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Early Maladaptative Schemas Among Euthymic Patients With Bipolar Disorder in the Versailles FondaMental Advanced Centers of Expertise for Bipolar Disorders Cohort

Early Maladaptative Schemas Among Euthymic Patients With Bipolar Disorder: Exploring the Relationships With Symptoms, Functioning and Cognition in the Versailles FondaMental Advanced Centers of Expertise for Bipolar Disorders

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03977909
Acronym
SPIBIP
Enrollment
150
Registered
2019-06-06
Start date
2009-07-01
Completion date
2024-12-01
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Early Maladaptative Schemas, Cognition, Functioning

Brief summary

Early Maladaptive Schemas (EMS) are overactivated in euthymic bipolar disorders (BD) and are associated with poor psychosocial functioning and higher suicidality. The first objective of this study is to establish different clusters of EMS in euthymic bipolar disorders, compare these clusters according to the clinical characteristics of BD and neuropsychological performances and evaluate the temporal stability of these clusters at 12 and 24 months. The second objective of this study is to quantify the impact of EMS on functioning in euthymic BD, beyond the effect of cognition and residual depressive symptoms.

Detailed description

Early Maladaptive Schemas (EMS) are overactivated in euthymic bipolar disorders (BD) and are associated with poor psychosocial functioning and higher suicidality. However, few studies have explored EMS in bipolar disorders, despite EMS therapy is a promising tool for the psychotherapy of BD. This study will use the data collected at the Versailles Expert Center for Bipolar disorder, in the local FACE-BD registry. These data will be collected at the inclusion, 12 months and 24 months later. They included an extensive neuropsychological battery and an extensive evaluation of the clinical characteristics of bipolar disorder. EMS will be measured with the Young Schema Questionnaire Short Form 3. The first objective of this study is to establish different clusters of EMS in euthymic bipolar disorders, compare these clusters according to the clinical characteristics of BD and neuropsychological performances and evaluate the temporal stability of these clusters at 12 and 24 months. The second objective of this study is to quantify the impact of EMS on functioning in euthymic BD, beyond the effect of cognition and residual depressive symptoms.

Interventions

None listed

Sponsors

Fondation FondaMental
CollaboratorOTHER
Versailles Saint-Quentin-en-Yvelines University
CollaboratorOTHER
University of Bordeaux
CollaboratorOTHER
Versailles Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* major depressive or manic or hypomanic during the evaluation * Montgomery Åsberg Depression Rating Scale ⩽10 * Young Mania Rating Scale ⩽12

Design outcomes

Primary

MeasureTime frameDescription
Early Maladaptative Schemas T018 measures by subject, assessed at inclusiondistance to the norm for the scores on each 18 early maladaptative schema measured with the Young Shema Questionnaire short form 3, no lower bound limit, no upper bound limit, a low score indicate a lower activation of the Early Maladaptative Schema
Early Maladaptative Schemas T1218 measures by subject, assessed at 12 monthsdistance to the norm for the scores on each 18 early maladaptative schema measured with the Young Shema Questionnaire short form 3, no lower bound limit, no upper bound limit, a low score indicate a lower activation of the Early Maladaptative Schema
Early Maladaptative Schemas T2418 measures by subject, assessed at inclusion 24 monthsdistance to the norm for the scores on each 18 early maladaptative schema measured with the Young Shema Questionnaire short form 3, no lower bound limit, no upper bound limit, a low score indicate a lower activation of the Early Maladaptative Schema

Secondary

MeasureTime frameDescription
functioningone measure by subject, assessed 3 times (inclusion, 12 months and 24 months)total score on the Functioning Assessment Short Test (lower bound 0 upper bound 72, lower scores indicates better functioning)
Hypomaniaone measure by subject, assessed 3 times (inclusion, 12 months and 24 months)total score on the Young Mania Rating Scale (lower bound 0 upper bound 12, lower scores indicate lower hypomania
Depressionone measure by subject, assessed 3 times (inclusion, 12 months and 24 months)total score on the Montgomery Åsberg Depression Rating Scale (minimum 0 maximum 10)
Cognition5 measures by subject, assessed 2 times (at inclusion and 24 months)distance to the norm for the scores for each the five cognitive dimension measured with the standardised neuropsychological battery, no lower bound limit, no upper bound limit, lower scores indicate poorer cognition

Countries

France

Contacts

Primary ContactPaul ROUX, MD PhD
paul.roux@uvsq.fr+33139638310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026