Evidence map›Paper›PMID 34228123›Full record

Trial reportSleep2021

Efficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: a noninferiority randomized controlled trial.

Josée Savard, Hans Ivers, Marie-Hélène Savard, Charles M Morin, Aude Caplette-Gingras, Stéphane Bouchard, Guy Lacroix

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Sleep, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01864720 (A Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients), which is not on this map. Cited by 35 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 7 pooled it
7.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01864720 nacompletednot on this map

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

TypeinterventionalSponsorCHU de Quebec-Universite LavalRan2013 to 2018Enrolled177ConditionsInsomniaArmsProfessionally-administered cognitive-behavioral therapy for insomnia (CBT-I), Web-based cognitive-behavioral therapy for insomnia (CBT-I)
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 7 syntheses or guidelines pooled it, 63 citations in OpenAlex.

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  16. "When symptoms interact and change": longitudinal network analysis of dynamic symptom changes in oral cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Josée SavardSchool of Psychology, Université Laval, Québec, Canada.
Hans IversSchool of Psychology, Université Laval, Québec, Canada.
Marie-Hélène SavardCHU de Québec-Université Laval Research Center, Québec, Canada.
Charles M MorinSchool of Psychology, Université Laval, Québec, Canada.
Aude Caplette-GingrasUniversité Laval Cancer Research Center, Québec, Canada.
Stéphane BouchardDépartement de psychoéducation et de psychologie, Université du Québec en Outaouais et Centre de santé et services sociaux de l'Outaouais, Québec, Canada.
Guy LacroixDépartement d'économique, Université Laval, Québec, Canada.
Université Laval · CAUniversité du Québec en Outaouais · CA

Funding

CIHR #125968
6 · The paper itself

Abstract

STUDY

objectivesCognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for cancer-related insomnia, but its accessibility is very limited in routine care. A stepped care approach has been recommended as a cost-effective way to make CBT-I more widely accessible. However, no controlled study has yet been published about the efficacy of this approach. The goal of this noninferiority randomized controlled trial (RCT) was to compare the short and long-term efficacy of a stepped care CBT-I (StepCBT-I) to a standard face-to-face CBT-I (StanCBT-I).

methodsA total of 177 cancer patients were randomized to: (1) StanCBT-I (6 face-to-face CBT-I sessions; n = 59) or (2) StepCBT-I (n = 118). In the StepCBT-I group, patients with less severe insomnia first received a web-based CBT-I (n = 65), while those with more severe insomnia received 6 face-to-face CBT-I sessions (n = 53). In both cases, patients could receive up to three booster sessions of CBT-I if they still had insomnia symptoms following this first step.

resultsResults indicated that the Step-CBT-I group showed an Insomnia Severity Index score reduction and a sleep efficiency (on a sleep diary) increase that was not significantly inferior to that of StanCBT-I at all post-treatment time points. Analyses of secondary outcomes indicated significant time effects (ps < .001) and no significant group-by-time interactions (ps from .07 to .91) on other sleep diary parameters, sleep medication use, depression, anxiety, fatigue, and quality of life scores. CONCLUSION(S): The efficacy of stepped care CBT-I is not inferior to that of a standard face-to-face intervention and is a valuable approach to making this treatment more widely accessible to cancer patients.

trial registrationClinicalTrials.gov Identifier: NCT01864720 (https://clinicaltrials.gov/ct2/show/NCT01864720?term=Savard&draw=2&rank=6; Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients).

Indexed as

Cognitive Behavioral TherapyNeoplasmsSleep Initiation and Maintenance DisordersAnxietyFatigueHumansTreatment Outcomecancercognitive-behavioral therapyinsomniasleepstepped careweb-based intervention

Identifiers

PMID34228123
PMCPMC8598200
OpenAlexW3183047821

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.