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

NCT03977909 | Unknown DMC

• 1 other identifier: CHVersailles
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Early Maladaptative Schemas; Cognition; Functioning

Outcome Measures

Primary Outcomes (3)

• Early Maladaptative Schemas T0

  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

  18 measures by subject, assessed at inclusion

• Early Maladaptative Schemas T12

  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

  18 measures by subject, assessed at 12 months

• Early Maladaptative Schemas T24

  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

  18 measures by subject, assessed at inclusion 24 months

Secondary Outcomes (4)

• functioning

  one measure by subject, assessed 3 times (inclusion, 12 months and 24 months)

• Depression

  one measure by subject, assessed 3 times (inclusion, 12 months and 24 months)

• Cognition

  5 measures by subject, assessed 2 times (at inclusion and 24 months)

• Hypomania

  one measure by subject, assessed 3 times (inclusion, 12 months and 24 months)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Versailles Hospital: lead
• Fondation FondaMental: collaborator
• Versailles Saint-Quentin-en-Yvelines University: collaborator
• University of Bordeaux: collaborator

Study Sites (1)

Paul ROUX

Le Chesnay, 78140, France

RECRUITING

Related Publications (8)

• Ball J, Mitchell P, Malhi G, Skillecorn A, Smith M. Schema-focused cognitive therapy for bipolar disorder: reducing vulnerability to relapse through attitudinal change. Aust N Z J Psychiatry. 2003 Feb;37(1):41-8. doi: 10.1046/j.1440-1614.2003.01098.x.

  PMID: 12534655 BACKGROUND

• Hawke LD, Provencher MD, Parikh SV. Schema therapy for bipolar disorder: a conceptual model and future directions. J Affect Disord. 2013 May 15;148(1):118-22. doi: 10.1016/j.jad.2012.10.034. Epub 2012 Dec 4.

  PMID: 23218898 BACKGROUND

• Morriss R. Clinical importance of inter-episode symptoms in patients with bipolar affective disorder. J Affect Disord. 2002 Dec;72 Suppl 1:S3-13. doi: 10.1016/s0165-0327(02)00340-3.

  PMID: 12589898 BACKGROUND

• Nilsson KK. Early maladaptive schemas and functional impairment in remitted bipolar disorder patients. J Behav Ther Exp Psychiatry. 2012 Dec;43(4):1104-8. doi: 10.1016/j.jbtep.2012.05.005. Epub 2012 Jun 7.

  PMID: 22743343 BACKGROUND

• Roux P, Raust A, Cannavo AS, Aubin V, Aouizerate B, Azorin JM, Bellivier F, Belzeaux R, Bougerol T, Cussac I, Courtet P, Etain B, Gard S, Job S, Kahn JP, Leboyer M, Olie E; FondaMental Advanced Centers of Expertise in Bipolar Disorders (FACE-BD) Collaborators; Henry C, Passerieux C. Associations between residual depressive symptoms, cognition, and functioning in patients with euthymic bipolar disorder: results from the FACE-BD cohort. Br J Psychiatry. 2017 Dec;211(6):381-387. doi: 10.1192/bjp.bp.117.201335. Epub 2017 Oct 19.

  PMID: 29051175 BACKGROUND

• Urosevic S, Abramson LY, Harmon-Jones E, Alloy LB. Dysregulation of the behavioral approach system (BAS) in bipolar spectrum disorders: review of theory and evidence. Clin Psychol Rev. 2008 Oct;28(7):1188-205. doi: 10.1016/j.cpr.2008.04.004. Epub 2008 May 9.

  PMID: 18565633 BACKGROUND

• Young, J. E., & Brown, G. (1998). Young schema questionnaire short form. New York: Cognitive Therapy Center.

  BACKGROUND

• Young, J. E., Klosko, J. S., & Weishaar, M. E. (2003). Schema therapy: A practitioner's guide, Guilford Press.

  BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Paul ROUX, MD PhD

CONTACT

+33139638310; paul.roux@uvsq.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatre, Maître de Conférence des Université Praticien Hospitalier

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: July 1, 2009
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)