Evidence map›Paper›PMID 33637548›Full record

ArticleBMJ open2021

Open-label placebo for insomnia (OPIN): study protocol for a cohort multiple randomised controlled trial.

Ben Colagiuri, Louise Sharpe, Zahava Ambarchi, Nick Glozier, Delwyn Bartlett, Daniel S J Costa, Amelia Scott

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.4field-weighted citation impact, top 38% 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

0 citing papers in PubMed, 3 citations in OpenAlex.

No citing paper in PubMed yet.

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

7 authors at 1 institution in 1 country.

Ben ColagiuriSchool of Psychology, The University of Sydney, Sydney, New South Wales, Australia ben.colagiuri@sydney.edu.au.ORCID 0000-0003-2157-2641
Louise SharpeSchool of Psychology, The University of Sydney, Sydney, New South Wales, Australia.
Zahava AmbarchiSchool of Psychology, The University of Sydney, Sydney, New South Wales, Australia.
Nick GlozierBrain and Mind Centre, The University of Sydney, Sydney, New South Wales, Australia.
Delwyn BartlettWoolcock Institute, The University of Sydney, Sydney, New South Wales, Australia.
Daniel S J CostaSchool of Psychology, The University of Sydney, Sydney, New South Wales, Australia.
Amelia ScottSchool of Psychology, The University of Sydney, Sydney, New South Wales, Australia.
The University of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInsomnia is a prevalent sleep disorder that causes substantial personal and societal harm. There is evidence that placebo interventions can reduce insomnia symptoms, but this research has involved deceptively administering the placebo under the guise of a real medication (conventional placebo, CP), which has obvious ethical constraints. Open-label placebo (OLP) treatment, in which a placebo is administered with full disclosure that there are no active ingredients, has been proposed as a method of using the placebo effect ethically, but the efficacy and acceptability of OLP for insomnia is currently unknown. METHODS AND ANALYSIS: This study uses a cohort multiple randomised controlled trial design to compare OLP, CP and no treatment for insomnia. Two-hundred and sixty-seven participants with self-reported insomnia symptoms (Insomnia Severity Index, ISI ≥10) will be recruited into an observational study and have their sleep monitored over a 2-week period. Participants will then be randomised to one of three groups: invite to OLP, invite to CP described deceptively as a new pharmacological agent, or no invite/observational control. Those in OLP and CP accepting the invite receive identical placebos for a 2-week treatment period while sleep is monitored in all participants. The primary outcome is ISI at the end of the treatment period. Secondary outcomes include treatment uptake and clinically significant response rates, objective and subjective sleep parameters, fatigue, mood, expectancy, treatment satisfaction and side effects. Predictors of uptake and responses to OLP and CP will be explored. ETHICS AND DISSEMINATION: The trial has been approved by The University of Sydney Human Research Ethics Committee. Written informed consent is obtained from every participant. OLP and CP participants accepting the invite undergo an additional consent process. Results will be disseminated via peer-reviewed conference proceedings and publications. TRIAL REGISTRATION NUMBER: ACTRN12620001080910.

Indexed as

Sleep Initiation and Maintenance DisordersCohort StudiesHumansObservational Studies as TopicRandomized Controlled Trials as TopicResearch DesignSleepTreatment Outcomeclinical trialspsychiatrysleep medicine

Identifiers

PMID33637548
PMCPMC7919597
OpenAlexW3132359469

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.