Clinical trial NCT04034147: Clinical Determinants of the Discrepancy Between Objective and Subjective Cognition in the Versailles FACE-BD Cohort
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: subjective cognition
metacognition
functioning
objective cognition
quality of life
medication adherence
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
Collaborators: name: Fondation FondaMental
First posted: 2019-07-26
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Discrepancy between objective and subjective cognition
timeFrame: one measure per subject, assessed one time at the inclusion
Secondary outcomes:
measure: Subjective cognition in individuals without any objective cognitive deficit
timeFrame: one measure per subject, assessed one time at the inclusion
measure: Subjective cognition in individuals with an objective cognitive deficit
timeFrame: one measure per subject, assessed one time at the inclusion
Other outcomes:
measure: Global Assessment of Functioning
timeFrame: one measure per subject, assessed one time at the inclusion
measure: Psychosocial functioning in everyday life
timeFrame: one measure per subject, assessed one time at the inclusion
measure: Medication adherence
timeFrame: one measure per subject, assessed one time at the inclusion
measure: Quality of Life (domains): EQ-5D-5L
timeFrame: one measure per subject, assessed one time at the inclusion
measure: Quality of Life (general): visual analogic scale
timeFrame: one measure per subject, assessed one time at the inclusion
Locations:
city: Le Chesnay
country: France
facility: Paul ROUX
Study officials:
affiliation: Centre Hospitalier de Versailles, Service de psychiatrie de l'adulte
name: Paul Roux
role: PRINCIPAL_INVESTIGATOR
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