NCT04590300

Brief Summary

People with schizophrenia and bipolar disorder display alterations in cognition and metacognition. These alterations may have an impact on learning during therapeutic education programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

October 6, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 18, 2024

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

September 10, 2020

Last Update Submit

June 17, 2024

Conditions

SchizophreniaBipolar Disorder

Outcome Measures

Primary Outcomes (2)

  • Evaluation of cognitive impairments on knowledge acquired through a therapeutic education program with Montreal Cognitive Assessment (MoCA)

    assess the impact of possible cognitive impairments on knowledge acquired through a therapeutic education program Minimum value = 0 \& Maximum value = 30 Score \< 26 is considered as abnormal

    1 year

  • Evaluation of metacognitive impairments on knowledge acquired through a therapeutic education program with Subjective Scale To Investigate Cognition in Schizophrenia (SSTICS)

    assess the impact of possible metacognitive impairments on knowledge acquired through a therapeutic education program Minimum value 21

    1 year

Secondary Outcomes (4)

  • assess the impact of self esteem acquired through a therapeutic education program with Rosenberg scale

    1 year

  • assess the impact of level of anxiety, acquired through a therapeutic education program with State-Trait-Anxiety Inventory (Forme Y) (STAI-Y) questionnaire

    1 year

  • assess the impact of depressive symptomatology acquired through a therapeutic education program with Center for Epidemiologic Studies-Depression (CES-D) scale

    1 year

  • assess the impact of literacy on knowledge acquired through a therapeutic education program with Rapid Estimate for Adult Literacy in Medicine (REALM-R) questionnaire

    1 year

Study Arms (2)

Schizophrenia

OTHER

1 questionnaire at the beginning of the study, before FTE program 1 questionnaire at the end of FTE

Other: QUESTIONNAIRES

Bipolar disorder

OTHER

1 questionnaire at the beginning of the study, before FTE program 1 questionnaire at the end of FTE

Other: QUESTIONNAIRES

Interventions

QUESTIONNAIRESOTHER

1 questionnaire at the beginning of the study, before FTE program 1 questionnaire at the end of FTE

Bipolar disorderSchizophrenia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consent to participate in the study,
  • Suffering from a chronic condition for which an therapeutic patient education (TEP) program is proposed.
  • Mastering the French language.
  • Be a beneficiary of health insurance

You may not qualify if:

  • Poor understanding of instructions that make it impossible to consent or assess
  • Neurodegenerative disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier CHARLES PERRENS

Bordeaux, Nouvelle-Aquitaine, 33076, France

Location

Related Publications (3)

  • Xia J, Merinder LB, Belgamwar MR. Psychoeducation for schizophrenia. Cochrane Database Syst Rev. 2011 Jun 15;2011(6):CD002831. doi: 10.1002/14651858.CD002831.pub2.

    PMID: 21678337BACKGROUND

  • Soo SA, Zhang ZW, Khong SJ, Low JEW, Thambyrajah VS, Alhabsyi SHBT, Chew QH, Sum MY, Sengupta S, Vieta E, McIntyre RS, Sim K. Randomized Controlled Trials of Psychoeducation Modalities in the Management of Bipolar Disorder: A Systematic Review. J Clin Psychiatry. 2018 May/Jun;79(3):17r11750. doi: 10.4088/JCP.17r11750.

    PMID: 29727072BACKGROUND

  • Flavell J.H. Metacognition and cognitive monitoring. A new area of cognitive-developmental inquiry. Am Psychol. 1979; 34(10):906-11

    BACKGROUND

MeSH Terms

Conditions

SchizophreniaBipolar Disorder

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Clelia QUILES, MD

    CH Charles Perrens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2020

First Posted

October 19, 2020

Study Start

October 6, 2020

Primary Completion

September 1, 2022

Study Completion

December 31, 2022

Last Updated

June 18, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)