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

March 14, 2020 updated by: Dr Paul ROUX, Versailles Hospital

The Roots of Metacognitive Failures in Bipolar Disorders: Clinical Determinants of the Discrepancy Between Objective and Subjective Cognition in the Versailles FACE-BD Cohort

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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). All participants were included in the Versailles FACE-BD Cohort and were recruited via the Versailles FondaMental Center of expertise for Bipolar Disorders. BD was diagnosed based on the structured clinical interview that assesses DSM-IV-TR criteria.

Objective cognition was measured with a battery of cognitive tests. Experienced neuropsychologists administered the tests in a fixed order that was the same for every center. Testing lasted a total of 120 min, including 5 to 10-min breaks. The standardized test battery complied with the recommendations issued by the International Society for Bipolar Disorders. It included 11 tests and evaluated the following five cognitive domains:

  • processing speed, using the digit symbol coding and symbol search subtests from the Wechsler Adult Intelligence Scale (WAIS) version III, the Trail Making Test (TMT) part A, and the word and the color conditions of the Stroop test
  • attention, using the Conners' Continuous Performance Test II (omissions and commissions)
  • executive functions, using the colour/word condition of the Stroop test, the TMT part B and verbal fluency (semantic and phonemic conditions)
  • verbal memory, using the California Verbal Learning Test (CVLT) immediate recall, short and long delay free recall, and total recognition
  • working memory, using the WAIS-III digit span (sum of forward and backward conditions) and the spatial span (forward and backward conditions) subtest from the Wechsler Memory Scale version III

Subjective cognition was measured with item 10 of the Quick Inventory of Depressive Symptomatology-Self-Report-16.

This item focuses over the past 7 days and investigates "Concentration/decision-making:

  • 0 There was no change in my usual ability to concentrate or make decisions.
  • 1 I occasionally felt indecisive or found that my attention wandered.
  • 2 Most of the time, I found it hard to focus or to make decisions.
  • 3 I couldn't concentrate well enough to read or I couldn't make even minor decisions"

Predictors of the discrepancy between objective and subjective cognition were:

  • type of bipolar disorder
  • psychotic features
  • age at onset; number of previous mixed, hypomanic, manic, and major depressive episodes; total duration of hospitalizations
  • severity of the bipolar disorder with the Clinical Global Impression-Severity
  • lithium carbonate, anticonvulsants, antipsychotics, antidepressants, or anxiolytics at the time of testing
  • hetero-evaluation of depression with the Montgomery Åsberg Depression Rating Scale
  • hetero-evaluation of mania with the Young Mania Rating Scale
  • auto-evaluation of the state of anxiety with the state subscale of the State-Trait Anxiety Inventory, form Y-A
  • impulsiveness with the Barratt Impulsiveness Scale
  • childhood trauma with the Childhood Trauma Questionnaire

The variable predicted by the discrepancy between objective and subjective cognition were:

  • the global functioning with the Global Assessment of Functioning scale
  • psychosocial functioning in everyday life was assessed with the Functioning Assessment Short Test
  • medication adherence with the MEDICATION ADHERENCE RATING SCALE
  • quality of life with the EQ-5D

Study Type

Observational

Enrollment (Actual)

387

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Chesnay, France, 78140
        • Paul ROUX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discrepancy between objective and subjective cognition
Time Frame: one measure per subject, assessed one time at the inclusion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective cognition in individuals without any objective cognitive deficit
Time Frame: one measure per subject, assessed one time at the inclusion
Subjective cognition measured with item 10 of the Quick Inventory of Depressive Symptomatology-Self-Report-16, minium 0; maximum 3; higher scores indicates worse subjective cognition)
one measure per subject, assessed one time at the inclusion
Subjective cognition in individuals with an objective cognitive deficit
Time Frame: one measure per subject, assessed one time at the inclusion
Subjective cognition measured with item 10 of the Quick Inventory of Depressive Symptomatology-Self-Report-16, minium 0; maximum 3; higher scores indicates worse subjective cognition)
one measure per subject, assessed one time at the inclusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Assessment of Functioning
Time Frame: one measure per subject, assessed one time at the inclusion
the score on the Global Assessment of Functioning scale (minimum 1; maximum 100; higher scores indicates better functioning)
one measure per subject, assessed one time at the inclusion
Psychosocial functioning in everyday life
Time Frame: one measure per subject, assessed one time at the inclusion
total score on the Functioning Assessment Short Test (lower bound 0 upper bound 72, lower scores indicates better functioning)
one measure per subject, assessed one time at the inclusion
Medication adherence
Time Frame: one measure per subject, assessed one time at the inclusion
Total score on the Medication Adherence Rating Scale (minium 0; maximum 10; lower scores indicates worse adherence)
one measure per subject, assessed one time at the inclusion
Quality of Life (domains): EQ-5D-5L
Time Frame: one measure per subject, assessed one time at the inclusion
Index Value on the EQ-5D-5L (minimum -0.53; maximum 1; higher score indicates better Quality of Life)
one measure per subject, assessed one time at the inclusion
Quality of Life (general): visual analogic scale
Time Frame: one measure per subject, assessed one time at the inclusion
score on the visual analogic scale (minimum 0; maximum 100; higher score indicates better Quality of Life)
one measure per subject, assessed one time at the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Collaborators

Fondation FondaMental

Investigators

  • Principal Investigator: Paul Roux, Centre Hospitalier de Versailles, Service de psychiatrie de l'adulte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

July 20, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (ACTUAL)

July 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 14, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Versailles FACE-BD 002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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