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

Sponsor

Versailles Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04034147

Collaborator

Fondation FondaMental (Other)

387

Enrollment

Location

120

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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 second objective is to determine whether the discrepancy between objective and subjective cognition in bipolar disorder predicts functioning, quality of life and medication adherence.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

387 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Outcome Measures

Primary Outcome Measures

Discrepancy between objective and subjective cognition [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)

Secondary Outcome Measures

Subjective cognition in individuals without any objective cognitive deficit [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)
Subjective cognition in individuals with an objective cognitive deficit [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)

Other Outcome Measures

Global Assessment of Functioning [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)
Psychosocial functioning in everyday life [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)
Medication adherence [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)
Quality of Life (domains): EQ-5D-5L [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)
Quality of Life (general): visual analogic scale [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Paul ROUX	Le Chesnay		France	78140

Sponsors and Collaborators

Versailles Hospital
Fondation FondaMental

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Dr Paul ROUX, Associated Professor of pqsychiatry, Versailles Hospital

ClinicalTrials.gov Identifier:

NCT04034147

Other Study ID Numbers:

Versailles FACE-BD 002

First Posted:

Jul 26, 2019

Last Update Posted:

Mar 17, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr Paul ROUX, Associated Professor of pqsychiatry, Versailles Hospital

Additional relevant MeSH terms:

Bipolar Disorder

Study Results

No Results Posted as of Mar 17, 2020