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临床试验/NCT01864720
NCT01864720已完成不适用

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

CHU de Quebec-Universite Laval2 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
177
试验地点
2
主要终点
Change in Insomnia Severity Index

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in Insomnia Severity Index

时间窗: 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 (%)

时间窗: 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

次要结局

  • Change in sleep onset latency (SOL) - 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))
  • Change in wake after sleep onset (WASO) - 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))
  • Change in total wake time (TWT) - 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))
  • Change in total sleep time (TST) - 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))
  • Change in hypnotic use - 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))
  • Change in sleep onset latency (SOL) - 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))
  • Change in wake after sleep onset (WASO) - 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))
  • Change in total wake time (TWT) - 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))
  • Change in total sleep time (TST) - 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))
  • Change in sleep efficiency (SE) index (%) - 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))

研究者

发起方
CHU de Quebec-Universite Laval
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josée Savard

Researcher

CHU de Quebec-Universite Laval

研究点 (2)

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