Evidence map›Paper›PMID 35922096›Full record

ArticleBMJ open2022

Comparative effectiveness of three versions of a stepped care model for insomnia differing in the amount of therapist support in internet-delivered treatment: study protocol for a pragmatic cluster randomised controlled trial (GET Sleep).

Kai Spiegelhalder, Harald Baumeister, Abdulwahab Al-Kamaly, Martina Bader, Natalie Bauereiss, Fee Benz, Lina Braun, Claudia Buntrock, Maike Burkhardt, Pim Cuijpers and 21 more

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

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

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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

31 authors.

Kai Spiegelhalder *Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany Kai.Spiegelhalder@uniklinik-freiburg.de.ORCID 0000-0002-4133-3464
Harald Baumeister *Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.
Abdulwahab Al-KamalyDepartment of Medicine, Institute of General Practice/Family Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Martina BaderDepartment of Psychological Research Methods, Institute of Psychology and Education, Ulm University, Ulm, Germany.
Natalie BauereissDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.
Fee BenzDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Lina BraunDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.
Claudia BuntrockDepartment of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.ORCID 0000-0002-4974-5455
Maike BurkhardtBARMER, Schwäbisch-Gmünd, Germany.
Pim CuijpersDepartment of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0001-5497-2743
Katharina DomschkeDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Patrick DülsenDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.
Marvin FrankeDepartment of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.
Lukas FraseDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Elena HeberGET.ON Institut für Online Gesundheitstrainings GmbH (operating under the registered brand 'HelloBetter'), Hamburg, Germany.
Kathrin HelmDepartment of Medicine, Institute of General Practice/Family Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Terry JentschDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Anna JohannDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Ann-Marie KüchlerDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.
Michael KuhnBARMER, Schwäbisch-Gmünd, Germany.
Dirk LehrDepartment of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Lueneburg, Germany.
Andy MaunDepartment of Medicine, Institute of General Practice/Family Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Charles M MorinÉcole de psychologie, Université Laval, Québec City, Québec, Canada.
Morten MoshagenDepartment of Psychological Research Methods, Institute of Psychology and Education, Ulm University, Ulm, Germany.ORCID 0000-0002-2929-7288
Kneginja RichterUniversity Clinic for Psychiatry and Psychotherapy, Paracelsus Medical University, Nuremberg, Germany.
Julian SchielDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Laura SimonDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.
Lukas SpilleDepartment of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Hans-Günter WeeßInterdisciplinary Center of Sleep, Pfalzklinikum, Klinikum für Psychiatrie und Neurologie AdöR, Klingenmünster, Germany.
Dieter Riemann *Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
David Daniel Ebert *GET.ON Institut für Online Gesundheitstrainings GmbH (operating under the registered brand 'HelloBetter'), Hamburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIt is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I. METHODS AND ANALYSIS: In this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Medical Centre-University of Freiburg. The results of the study will be published irrespective of the outcome. TRIAL REGISTRATION NUMBER: DRKS00021503.

Indexed as

Cognitive Behavioral TherapySleep Initiation and Maintenance DisordersHumansInternetPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSleepTreatment OutcomeAdult psychiatryPSYCHIATRYSLEEP MEDICINE

Identifiers

PMID35922096
PMCPMC9353010

What OpenQuestion holds

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LicenceCC BY-NC
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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.