Evidence map›Paper›PMID 32471477›Full record

ArticleTrials2020

Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial.

K M Latocha, K B Løppenthin, M Østergaard, P J Jennum, R Christensen, M Hetland, H Røgind, T Lundbak, J Midtgaard, B A Esbensen

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03766100 (The Efficacy of Cognitive Behavioural Therapy for Insomnia), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

NCT03766100 nacompletednot on this map

The Efficacy of Cognitive Behavioural Therapy for Insomnia (CBT-I) on Sleep in Patients With Rheumatoid Arthritis: the Randomised, Non-blinded, Parallel-group Sleep-RA Trial.

TypeinterventionalSponsorBente Appel EsbensenRan2018 to 2021Enrolled62ConditionsRheumatoid Arthritis, InsomniaArmsCognitive behavioural therapy (CBT-i)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
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  8. A concept elicitation study to understand the relationship between sleep and pain in rheumatoid arthritis and axial spondyloarthritis.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024
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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

10 authors at 3 institutions in 1 country.

K M LatochaCopenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark. kristine.marie.latocha@regionh.dk.
K B LøppenthinDepartment of Oncology, Research unit for Cancer Late Effect, CASTLE, Rigshospitalet, Copenhagen, Denmark.
M ØstergaardCopenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
P J JennumDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
R ChristensenMusculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark.
M HetlandCopenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
H RøgindCenter for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
T LundbakCenter for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
J MidtgaardThe University Hospitals Centre for Health Research, Rigshospitalet, Copenhagen, Denmark.
B A EsbensenCopenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.
Rigshospitalet · DKGlostrup Hospital · DKUniversity of Southern Denmark · DK

Funding

Danish Rheumatism Association R153-A4718Novo Nordisk Fonden (DK) NNF15OC0018194Rigshospitalet E-23241-06
6 · The paper itself

Abstract

backgroundMore than half of patients with rheumatoid arthritis complain of insomnia, which is predominantly treated with hypnotic drugs. However, cognitive behavioural therapy for insomnia is recommended as the first-line treatment in international guidelines on sleep. Patients with rheumatoid arthritis suffer from debilitating symptoms, such as fatigue and pain, which can also be linked to sleep disturbance. It remains to be determined whether cognitive behavioural therapy for insomnia can be effective in patients with rheumatoid arthritis. The aim of the Sleep-RA trial is to investigate the efficacy of cognitive behavioural therapy for insomnia on sleep and disease-related symptoms in patients with rheumatoid arthritis. The primary objective is to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep efficiency from baseline to week 7 in patients with rheumatoid arthritis. The key secondary objectives are to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep onset latency, wake after sleep onset, total sleep time, insomnia, sleep quality, fatigue, impact of rheumatoid arthritis and depressive symptoms from baseline to week 26 in patients with rheumatoid arthritis.

methodsThe Sleep-RA trial is a randomised controlled trial with a two-group parallel design. Sixty patients with rheumatoid arthritis, insomnia and low-to-moderate disease activity will be allocated 1:1 to treatment with cognitive behavioural therapy for insomnia or usual care. Patients in the intervention group will receive nurse-led, group-based cognitive behavioural therapy for insomnia once a week for 6 weeks. Outcome assessments will be carried out at baseline, after treatment (week 7) and at follow-up (week 26). DISCUSSION: Data on treatment of insomnia in patients with rheumatoid arthritis are sparse. The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis. Because symptoms of rheumatoid arthritis and insomnia have many similarities, we also find it relevant to investigate the secondary effects of cognitive behavioural therapy for insomnia on fatigue, impact of rheumatoid arthritis, depressive symptoms, pain, functional status, health-related quality of life and disease activity. If we find cognitive behavioural therapy for insomnia to be effective in patients with rheumatoid arthritis this will add weight to the argument that evidence-based non-pharmacological treatment for insomnia in rheumatological outpatient clinics is eligible in accordance with the existing international guidelines on sleep.

trial registrationClinicalTrials.gov: NCT03766100. Registered on 30 November 2018.

Indexed as

Arthritis, RheumatoidCognitive Behavioral TherapyDenmarkDepressionFatigueHumansMulticenter Studies as TopicPsychotherapy, GroupQuality of LifeRandomized Controlled Trials as TopicSingle-Blind MethodSleepSleep Initiation and Maintenance DisordersTime FactorsTreatment OutcomeActigraphyCognitive behavioural therapy for insomniaFatigueHealth-related quality of lifeImpact of rheumatoid arthritisInflammatory arthritisInsomniaNon-pharmacological treatmentPolysomnographySleep disturbance

Identifiers

PMID32471477
PMCPMC7257190
OpenAlexW3032849252

What OpenQuestion holds

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LicenceCC BY
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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.