- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03595670
Illness Representations in Patients With Bipolar Disorders (RsBiP)
July 11, 2018 updated by: Assistance Publique Hopitaux De Marseille
Illness Representations in Patients With Bipolar Disorders. What Mecanisms and What Impacts on Adherence and Quality of Life ?
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: raoul BELZEAUX, MD
- Phone Number: +33 491744082
- Email: raoul.belzeaux@ap-hm.fr
Study Locations
-
-
Paca
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Marseille, Paca, France, 13354
- Recruiting
- Assistance Publique des Hôpitaux de Marseille
-
Contact:
- RAOUL BELZEAUX, MD
- Phone Number: +33 4 91 74 40 82
- Email: RAOUL.belzeaux@ap-hm.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed bipolar in mania, depression or euthymic phases according DSM-IV critiera by psychiatrist
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
experimental group
• Patients diagnosed bipolar in mania, depression or euthymic phases according DSM-IV critiera by psychiatrist standardized questionnaires and interview will be performed |
standardized questionnaires concerning the perception
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Illness perception for schizophrenia (IPQS)
Time Frame: 24 hours
|
IPQS in an autoquestionnaire evaluating illness representations according to the self-regulation model.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Illness Perception Questionnaire Bref (IPQ-B)
Time Frame: 24 hours
|
IPQ-B evaluate similar dimensions from IPQ-S in only once item.
|
24 hours
|
Qualitative study of illness perceptions
Time Frame: 24 hours
|
Measure of illness representations according to the self-regulation model evaluated with a semi-structured interview.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 11, 2018
Primary Completion (ANTICIPATED)
April 1, 2020
Study Completion (ANTICIPATED)
October 1, 2020
Study Registration Dates
First Submitted
July 11, 2018
First Submitted That Met QC Criteria
July 11, 2018
First Posted (ACTUAL)
July 23, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 23, 2018
Last Update Submitted That Met QC Criteria
July 11, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-55
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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