Evidence map›Paper›PMID 29196479›Full record

Trial reportBMJ open2017

Sleep Treatment Outcome Predictors (STOP) Pilot Study: a protocol for a randomised controlled trial examining predictors of change of insomnia symptoms and associated traits following cognitive-behavioural therapy for insomnia in an unselected sample.

Dan Denis, Thalia C Eley, Fruhling Rijsdijk, Helena M S Zavos, Robert Keers, Colin A Espie, Annemarie I Luik, Isabella Badini, Sarah Derveeuw, Alvin Romero and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03062891 (Sleep Treatment Outcome Predictors), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 21% 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.

NCT03062891 nacompletednot on this map

Sleep Treatment Outcome Predictors: A Pilot Study (STOP-pilot)

TypeinterventionalSponsorKing's College LondonRan2016 to 2017Enrolled240ConditionsSleep ProblemArmsOnline CBT for insomnia
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. 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 at 5 institutions in 2 countries.

Dan DenisDepartment of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0003-3740-7587
Thalia C EleyMRC Social, Genetic, and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.
Fruhling RijsdijkMRC Social, Genetic, and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.
Helena M S ZavosMRC Social, Genetic, and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.
Robert KeersSchool of Biological and Chemical Sciences, Queen Mary University of London, London, UK.
Colin A EspieSleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
Annemarie I LuikSleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
Isabella BadiniDepartment of Psychology, Goldsmiths, University of London, London, UK.
Sarah DerveeuwMRC Social, Genetic, and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.
Alvin RomeroSLaM BioResource for Mental Health, South London and Maudsley NHS Foundation Trust, King's College London, London, UK.
John HodsollDepartment of Biostatistics, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.
Alice M GregoryDepartment of Psychology, Goldsmiths, University of London, London, UK.
King's College London · GBGoldsmiths University of London · GBUniversity of Oxford · GBBeth Israel Deaconess Medical Center · USQueen Mary University of London · GB

Funding

Medical Research Council MR/K021281/1Medical Research Council MR/K021281/2
6 · The paper itself

Abstract

introductionCognitive-behavioural therapy for insomnia (CBT-I) leads to insomnia symptom improvements in a substantial proportion of patients. However, not everyone responds well to this treatment, and it is unclear what determines individual differences in response. The broader aim of this work is to examine to what extent response to CBT-I is due to genetic and environmental factors. The purpose of this pilot study is to examine feasibility of a design to test hypotheses focusing on an unselected sample, that is, without selection on insomnia complaints, in order to plan a larger behavioural genetics study where most participants will likely not have an insomnia disorder. METHODS AND ANALYSIS: A two parallel-group randomised controlled trial is being conducted across three London universities. Female students (minimum age 18 years) enrolled on a psychology programme at one of the three sites were invited to participate. The target number of participants to be recruited is 240. Following baseline assessments, participants were randomly allocated to either the treatment group, where they received weekly sessions of digital CBT-I for 6 weeks, or the control group, where they completed an online puzzle each week for 6 weeks. Follow-up assessments have taken place mid-intervention (3 weeks) and end of intervention (6 weeks). A 6-month follow-up assessment will also occur. Primary outcomes will be assessed using descriptive statistics and effect size estimates for intervention effects. Secondary outcomes will be analysed using multivariate generalised estimating equation models. ETHICS AND DISSEMINATION: The study received ethical approval from the Research Ethics and Integrity subcommittee, Goldsmiths, University of London (application reference: EA 1305). DNA sample collection for the BioResource received ethical approval from the NRES Committee South Central-Oxford (reference number: 15/SC/0388). The results of this work shall be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03062891; Results.

Indexed as

AdultCognitive Behavioral TherapyDNAFemaleHumansInternetPilot ProjectsResearch DesignSleep Initiation and Maintenance DisordersSurveys and QuestionnairesTherapy, Computer-AssistedTreatment OutcomeYoung AdultDNAadult psychiatrypsychiatrysleep medicine

Identifiers

PMID29196479
PMCPMC5719290
OpenAlexW2770551105

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.