Evidence map›Paper›PMID 26969299›Full record

Trial reportTrials2016

Cognitive remediation versus active computer control in bipolar disorder with psychosis: study protocol for a randomized controlled trial.

Kathryn Eve Lewandowski, Sarah H Sperry, Dost Ongur, Bruce M Cohen, Lesley A Norris, Matcheri S Keshavan

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01470781 (Efficacy of a Cognitive Remediation Treatment Program for Bipolar Disorder), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT01470781 nacompletednot on this map

Efficacy of a Cognitive Remediation Treatment Program for Bipolar Disorder

TypeinterventionalSponsorMclean HospitalRan2011 to 2016Enrolled72ConditionsBipolar Disorder, PsychosisArmsBrainWorks, Computer Control
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design.Alzheimer's & dementia (New York, N. Y.) · 2022
    Article
  2. Cognitive Impairment in Bipolar Disorder: Treatment and Prevention Strategies.The international journal of neuropsychopharmacology · 2017
    Review
  3. Review
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

6 authors.

Kathryn Eve LewandowskiMcLean Hospital/Harvard Medical School, 115 Mill St., Belmont, MA, 02478, USA. klewandowski@mclean.harvard.edu.
Sarah H SperryMcLean Hospital/Harvard Medical School, 115 Mill St., Belmont, MA, 02478, USA.
Dost OngurMcLean Hospital/Harvard Medical School, 115 Mill St., Belmont, MA, 02478, USA.
Bruce M CohenMcLean Hospital/Harvard Medical School, 115 Mill St., Belmont, MA, 02478, USA.
Lesley A NorrisMcLean Hospital/Harvard Medical School, 115 Mill St., Belmont, MA, 02478, USA.
Matcheri S KeshavanBeth Israel Deaconess Medical Center/Harvard Medical School, 75 Fenwood Rd., Boston, MA, 02115, USA.

Funding

Probing the White Matter in Schizophrenia Using Novel MRS TechniquesR01MH094594 · NIMH · MCLEAN HOSPITAL · PI ONGUR, DOST · 2011 to 2015
$1.8M
Efficacy of a Cognitive Remediation Treatment Program for Bipolar DisorderK23MH091210 · NIMH · MCLEAN HOSPITAL · PI LEWANDOWSKI, KATHRYN EVE · 2011 to 2015
$749k
NIMH NIH HHS K23 MH091210NIMH NIH HHS K23MH91210NIMH NIH HHS R01 MH094594NIMH NIH HHS R01MH094594
6 · The paper itself

Abstract

backgroundCognitive dysfunction is a major feature of bipolar disorder with psychosis and is strongly associated with functional outcomes. Computer-based cognitive remediation has shown promise in improving cognition in patients with schizophrenia. However, despite similar neurocognitive deficits between patients with schizophrenia and bipolar disorder, few studies have extended neuroscience-based cognitive remediation programs to this population. METHODS/

designThe Treatment to Enhance Cognition in Bipolar Disorder study is an investigator-initiated, parallel group, randomized, blinded clinical trial of an Internet-based cognitive remediation protocol for patients with bipolar disorder I with psychosis (n = 100). We also describe the development of our dose-matched active control paradigm. Both conditions involve 70 sessions of computer-based activities over 24 weeks. The control intervention was developed to mirror the treatment condition in dose and format but without the neuroplasticity-based task design and structure. All participants undergo neuropsychological and clinical assessment at baseline, after approximately 25 hours of study activities, post treatment, and after 6 months of no study contact to assess durability. Neuroimaging at baseline and post treatment are offered in an "opt-in" format. The primary outcomes are scores on the MATRICS battery; secondary and exploratory outcomes include measures of clinical symptoms, community functioning, and neuroimaging changes. Associations between change in cognitive measures and change in community functioning will be assessed. Baseline predictors of treatment response will be examined. DISCUSSION: The present study is the first we are aware of to implement an Internet-based cognitive remediation program in patients with bipolar disorder with psychosis and to develop a comparable web-based control paradigm. The mixed online and study-site format allows accessible treatment while providing weekly staff contact and bridging. Based on user-provided feedback, participant blinding is feasible.

trial registrationClinicalTrials.gov NCT01470781 ; 11 July 2011.

Indexed as

CognitionAdolescentAdultBipolar DisorderBrainClinical ProtocolsCognitive RemediationFemaleHumansInternetMaleMassachusettsMiddle AgedNeuroimagingNeuronal PlasticityNeuropsychological TestsBipolar disorderCognitiveCognitive trainingControlRemediationTrial

Identifiers

PMID26969299
PMCPMC4788830

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.