Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder (ShareD-BD)

Centre Hospitalier Universitaire de Nīmes

Status: Active, not recruiting

Conditions: Bipolar Disorder

Treatments: Other: standard care; Other: Shared-decision making process

Study type: Interventional

Funder types: Other

Identifiers

NCT03245593

PREPS/2016/LS-01

Details and patient eligibility

About

The investigators hypothesize that implementation of a shared decision making care plan for prophylactic treatment will help therapeutic adherence of bipolar patients. They also anticipate that patients treated according to a shared decision making plan will have an elevated satisfaction of their care, quality of life and functionment, as well as a lower number of relapses

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• The patient must be available for the 12 months of follow-up
• The patient is at least 18 years old
• Patients is suffering from bipolar disorder (I or II) according to DSM-5 criteria
• Following resolution of a mood episode (manic or depressive according to DSM-5 criteria) according to the criteria of l'International Society for Bipolar Disorder (Recovery, clinical remission of at least 4 weeks)
• Followed by at least one of the practitioner belonging to one of the participating centers
• Without comprehension problems of fluent French

Exclusion criteria

• The subject is participating in an interventional study, or has participated in another interventional study within the previous 3 months
• The subject is in a period of exclusion determined by a previous study
• The patient is under safeguard of justice or state guardianship
• It is impossible to give the subject informed information, or the subject refuses to sign the consent
• The subject has already participated in this study
• The patient has troubles linked to the usage of severe intensive substances (such as those defined by the DMS-5)
• The patient has a revision of the initial diagnosis of bipolar disorder

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Shared Decision making for care

Experimental group

Treatment:

Other: Shared-decision making process

Standard decision making for care

Other group

Treatment:

Other: standard care