Bipolar DisorderRsBiPNCT03595670
Illness Representations in Patients With Bipolar Disorders
An observational study of Bipolar Disorder, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- standardized questionnaires and interview
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2018to Oct 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed bipolar in mania, depression or euthymic phases according DSM-IV critiera by psychiatrist
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
RAOUL BELZEAUX, MD, +33 4 91 74 40 82, RAOUL.belzeaux@ap-hm.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- standardized questionnaires, interview
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized questionnairesOther
standardized questionnaires concerning the perception
interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | • Patients diagnosed bipolar in mania, depression or euthymic phases according DSM-IV critiera by psychiatrist
standardized questionnaires and interview will be performed Receives: Other: standardized questionnaires; Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illness perception for schizophrenia (IPQS)
IPQS in an autoquestionnaire evaluating illness representations according to the self-regulation model.
Measured: 24 hours
Secondary outcomes (2)
Illness Perception Questionnaire Bref (IPQ-B)
IPQ-B evaluate similar dimensions from IPQ-S in only once item.
Measured: 24 hours
Qualitative study of illness perceptions
Measure of illness representations according to the self-regulation model evaluated with a semi-structured interview.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start11 Apr 2018
- Primary completionApr 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595670
- Sponsor's protocol ID
- 2017-55
- Acronym
- RsBiP
- Status last verified
- Jul 2018
- First submitted
- 11 Jul 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Illness Representations in Patients With Bipolar Disorders. What Mecanisms and What Impacts on Adherence and Quality of Life ?
- ClinicalTrials.gov ID
- NCT03595670
- Acronym / sponsor ID
- RsBiP / 2017-55
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Other: standardized questionnaires, Other: interview• Patients diagnosed bipolar in mania, depression or euthymic phases according DSM-IV critiera by psychiatrist standardized questionnaires and interview will be performed |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed bipolar in mania, depression or euthymic phases according DSM-IV critiera by psychiatrist
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardized questionnairesstandardized questionnaires concerning the perception | Other | experimental group |
| interviewSemi-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. | Other | experimental group |
Primary outcome
Illness perception for schizophrenia (IPQS)
Time frame: 24 hours
IPQS in an autoquestionnaire evaluating illness representations according to the self-regulation model.
2 secondary outcomes
Illness Perception Questionnaire Bref (IPQ-B)
Time frame: 24 hours
Qualitative study of illness perceptions
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact raoul BELZEAUX, MD (+33 491744082, raoul.belzeaux@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illness perception for schizophrenia (IPQS) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.