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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03595670
Other study ID # 2017-55
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 11, 2018
Est. completion date October 2020

Study information

Verified date July 2018
Source Assistance Publique Hopitaux De Marseille
Contact raoul BELZEAUX, MD
Phone +33 491744082
Email raoul.belzeaux@ap-hm.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

Bipolar disorder is a serious and chronic illness representing a major health problem with high mortality rates (Colom and Lam, 2005). According to the self-regulation model (Leventhal, Nerenz & Steel, 1986), 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 (Lobban et al., 2013) and to medication adherence (Averous, Charbonnier, Lagouanelle-Simeoni, Prosperi & Dany, 2018). 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
standardized questionnaires
standardized questionnaires concerning the perception
interview
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.

Locations

Country Name City State
France Assistance Publique Des Hopitaux de Marseille Marseille Paca

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Illness perception for schizophrenia (IPQS) IPQS in an autoquestionnaire evaluating illness representations according to the self-regulation model. 24 hours
Secondary Illness Perception Questionnaire Bref (IPQ-B) IPQ-B evaluate similar dimensions from IPQ-S in only once item. 24 hours
Secondary Qualitative study of illness perceptions Measure of illness representations according to the self-regulation model evaluated with a semi-structured interview. 24 hours
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