Evidence map›Paper›PMID 33964166›Full record

Trial reportSleep2021

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT.

Cecilie L Vestergaard, Øystein Vedaa, Melanie R Simpson, Patrick Faaland, Daniel Vethe, Kaia Kjørstad, Knut Langsrud, Lee M Ritterband, Børge Sivertsen, Tore C Stiles and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 NCT02558647 (Overcoming Insomnia), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT02558647 naunknown statusnot on this map

Overcoming Insomnia: A Large-scale Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia Compared With Online Patient Education About Sleep.

TypeinterventionalSponsorNorwegian Institute of Public HealthRan2016 to 2021Enrolled1,500ConditionsInsomniaArmsCBT for insomnia (CBT-I), Psycho-Education about Sleep (PE)
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Caregivers' Internet-Delivered Insomnia Intervention Engagement and Benefit: SHUTi-CARE Trial Primary Quantitative Analysis.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2024
    Trial
  4. Review
  5. Article
  6. Caregiver Experiences With an Internet-Delivered Insomnia Intervention: SHUTi-CARE Trial Primary Qualitative Analysis.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2024
    Article
  7. Article
  8. Article
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

12 authors.

Cecilie L VestergaardDepartment of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0002-4185-6599
Øystein VedaaDepartment of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.
Melanie R SimpsonDepartment of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.
Patrick FaalandDepartment of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.
Daniel VetheDepartment of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0001-5028-3457
Kaia KjørstadDepartment of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.
Knut LangsrudSt. Olavs University Hospital, Østmarka, Trondheim, Norway.
Lee M RitterbandCenter for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, VA, USA.
Børge SivertsenDepartment of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0003-4654-9296
Tore C StilesDepartment of Psychology, Norwegian University of Science and Technology, Norway.
Jan ScottDepartment of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0002-7203-8601
Håvard KallestadDepartment of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.ORCID 0000-0002-9173-942X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesDigital cognitive behavioral therapy for insomnia (dCBT-I) is an effective treatment for insomnia. However, less is known about mediators of its benefits. The aim of the present study was to test if intraindividual variability in sleep (IIV) was reduced with dCBT-I, and whether any identified reduction was a mediator of dCBT-I on insomnia severity and psychological distress.

methodsIn a two-arm randomized controlled trial (RCT), 1720 adults with insomnia (dCBT-I = 867; patient education about sleep = 853) completed the Insomnia Severity Index (ISI), the Hospital Anxiety and Depression Scale (HADS) and sleep diaries, at baseline and 9-week follow-up. Changes in IIV were analyzed using linear mixed modeling followed by mediation analyses of ISI, HADS, and IIV in singular sleep metrics and composite measures (behavioral indices (BI-Z) and sleep disturbance indices (SI-Z)).

resultsdCBT-I was associated with reduced IIV across all singular sleep metrics, with the largest between-group effect sizes observed for sleep onset latency (SOL). Reduced IIV for SOL and wake after sleep onset had the overall greatest singular mediating effect. For composite measures, SI-Z mediated change in ISI (b = -0.74; 95% confidence interval (CI) -1.04 to -0.52; 13.3%) and HADS (b = -0.40; 95% CI -0.73 to -0.18; 29.2%), while BI-Z mediated minor changes.

conclusionReductions in IIV in key sleep metrics mediate significant changes in insomnia severity and especially psychological distress when using dCBT-I. These findings offer important evidence regarding the therapeutic action of dCBT-I and may guide the future development of this intervention. CLINICAL TRIALS: Name: Overcoming Insomnia: Impact on Sleep, Health and Work of Online CBT-I Registration number: NCT02558647 URL: https://clinicaltrials.gov/ct2/show/NCT02558647?cond=NCT02558647&draw=2&rank=1.

Indexed as

Cognitive Behavioral TherapySleep Initiation and Maintenance DisordersAdultHumansMediation AnalysisSleepTreatment OutcomeCBT-Iintraindividual variabilitymediation analysisrandomized controlled trialsleep–wake cycle

Identifiers

PMID33964166
PMCPMC8503826

What OpenQuestion holds

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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.