Evidence map›Paper›PMID 33066812›Full record

ArticleTrials2020

A blended eHealth intervention for insomnia following acquired brain injury: study protocol for a randomized controlled trial.

Marthe E Ford, Gert J Geurtsen, Erny Groet, Coen A M Van Bennekom, Eus J W Van Someren

Open access · goldAbstract readClinical Trial Protocol
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. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.2field-weighted citation impact, top 41% 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.

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, 5 citations in OpenAlex.

  1. Trial
  2. Trial
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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

5 authors at 4 institutions in 1 country.

Marthe E FordDepartment of Psychology, Heliomare Rehabilitation, Wijk aan Zee, The Netherlands. m.e.ford@vu.nl.ORCID http://orcid.org/0000-0003-2918-6833
Gert J GeurtsenDepartment of Medical Psychology, Amsterdam UMC, location AMC, Amsterdam, The Netherlands.
Erny GroetDepartment of Psychology, Heliomare Rehabilitation, Wijk aan Zee, The Netherlands.
Coen A M Van BennekomDepartment of Medical Psychology, Amsterdam UMC, location AMC, Amsterdam, The Netherlands.
Eus J W Van SomerenDepartment of Sleep and Cognition, Netherlands Institute for Neuroscience, Amsterdam, The Netherlands.
Heliomare · NLAmsterdam University Medical Centers · NLNetherlands Center for Occupational Diseases · NLNetherlands Institute for Neuroscience · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUp to a third of stroke patients and patients with traumatic brain injury suffer from insomnia, including problems to fall asleep or stay asleep at night. Insomnia may exacerbate other brain damage-related problems, for example regarding cognitive functioning and emotional well-being; may lead to poorer quality of life; and may complicate recovery processes. Cognitive behavioral therapy for insomnia, delivered face-to-face or online, is found to be effective in the general population. However, despite the high prevalence and serious consequences of insomnia following acquired brain injury, studies on the efficacy of face-to-face cognitive behavioral treatment in this population are scarce, and this applies even more for studies on online cognitive behavioral therapy. Therefore, this study aims to evaluate the efficacy of a newly developed guided online cognitive behavioral therapy for insomnia following acquired brain injury.

methodsA multicenter, prospective, randomized, open-label, blinded end point study (PROBE) will be conducted, in which 48 patients diagnosed with stroke or traumatic brain injury and insomnia will be randomly allocated to the online cognitive behavioral therapy for insomnia treatment group or the treatment as usual group. The treatment consists of 6 online cognitive behavioral therapy sessions given on a weekly basis and personalized feedback after each session, combined with 2 face-to-face sessions. Outcomes will be assessed at baseline, immediately after the intervention period and at 6-week follow-up. The primary outcome is the insomnia severity assessed with the Insomnia Severity Index. Secondary outcome measures include sleep quality, sleep features derived from the sleep diary, fatigue, anxiety and depression, subjective cognitive functioning, and societal participation. DISCUSSION: This study will provide insight on the efficacy of online cognitive behavioral therapy for insomnia following stroke and traumatic brain injury.

trial registrationNetherlands Trial Register NTR7082 . Registered on 12 March 2018.

Indexed as

Brain InjuriesSleep Initiation and Maintenance DisordersTelemedicineHumansMulticenter Studies as TopicNetherlandsProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeAcquired brain injuryCognitive behavioral therapyeHealthInsomniaOnline treatmentSleepStrokeTraumatic brain injury

Identifiers

PMID33066812
PMCPMC7566121
OpenAlexW3093214391

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.