Evidence map›Paper›PMID 30208971›Full record

ArticleTrials2018

Effect of action-based cognitive remediation on cognition and neural activity in bipolar disorder: study protocol for a randomized controlled trial.

Caroline V Ott, Maj Vinberg, Christopher R Bowie, Ellen Margrethe Christensen, Gitte M Knudsen, Lars V Kessing, Kamilla W Miskowiak

Erratum issued Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03295305 (Effect of Action-Based Cognitive Remediation on Cognition and Frontal Lobe Activity in Patients With Bipolar Disorder in Remission), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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.

NCT03295305 nacompletednot on this map

Effect of Action-Based Cognitive Remediation on Cognition and Frontal Lobe Activity in Patients With Bipolar Disorder in Remission (PRETEC-ABC)

TypeinterventionalSponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalRan2017 to 2020Enrolled64ConditionsBipolar Disorder, Cognitive ImpairmentArmsAction-Based Cognitive Remediation, Unstructured support group
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Change in prefrontal activity and executive functions after action-based cognitive remediation in bipolar disorder: a randomized controlled trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2021
    Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Improving Functioning, Quality of Life, and Well-being in Patients With Bipolar Disorder.The international journal of neuropsychopharmacology · 2019
    Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Caroline V OttCopenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Maj VinbergCopenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Christopher R BowiePsychology Department, Queen's University, Kingston, ON, Canada.
Ellen Margrethe ChristensenCopenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Gitte M KnudsenNeurobiology Research Unit and Center for Experimental Medicine Neuropharmacology, Rigshospitalet, Copenhagen, Denmark.
Lars V KessingCopenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Kamilla W MiskowiakCopenhagen Affective Disorder Research Center (CADIC), Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. kamilla.woznica.miskowiak@regionh.dk.

Funding

Lundbeckfonden R215-2015-4121
6 · The paper itself

Abstract

backgroundCognitive impairment is present in bipolar disorder (BD) during the acute and remitted phases and hampers functional recovery. However, there is currently no clinically available treatment with direct and lasting effects on cognitive impairment in BD. We will examine the effect of a novel form of cognitive remediation, action-based cognitive remediation (ABCR), on cognitive impairment in patients with BD, and explore the neural substrates of potential treatment efficacy on cognition. METHODS/

designThe trial has a randomized, controlled, parallel-group design. In total, 58 patients with BD in full or partial remission aged 18-55 years with objective cognitive impairment will be recruited. Participants are randomized to 10 weeks of ABCR or a control group. Assessments encompassing neuropsychological testing and mood ratings, and questionnaires on subjective cognitive complaints, psychosocial functioning, and quality of life are carried out at baseline, after 2 weeks of treatment, after the end of treatment, and at a six-month-follow-up after treatment completion. Functional magnetic resonance imaging scans are performed at baseline and 2 weeks into treatment. The primary outcome is a cognitive composite score spanning verbal memory, attention, and executive function. Two complete data sets for 52 patients will provide a power of 80% to detect a clinically relevant between-group difference on the primary outcome. Behavioral data will be analyzed using mixed models in SPSS while MRI data will be analyzed with the FMRIB Expert Analysis Tool (FEAT). Early treatment-related changes in neural activity from baseline to week 2 will be investigated for the dorsal prefrontal cortex and hippocampus as the regions of interest and with an exploratory whole-brain analysis. DISCUSSION: The results will provide insight into whether ABCR has beneficial effects on cognition and functioning in remitted patients with BD. The results will also provide insight into early changes in neural activity associated with improvement of cognition, which can aid future treatment development.

trial registrationClinicaltrials.gov , NCT03295305 . Registered on 26 September 2017.

Indexed as

Brain WavesCognitionAdolescentAdultAttentionBipolar DisorderBrainBrain MappingCognitive RemediationDenmarkExecutive FunctionFemaleHumansMagnetic Resonance ImagingMaleMemoryBiomarkerBipolar disorderCognitionCognitive impairmentCognitive remediationFunctional magnetic resonance imagingPro-cognitive effect

Identifiers

PMID30208971
PMCPMC6134776

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.