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Bipolar DisorderSPIBIPNCT03977909

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

An observational study of Bipolar Disorder, run by Versailles Hospital at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Disorder
How many people
150 participants
Where
1 siteFrance
Study dates
1 Jul 2009to 1 Dec 2024
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Paul ROUX, MD PhD contact

+33139638310

paul.roux@uvsq.fr

France1 site, 1 recruiting

  • Paul ROUX

    Le Chesnay, 78140

    Paul ROUX, MD PhD, paul.roux@uvsq.fr

    Recruiting

Other trials in France

About this study

Official title: 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

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.

Read the 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.

Keywords
Early Maladaptative Schemas, Cognition, Functioning
Medical subject headings
Bipolar Disorder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 18 measures by subject, assessed at inclusion

  2. 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

    Measured: 18 measures by subject, assessed at 12 months

  3. 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

    Measured: 18 measures by subject, assessed at inclusion 24 months

Secondary outcomes (4)

  1. functioning

    total score on the Functioning Assessment Short Test (lower bound 0 upper bound 72, lower scores indicates better functioning)

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

  2. Depression

    total score on the Montgomery Åsberg Depression Rating Scale (minimum 0 maximum 10)

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

  3. Cognition

    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

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

  4. Hypomania

    total score on the Young Mania Rating Scale (lower bound 0 upper bound 12, lower scores indicate lower hypomania

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2019
  2. Study start1 Jul 2009
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03977909
Sponsor's protocol ID
CHVersailles
Acronym
SPIBIP
Status last verified
Aug 2023
First submitted
5 Jun 2019
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12534655

  • 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.

    PubMed 23218898

  • 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.

    PubMed 12589898

  • 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.

    PubMed 22743343

  • 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.

    PubMed 29051175

  • 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.

    PubMed 18565633

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

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

Questions about this trial

What is this clinical trial studying?

An observational study of Bipolar Disorder, run by Versailles Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paul ROUX, MD PhD (+33139638310, paul.roux@uvsq.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early Maladaptative Schemas T0 (time frame: 18 measures by subject, assessed at inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03977909, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.

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