Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT02855762 - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder N/A
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Completed NCT02513654 - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects Phase 1
Recruiting NCT06313918 - Exercise Therapy in Mental Disorders-study N/A
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1
Recruiting NCT06197048 - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT02212041 - Electronic Cigarettes in Smokers With Mental Illness N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Not yet recruiting NCT04432116 - Time and Virtual Reality in Schizophrenia and Bipolar Disorder N/A
Terminated NCT02909504 - Gao NARASD Lithium Study Phase 4
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Terminated NCT02893371 - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
Recruiting NCT02481245 - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study Phase 2