Evidence map›Paper›PMID 37968619›Full record

ArticleBMC psychiatry2023

Cognitive Remediation in Bipolar (CRiB2): study protocol for a randomised controlled trial assessing efficacy and mechanisms of cognitive remediation therapy compared to treatment as usual.

Dimosthenis Tsapekos, Rebecca Strawbridge, Matteo Cella, Kimberley Goldsmith, Michail Kalfas, Rosie H Taylor, Samuel Swidzinski, Steven Marwaha, Libby Grey, Elizabeth Newton and 9 more

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

Article in BMC psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% 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, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  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

19 authors at 8 institutions in 1 country.

Dimosthenis TsapekosDepartment of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 103 Denmark Hill, London, SE5 8AZ, UK. dimosthenis.tsapekos@kcl.ac.uk.
Rebecca StrawbridgeDepartment of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 103 Denmark Hill, London, SE5 8AZ, UK.
Matteo CellaDepartment of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Kimberley GoldsmithDepartment of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Michail KalfasDepartment of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 103 Denmark Hill, London, SE5 8AZ, UK.
Rosie H TaylorDepartment of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 103 Denmark Hill, London, SE5 8AZ, UK.
Samuel SwidzinskiDepartment of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 103 Denmark Hill, London, SE5 8AZ, UK.
Steven MarwahaInstitute for Mental Health, University of Birmingham, Edgbaston, Birmingham, UK.
Libby GreyInstitute for Mental Health, University of Birmingham, Edgbaston, Birmingham, UK.
Elizabeth NewtonBirmingham and Solihull Mental Health NHS Foundation Trust, Birmingham, UK.
Julie ShackletonBirmingham and Solihull Mental Health NHS Foundation Trust, Birmingham, UK.
Paul J HarrisonDepartment of Psychiatry, University of Oxford, Oxford, UK.
Michael BrowningDepartment of Psychiatry, University of Oxford, Oxford, UK.
Catherine HarmerDepartment of Psychiatry, University of Oxford, Oxford, UK.
Hannah HartlandDepartment of Psychiatry, University of Oxford, Oxford, UK.
David CousinsFaculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne, UK.
Stephen BartonCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.
Til WykesDepartment of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Allan H YoungDepartment of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 103 Denmark Hill, London, SE5 8AZ, UK.
King's College London · GBUniversity of Oxford · GBBirmingham and Solihull Mental Health NHS Foundation Trust · GBCumbria Northumberland Tyne and Wear NHS Foundation Trust · GBUniversity of Birmingham · GBBethlem Royal Hospital · GBKing's College School · GBOxford Health NHS Foundation Trust · GB

Funding

Department of Health NIHR132619Wellcome Trust
6 · The paper itself

Abstract

backgroundA substantial proportion of people with bipolar disorder (BD) experience persistent cognitive difficulties associated with impairments in psychosocial functioning and a poorer disorder course. Emerging evidence suggests that cognitive remediation (CR), a psychological intervention with established efficacy in people with schizophrenia, can also benefit people with BD. Following a proof-of-concept trial showing that CR is feasible and potentially beneficial for people with BD, we are conducting an adequately powered trial in euthymic people with BD to 1) determine whether an individual, therapist-supported, computerised CR can reduce cognitive difficulties and improve functional outcomes; and 2) explore how CR exerts its effects.

methodsCRiB2 is a two-arm, assessor-blind, multi-site, randomised controlled trial (RCT) comparing CR to treatment-as-usual (TAU). Participants are people with a diagnosis of BD, aged between 18 and 65, with no neurological or current substance use disorder, and currently euthymic. 250 participants will be recruited through primary, secondary, tertiary care, and the community. Participants will be block-randomised (1:1 ratio, stratified by site) to continue with their usual care (TAU) or receive a 12-week course of therapy and usual care (CR + TAU). The intervention comprises one-on-one CR sessions with a therapist supplemented with independent cognitive training for 30-40 h in total. Outcomes will be assessed at 13- and 25-weeks post-randomisation. Efficacy will be examined by intention-to-treat analyses estimating between-group differences in primary (i.e., psychosocial functioning at week 25 measured with the Functional Assessment Short Test) and secondary outcomes (i.e., measures of cognition, mood, patient-defined goals, and quality of life). Global cognition, metacognitive skills, affect fluctuation, and salivary cortisol levels will be evaluated as putative mechanisms of CR through mediation models. DISCUSSION: This study will provide a robust evaluation of efficacy of CR in people with BD and examine the putative mechanisms by which this therapy works. The findings will contribute to determining the clinical utility of CR and potential mechanisms of action.

trial registrationCognitive Remediation in Bipolar 2 (CRiB2): ISRCTN registry: https://www.isrctn.com/ISRCTN10362331 . Registered 04 May 2022. Overall trial status: Ongoing; Recruitment status: Recruiting.

Indexed as

Bipolar DisorderCognitive Behavioral TherapyCognitive RemediationAdolescentAdultAffectAgedCognitionHumansMiddle AgedRandomized Controlled Trials as TopicTreatment OutcomeYoung AdultBipolar disorder (BD)Cognitive remediation (CR)EfficacyMechanismsRandomised controlled trial (RCT)Trial protocol

Identifiers

PMID37968619
PMCPMC10652583
OpenAlexW4388696551

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.