Evidence map›Paper›PMID 38858707›Full record

ArticleTrials2024

Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial (iSleep well).

F Benz, L Grolig, S Hannibal, C Buntrock, P Cuijpers, K Domschke, D D Ebert, J Ell, M Janneck, C Jenkner and 16 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. 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

26 authors.

F Benz *Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. fee.benz@uniklinik-freiburg.de.ORCID http://orcid.org/0000-0002-8394-9179
L Grolig *Department of Health Psychology and Applied Biological Psychology, Institute of Sustainability Psychology, Leuphana University of Lüneburg, Lüneburg, Germany.
S HannibalDepartment of Health Psychology and Applied Biological Psychology, Institute of Sustainability Psychology, Leuphana University of Lüneburg, Lüneburg, Germany.
C BuntrockInstitute of Social Medicine and Health Systems Research, Medical Faculty, Otto-von-Guericke-University, Magdeburg, Germany.
P CuijpersDepartment of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
K DomschkeDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
D D EbertPsychology & Digital Mental Health Care, Department of Health Sciences, Technical University Munich, Munich, Germany.
J EllDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
M JanneckInstitute for Interactive Systems, Department of Electrical Engineering and Computer Science, Technische Hochschule Lübeck, Lübeck, Germany.
C JenknerClinical Trials Unit, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
A F JohannDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
A JosefClinical Trials Unit, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
M KaufmannClinical Trials Unit, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
A KoßClinical Trials Unit, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
T MallwitzInstitute for Interactive Systems, Department of Electrical Engineering and Computer Science, Technische Hochschule Lübeck, Lübeck, Germany.
H MerganInstitute for Interactive Systems, Department of Electrical Engineering and Computer Science, Technische Hochschule Lübeck, Lübeck, Germany.
C M MorinÉcole de Psychologie, Centre d'étude des troubles du sommeil, Centre de recherche CERVO/Brain Research Center, Université Laval, Québec, Canada.
D RiemannDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
H RiperDepartment of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
S R SchmidDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
F SmitDepartment of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
L SpilleDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
L SteinmetzDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
E J W Van SomerenDepartment of Sleep and Cognition, Netherlands Institute for Neuroscience, Royal Netherlands Academy of Arts and Sciences, Amsterdam, the Netherlands.
K Spiegelhalder *Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
D Lehr *Department of Health Psychology and Applied Biological Psychology, Institute of Sustainability Psychology, Leuphana University of Lüneburg, Lüneburg, Germany.

Funding

Deutsche Forschungsgemeinschaft 422022593
6 · The paper itself

Abstract

backgroundInsomnia is a highly prevalent disorder associated with numerous adverse health outcomes. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment by clinical guidelines but is accessible to only a minority of patients suffering from insomnia. Internet-delivered CBT-I (iCBT-I) could contribute to the widespread dissemination of this first-line treatment. As there is insufficient evidence regarding non-inferiority, this study directly aims to compare therapist-guided internet-delivered versus face-to-face CBT-I in terms of insomnia severity post-treatment. Furthermore, a health-economic evaluation will be conducted, and potential benefits and disadvantages of therapist-guided iCBT-I will be examined.

methodsThis study protocol describes a randomised controlled two-arm parallel-group non-inferiority trial comparing therapist-guided iCBT-I with face-to-face CBT-I in routine clinical care. A total of 422 patients with insomnia disorder will be randomised and treated at 16 study centres throughout Germany. Outcomes will be assessed at baseline, 10 weeks after randomisation (post), and 6 months after randomisation (follow-up). The primary outcome is insomnia severity measured using the Insomnia Severity Index. Secondary outcomes include depression-related symptoms, quality of life, fatigue, physical activity, daylight exposure, adverse events related to treatment, and a health-economic evaluation. Finally, potential moderator variables and several descriptive and exploratory outcomes will be assessed (e.g. benefits and disadvantages of internet-delivered treatment). DISCUSSION: The widespread implementation of CBT-I is a significant healthcare challenge. The non-inferiority of therapist-guided iCBT-I versus face-to-face CBT-I will be investigated in an adequately powered sample in routine clinical care, with the same therapeutic content and same level of therapist qualifications provided with both interventions. If this trial demonstrates the non-inferiority of therapist-guided iCBT-I, healthcare providers may be more confident recommending this treatment to their patients, contributing to the wider dissemination of CBT-I.

trial registrationTrial registration number in the German Clinical Trials Register: DRKS00028153 ( https://drks.de/search/de/trial/DRKS00028153 ). Registered on 16th May 2023.

Indexed as

Cognitive Behavioral TherapySleep Initiation and Maintenance DisordersCost-Benefit AnalysisEquivalence Trials as TopicGermanyHumansInternetInternet-Based InterventionMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicSeverity of Illness IndexTime FactorsTreatment OutcomeCBT-ICognitive behavioural therapy for insomniaDigitalFace-to-faceGuided internet interventionInsomniaInternet-deliveredNon-inferiority trialRandomised controlled trial

Identifiers

PMID38858707
PMCPMC11163861

What OpenQuestion holds

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Registered trials

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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.