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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Québec, CHU de Québec
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01864720
First received: May 21, 2013
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Insomnia
Behavioral: Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I)
Behavioral: Web-based cognitive-behavioral therapy for insomnia (CBT-I)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients : Efficacy and Cost-Effectiveness.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    total sleep time/total time spent in bed X 100 - from sleep diary


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    time to sleep after lights out - from sleep diary

  • 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) ] [ Designated as safety issue: No ]
    summation of nocturnal awakenings - from sleep diary

  • 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) ] [ Designated as safety issue: No ]
    summation of SOL, WASO, and early morning awakening - from sleep diary

  • 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) ] [ Designated as safety issue: No ]
    time in bed minus total wake time - from sleep diary

  • 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) ] [ Designated as safety issue: No ]
    use of sleep-promoting medications - from sleep diary

  • 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) ] [ Designated as safety issue: No ]
    time to sleep after lights out - from actigraphy

  • 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) ] [ Designated as safety issue: No ]
    summation of nocturnal awakenings - from actigraphy

  • 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) ] [ Designated as safety issue: No ]
    summation of SOL, WASO, and early morning awakening - from actigraphy

  • 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) ] [ Designated as safety issue: No ]
    time in bed minus total wake time - from actigraphy

  • 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) ] [ Designated as safety issue: No ]
    ratio of total sleep time to the actual time spent in bed multiplied by 100


Estimated Enrollment: 300
Study Start Date: September 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Experimental: Stepped Care CBT-I
Patients 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.
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.
Other Name: Self-administered

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864720

Locations
Canada, Quebec
Centre de recherche de L'Hôtel-Dieu de Québec Recruiting
Québec, Quebec, Canada, G1R 2J6
Contact: Marie-Hélène Savard, Ph.D.    1-418-525-4444 ext 20618    marie-helene.savard@crchuq.ulaval.ca   
Principal Investigator: Josée Savard, Ph.D.         
Sub-Investigator: Stéphane Bouchard, Ph.D.         
Sub-Investigator: Charles M Morin, Ph.D.         
Sub-Investigator: Guy Lacroix, Ph.D.         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT01864720     History of Changes
Other Study ID Numbers: IC103664
Study First Received: May 21, 2013
Last Updated: March 14, 2014
Health Authority: Canada: Ministère santé et services sociaux du Québec

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
stepped care model
insomnia
cancer
cognitive-behavioural therapy
self-help treatment
Internet
non-inferiority design
cost-effectiveness

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014