approximately 100 patients), 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 (approximately 100 patients) will receive six weekly sessions of CBT-I administered individually by a professional.

Study Status

Active, not recruiting

Start Date: September 2013

Completed Date: December 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change in Insomnia Severity Index

Secondary Outcome: Change in sleep onset latency (SOL) - from sleep diary

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: CHU de Quebec-Universite Laval

Collaborator: Canadian Institutes of Health Research (CIHR)

More information:https://clinicaltrials.gov/show/NCT01864720

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.

Discuss Insomnia