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

Recruiting

• Conditions: Bipolar Disorder

• Registration Number: NCT03977909
• Lead Sponsor: Versailles Hospital

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.

Study Timeline

• Study Start: 2009-07-01
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early Maladaptative Schemas T12	18 measures by subject, assessed at 12 months	distance 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 T24	18 measures by subject, assessed at inclusion 24 months	distance 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 T0	18 measures by subject, assessed at inclusion	distance 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 Outcome Measures

Name	Time	Method
Cognition	5 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
Hypomania	one 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
Depression	one 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)
functioning	one 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)

Trial Locations

Locations (1)

Paul ROUX; 🇫🇷 Le Chesnay, France