Evidence map›Paper›PMID 37428712›Full record

Trial reportSleep2023

The clinical effects of digital cognitive behavioral therapy for insomnia in a heterogenous study sample: results from a randomized controlled trial.

Jennifer Schuffelen, Leonie F Maurer, Noah Lorenz, Alexander Rötger, Reinhard Pietrowsky, Annika Gieselmann

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Sleep, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06926348 (Usability, Acceptability, and Preliminary Effectiveness of a Digital Health Technology for Patient Monitoring of Chronic Insomnia Symptoms and the Promotion of Functional Sleep Behaviors), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
9.0field-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.

NCT06926348 narecruitingnot on this mapstarted 2025, after this paper: background citation

Usability, Acceptability, and Preliminary Effectiveness of a Digital Health Technology for Patient Monitoring of Chronic Insomnia Symptoms and the Promotion of Functional Sleep Behaviors: A Randomized Clinical Trial

TypeinterventionalSponsorUniversita di VeronaRan2025 to 2026Enrolled50ConditionsInsomnia Chronic, InsomniaArmsDigital Health Technology for Chronic Insomnia, Treatment as Usual (TAU)
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

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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

6 authors at 1 institution in 1 country.

Jennifer SchuffelenHeinrich Heine University Düsseldorf, Institute of Experimental Psychology, Department of Clinical Psychology, GermanyGermany.
Leonie F Maurermementor DE GmbH, Department of Science, Germany.ORCID 0000-0001-7335-2320
Noah Lorenzmementor DE GmbH, Department of Science, Germany.
Alexander Rötgermementor DE GmbH, Department of Science, Germany.
Reinhard PietrowskyHeinrich Heine University Düsseldorf, Institute of Experimental Psychology, Department of Clinical Psychology, GermanyGermany.
Annika GieselmannHeinrich Heine University Düsseldorf, Institute of Experimental Psychology, Department of Clinical Psychology, GermanyGermany.ORCID 0000-0002-7797-6437
Heinrich Heine University Düsseldorf · DE

Funding

Mementor DE GmbH
6 · The paper itself

Abstract

STUDY

objectivesNumerous studies worldwide have reported the beneficial effects of digital cognitive behavioral therapy for insomnia (dCBT-I). However, few focus on real-world study samples that reflect people in regular care. To test whether dCBT-I is suitable within German regular care, we designed a randomized controlled trial recruiting a heterogenous insomnia population.

methodsParticipants aged ≥18 who met the criteria for insomnia disorder were randomized to 8-weeks dCBT-I + care-as-usual (CAU) or they were set on a waitlist + CAU. The intervention group was followed-up at 6- and 12-months. The primary outcome was self-reported insomnia severity, assessed with the Insomnia Severity Index (ISI) at 8-weeks post-randomization. A one-way ANCOVA with baseline score as a covariate was fitted to determine group differences. Secondary outcomes included measures of daytime functioning, quality of life, depression, anxiety, dreams, and nightmares.

resultsOf the N = 238 participants (67.6% female), age range 19-81 years, n = 118 were randomized to dCBT-I and n = 120 to the control group. At posttreatment, the use of dCBT-I was associated with a large reduction in the ISI (Diffadj = -7.60) in comparison to WLC (d = -2.08). This clinical improvement was also reflected in responder and remission rates. Treatment effects were also observed for daytime functioning, quality of life, symptoms of depression and anxiety (ds = 0.26-1.02) and at long-term follow-up (intervention group only; ds = 0.18-1.65). No effects were found for dream and nightmare frequency.

conclusionsThis study showed that dCBT-I reduces insomnia symptoms and improves daytime functioning in a heterogenous insomnia population in Germany with sustained long-term treatment effects in the intervention group. Our results underscore the potential of digital health applications, their suitability within regular care, and their role in facilitating widespread implementation of CBT-I as a first-line treatment for insomnia.

Indexed as

Cognitive Behavioral TherapySleep Initiation and Maintenance DisordersAdultAgedAged, 80 and overDreamsFemaleHumansMaleMiddle AgedQuality of LifeTreatment OutcomeYoung AdultCBT-Icognitive behavioral therapy for insomniadCBT-Idigital healthdigital therapyinsomniarandomized controlled trialRCTregular caresleep

Identifiers

PMID37428712
PMCPMC10636251
OpenAlexW4383720405

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.