NCT03595670

Brief Summary

Bipolar disorder is a serious and chronic illness representing a major health problem with high mortality rates. According to the self-regulation model , patients had some representations of their illness which are cognitive and emotional. Cognitive representations include the set of beliefs built around the illness, its consequences and treatment. Emotional representations are negative emotions generated by the presence of the illness. According to Leventhal et al. (1997), representations are linked to information extracts by patients from society, relatives, experiences. This model has been particularly studied in the context of somatic disorders, but Baines \& Wittkowski (2013) shown that it may also be relevant in patients with mental disorders. In bipolar disorders, first results show that illness representations are related to relapses and to medication adherence. That's why, we think that this relevant to improve knowledges of the psychological processes that accompany the experience of bipolar disorders. To assess illness representation, we will use both qualitative and quantitative tools. These results could have direct application to clinical practice in psychosocial interventions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 11, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

July 11, 2018

Last Update Submit

July 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Illness perception for schizophrenia (IPQS)

    IPQS in an autoquestionnaire evaluating illness representations according to the self-regulation model.

    24 hours

Secondary Outcomes (2)

  • Illness Perception Questionnaire Bref (IPQ-B)

    24 hours

  • Qualitative study of illness perceptions

    24 hours

Study Arms (1)

experimental group

• Patients diagnosed bipolar in mania, depression or euthymic phases according DSM-IV critiera by psychiatrist standardized questionnaires and interview will be performed

Other: standardized questionnairesOther: interview

Interventions

standardized questionnaires concerning the perception

experimental group

Semi-directive interviews will be conducted. The purpose of this approach is to question the meaning of the disease (beliefs, representations), the psycho-social management of the disease, its inscription in the socio-cultural condition of the patients.

experimental group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed bipolar in mania, depression or euthymic phases according DSM-IV critiera by psychiatrist

You may qualify if:

  • Men or women whose is between 18 and 85 years
  • Patients diagnosed bipolar in mania, depression or euthymic phases according DSM-IV critiera by psychiatrist
  • Taking in charge in the framework of service Psychiatrie Secteur 5 - Hôpitaux Sud - Hôpital Sainte Marguerite de Marseille
  • Patients agreeing to participate to study

You may not qualify if:

  • Minor patients or over 85 years old
  • Patients not understanding French
  • Patients with neurological or psychiatric disorders prohibiting their comprehension of the study
  • Patients deprived of their liberty following a judicial or administrative decision
  • Patients supported without their consent
  • Patients under legal guardianship
  • Patients treated in emergencies
  • Patients refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental 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

  • EMILIE GARRIDO PRADALIE

    APHM

    STUDY DIRECTOR

Central Study Contacts

raoul BELZEAUX, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 23, 2018

Study Start

April 11, 2018

Primary Completion

April 1, 2020

Study Completion

October 1, 2020

Last Updated

July 23, 2018

Record last verified: 2018-07

Locations