Clinical Determinants of the Discrepancy Between Objective and Subjective Cognition in the Versailles FACE-BD Cohort

NCT04034147 | Completed DMC

• 1 other identifier: Versailles FACE-BD 002
• Study Type: observational
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

Metacognitive abilities have been scarcely investigated in bipolar disorders, with inconsistent results. This may appear somewhat surprising, as metacognitive training is a very promising intervention aiming at improving psychosocial functioning in bipolar disorders. One way to investigate metacognition is to address the discrepancy between objectively measured cognition (through neuropsychological testing) and subjective cognition (through self-reported questionnaire investigating one's perception of cognitive functioning). Objective and subjective cognition are two fundamental determinants of functioning in bipolar disorder. Objectively-measured cognition is directly associated with performance-based functional capacity but not with self-reported or interview-based functional capacity. In contrast, subjectively-measured cognition is associated with self-reported and interview-based functional capacity, but not performance-based functional capacity. Associations between subjective cognitive functioning and neuropsychological performances are usually weak, with a moderating effect of manic and depressive symptoms. Manic symptoms are associated with a decrease in cognitive complains, whereas depressive symptoms are associated with an increase in cognitive complaints. Predictors of the discrepancy between objective and subjective cognition in bipolar disorder are still weakly understood. One study reported that the subjective overestimation of cognitive dysfunctioning was positively predicted by more subsyndromal depressive and manic symptoms, hospitalizations, and BD type II. This study also reported that the subjective overestimation of cognitive dysfunctioning was associated with greater socio-occupational difficulties, more perceived stress, and lower quality of life. However, these previous studies had relatively limited sample sizes (below 150). They also ignored other potential predictors of the discrepancy between objective and subjective cognitions such as psychotic features, impulsiveness, and childhood trauma. Moreover, they also ignored whether this discrepancy was associated with medication adherence. The present study intends to explore the predictors of the discrepancy between objective and subjective cognition in bipolar disorder in a cross-sectional sample of 387 stable outpatients with bipolar disorders (type 1, type 2, not otherwise specified). The second objective is to determine whether the discrepancy between objective and subjective cognition in bipolar disorder predicts functioning, quality of life and medication adherence.

Conditions

Bipolar Disorder

Keywords

subjective cognition; metacognition; functioning; objective cognition; quality of life; medication adherence

Outcome Measures

Primary Outcomes (1)

• Discrepancy between objective and subjective cognition

  Sensitivity index scores (rank ordering for subjective performance minus rank ordering for objective performance; minimum -3; maximum 3; higher score indicates greater sensitivity, ie. that subjects reports more subjective complaints compared with their objective neuropsychological performance)

  one measure per subject, assessed one time at the inclusion

Secondary Outcomes (2)

• Subjective cognition in individuals without any objective cognitive deficit

  one measure per subject, assessed one time at the inclusion

• Subjective cognition in individuals with an objective cognitive deficit

  one measure per subject, assessed one time at the inclusion

Other Outcomes (5)

• Global Assessment of Functioning

  one measure per subject, assessed one time at the inclusion

• Psychosocial functioning in everyday life

  one measure per subject, assessed one time at the inclusion

• Medication adherence

  one measure per subject, assessed one time at the inclusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study included patients recruited into the FACE-BD (FondaMental Advanced Centers of Expertise for Bipolar Disorders) cohort at Versailles Hospital. This registry was set up by the Fondation FondaMental (www.fondation-fondamental. org) which created an infrastructure and provided resources to follow clinical cohorts and comparative-effectiveness research in patients with BD. Patients were referred by their general practitioner or by their psychiatrist.

You may qualify if:

• bipolar disorder according to DSM IV-R (structured clinical interview)

You may not qualify if:

• substance-related disorders in the previous month
• electroconvulsive therapy in the past year
• substantial neurological disorder

Sponsors & Collaborators

• Versailles Hospital: lead
• Fondation FondaMental: collaborator

Study Sites (1)

Paul ROUX

Le Chesnay, 78140, France

Location

Related Publications (7)

• Haffner P, Quinlivan E, Fiebig J, Sondergeld LM, Strasser ES, Adli M, Moritz S, Stamm TJ. Improving functional outcome in bipolar disorder: A pilot study on metacognitive training. Clin Psychol Psychother. 2018 Jan;25(1):50-58. doi: 10.1002/cpp.2124. Epub 2017 Aug 30.

  PMID: 28857347 BACKGROUND

• Lin X, Lu D, Huang Z, Chen W, Luo X, Zhu Y. The associations between subjective and objective cognitive functioning across manic or hypomanic, depressed, and euthymic states in Chinese bipolar patients. J Affect Disord. 2019 Apr 15;249:73-81. doi: 10.1016/j.jad.2019.02.025. Epub 2019 Feb 6.

  PMID: 30763798 BACKGROUND

• Miskowiak KW, Petersen JZ, Ott CV, Knorr U, Kessing LV, Gallagher P, Robinson L. Predictors of the discrepancy between objective and subjective cognition in bipolar disorder: a novel methodology. Acta Psychiatr Scand. 2016 Dec;134(6):511-521. doi: 10.1111/acps.12649. Epub 2016 Sep 20.

  PMID: 27644707 BACKGROUND

• Ott C, Mine H, Petersen JZ, Miskowiak K. Relation between functional and cognitive impairments in remitted patients with bipolar disorder and suggestions for trials targeting cognition: An exploratory study. J Affect Disord. 2019 Oct 1;257:382-389. doi: 10.1016/j.jad.2019.07.030. Epub 2019 Jul 5.

  PMID: 31302528 BACKGROUND

• Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.

  PMID: 12946886 BACKGROUND

• Van Camp L, Sabbe BGC, Oldenburg JFE. Metacognitive functioning in bipolar disorder versus controls and its correlations with neurocognitive functioning in a cross-sectional design. Compr Psychiatry. 2019 Jul;92:7-12. doi: 10.1016/j.comppsych.2019.06.001. Epub 2019 Jun 6.

  PMID: 31202082 BACKGROUND

• Yatham LN, Torres IJ, Malhi GS, Frangou S, Glahn DC, Bearden CE, Burdick KE, Martinez-Aran A, Dittmann S, Goldberg JF, Ozerdem A, Aydemir O, Chengappa KN. The International Society for Bipolar Disorders-Battery for Assessment of Neurocognition (ISBD-BANC). Bipolar Disord. 2010 Jun;12(4):351-63. doi: 10.1111/j.1399-5618.2010.00830.x.

  PMID: 20636632 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Medication Adherence

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Paul Roux

  Centre Hospitalier de Versailles, Service de psychiatrie de l'adulte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor of pqsychiatry

Study Record Dates

• First Submitted: July 20, 2019
• First Posted: July 26, 2019
• Study Start: January 1, 2009
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)