Evidence map›Paper›PMID 35701842›Full record

ArticlePilot and feasibility studies2022

Efficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trial.

Kevin K N Ho, Milena Simic, Marina B Pinheiro, Christopher B Miller, Manuela L Ferreira, Ronald R Grunstein, John L Hopper, Juan R Ordoñana, Paulo H Ferreira

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2022. 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
1.1field-weighted citation impact, top 22% 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, 6 citations in OpenAlex.

  1. Trial
  2. Article
  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

9 authors at 4 institutions in 4 countries.

Kevin K N HoFaculty of Medicine and Health, The University of Sydney, Susan Wakil Health Building, Sydney, NSW, 2050, Australia. kevin.ho@sydney.edu.au.ORCID http://orcid.org/0000-0003-2438-3467
Milena SimicFaculty of Medicine and Health, The University of Sydney, Susan Wakil Health Building, Sydney, NSW, 2050, Australia.
Marina B PinheiroFaculty of Medicine and Health, The University of Sydney, Susan Wakil Health Building, Sydney, NSW, 2050, Australia.
Christopher B MillerBig Health Inc., San Francisco, USA.
Manuela L FerreiraInstitute of Bone and Joint Research, The Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
Ronald R GrunsteinCIRUS, Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia.
John L HopperCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.
Juan R OrdoñanaMurcia Twin Registry, Department of Human Anatomy and Psychobiology, University of Murcia, and IMIB-Arrixaca, Murcia, Spain.
Paulo H FerreiraFaculty of Medicine and Health, The University of Sydney, Susan Wakil Health Building, Sydney, NSW, 2050, Australia.
The University of Sydney · AUThe University of Melbourne · AUUniversidad de Murcia · ESUniversity of Oxford · GB

Funding

National Health and Medical Research Council 1106974
6 · The paper itself

Abstract

backgroundDigital cognitive behavioral therapy for insomnia (CBT-i) in people with low back pain (LBP) may be efficacious in improving both sleep and pain; and twin trial designs provide greater precision of treatment effects by accounting for genetic and early environmental factors. We aimed to determine the feasibility of a trial investigating the efficacy of a digital CBT-i program in people with comorbid symptoms of insomnia and LBP, in twins and people from the general community (singletons).

methodsThirty-two twins (16 pairs) and 66 singletons with comorbid symptoms of insomnia and LBP (> 6 weeks duration) were randomized to digital CBT-i (intervention) or educational program (control) for 6 weeks. The digital CBT-I, Sleepio (developed by Big Health Inc.), was an online interactive, automated, personalized course comprising of six sessions, once a week. The education program was six emails with general sleep information, once a week. Participants were blinded to their group allocation and offered the alternative intervention at the completion of the study. Feasibility outcomes included recruitment and follow-up rates, data collection and outcome measure completion, contamination (communication about trial interventions), acceptability (adherence), credibility, and participants' experience of the intervention.

resultsSixteen out of 722 contacted twin pairs were recruited (recruitment rate = 2.2%). Twins were recruited between September 2015 and August 2018 (35 months) and singletons between October 2017 and Aug 2018 (10 months). Follow-up rates for post-intervention and 3-month follow-up were 81% and 72% for twins and 82% and 78% for singletons respectively. Adherence rates (percentage of sessions completed out of six) for the digital CBT-i were 63% for twins and 55% for singletons. Contamination (speaking about the study to each other) was present in two twin pairs (13%). Written or verbal feedback (n = 21) regarding the digital CBT-i intervention from participants were positive (n = 11), neutral (n = 5), or negative (n = 6).

conclusionsOnline CBT-i was received favorably with people with comorbid symptoms of insomnia and LBP. While the online data collection was successful, strategies need to be implemented to improve adherence, follow-up, control group credibility (for digital CBT-i), and twin recruitment rates (for twin trials).

trial registrationAustralian New Zealand Clinical Trials Registry ( ACTRN12615000672550 ). Registered 29 June 2015.

Indexed as

DigitalInsomniaLow back painRandomized control trialSleepTwins

Identifiers

PMID35701842
PMCPMC9195289
OpenAlexW4282835364

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.