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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Bipolar Disorder
• Intervention / Treatment: Other: Shared-decision making process; Other: standard care

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CH Charles Perrens
  • Bron, France, 69678
    • CH Le Vinatier
  • Béziers, France, 34500
    • Ch Beziers
  • Clermont-Ferrand, France, 63003
    • CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
  • Clermont-Ferrand, France, 63037
    • CH Sainte-Marie de Clermont-Ferrand
  • Clermont-Ferrand, France, 63003
    • Chu Gabriel Montpied Clermont Ferrand
  • Créteil, France, 94010
    • APHP - Centre Hospitalier Henri Mondor
  • Grenoble, France, 38043
    • CHU de Grenoble - Hopital Albert Michallon
  • Limoges, France, 87025
    • CH Limoges
  • Marseille, France, 13274
    • APHM - Hôpital Sainte-Marguerite
  • Montpellier, France, 34295
    • CHU de Montpellier - Hôpital Lapeyronie
  • Nancy, France, 54000
    • CHU Nancy
  • Nantes, France, 44000
    • CHU Nantes
  • Nîmes, France, 30029
    • CHU Nîmes
  • Nîmes, France, 30000
    • Clinique des troubles thymiques
  • Paris, France, 75475
    • APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Patients with biopolar disorder in consultation at one of the recruiting centers

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shared Decision making for care	Other: Shared-decision making process; Completion of the Ottawa Personal Decision Guide to help guide care with the support of online and printed material describing the therapeutic options available
Other: Standard decision making for care	Other: standard care; Care of patients according to standard practice of managing patients with bipolar disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the difference of prophylactic treatment compliance between bipolar patients receiving treatment according to standard care versus a shared decision making care plan following a mood episode.	Clinician Rating Scale (1-7)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study the clinician-reported difference between the 2 groups in medication adherence	Clinician Rating Scale (1-7)	3 months
Study the clinician-reported difference between the 2 groups in medication adherence	Clinician Rating Scale (1-7)	6 months
Study the clinician-reported difference between the 2 groups in medication adherence	Clinician Rating Scale (1-7)	9 months
Study the self-reported difference between the 2 groups in medication adherence	Medication Adherence Rating Scale( 0-10),	3 months
Study the self-reported difference between the 2 groups in medication adherence	Medication Adherence Rating Scale( 0-10),	6 months
Study the self-reported difference between the 2 groups in medication adherence	Medication Adherence Rating Scale( 0-10),	9 months
Study the self-reported difference between the 2 groups in medication adherence	Medication Adherence Rating Scale( 0-10),	12 months
Clinical evaluation of the difference between the 2 groups in medication adherence	Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants	3 months
Clinical evaluation of the difference between the 2 groups in medication adherence	Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants	6 months
Clinical evaluation of the difference between the 2 groups in medication adherence	Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants	9 months
Clinical evaluation of the difference between the 2 groups in medication adherence	Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants	12 months
Compare difference in the adherence to personalized follow-up between groups	percentage of consultations missed	3 months
Compare difference in the adherence to personalized follow-up between groups	percentage of consultations missed	6 months
Compare difference in the adherence to personalized follow-up between groups	percentage of consultations missed	9 months
Compare difference in the adherence to personalized follow-up between groups	percentage of consultations missed	12 months
Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale (0-100)	3 months
Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale (0-100)	6 months
Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale (0-100)	9 months
Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale (0-100)	12 months
Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45: 3 questions scored 1-5	3 months
Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45: 3 questions scored 1-5	6 months
Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45: 3 questions scored 1-5	9 months
Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45: 3 questions scored 1-5	12 months
Compare difference in patient satisfaction concerning the decision-making process between groups	Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5	3 months
Compare difference in patient satisfaction concerning the decision-making process between groups	Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5	6 months
Compare difference in patient satisfaction concerning the decision-making process between groups	Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5	9 months
Compare difference in patient satisfaction concerning the decision-making process between groups	Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5	12 months
Compare difference in therapeutic alliance between groups	4-Point ordinal Alliance Scale	3 months
Compare difference in therapeutic alliance between groups	4-Point ordinal Alliance Scale	6 months
Compare difference in therapeutic alliance between groups	4-Point ordinal Alliance Scale	9 months
Compare difference in therapeutic alliance between groups	4-Point ordinal Alliance Scale	12 months
Compare difference in knowledge of disease and treatment necessary to making decisions between groups	Knowledge questionnaire: % correct answers	3 months
Compare difference in knowledge of disease and treatment necessary to making decisions between groups	Knowledge questionnaire: % correct answers	6 months
Compare difference in knowledge of disease and treatment necessary to making decisions between groups	Knowledge questionnaire: % correct answers	9 months
Compare difference in knowledge of disease and treatment necessary to making decisions between groups	Knowledge questionnaire: % correct answers	12 months
Compare difference in patient attitude towards the treatment between groups	Beliefs about Medicines Questionnaire: 18 questions 1-5	3 months
Compare difference in patient attitude towards the treatment between groups	Beliefs about Medicines Questionnaire: 18 questions 1-5	6 months
Compare difference in patient attitude towards the treatment between groups	Beliefs about Medicines Questionnaire: 18 questions 1-5	9 months
Compare difference in patient attitude towards the treatment between groups	Beliefs about Medicines Questionnaire: 18 questions 1-5	12 months
Compare number and duration of mood episodes between groups months	number of events; number of days	3 months
Compare number and duration of mood episodes between groups months	number of events; number of days	6 months
Compare number and duration of mood episodes between groups months	number of events; number of days	9 months
Compare number and duration of mood episodes between groups months	number of events; number of days	12 months
Compare number and duration of hospitalizations in psychiatric service between groups	number of events; number of days	3 months
Compare number and duration of hospitalizations in psychiatric service between groups	number of events; number of days	6 months
Compare number and duration of hospitalizations in psychiatric service between groups	number of events; number of days	9 months
Compare number and duration of hospitalizations in psychiatric service between groups	number of events; number of days	12 months
Compare manic symptomatology during evaluations between groups	Young Mania Rating Scale	3 months
Compare manic symptomatology during evaluations between groups	Young Mania Rating Scale	6 months
Compare manic symptomatology during evaluations between groups	Young Mania Rating Scale	9 months
Compare manic symptomatology during evaluations between groups	Young Mania Rating Scale	12 months
Compare the depressive symptomatology during evaluations between groups	Montgomery-Asberg Depression Rating Scale	3 months
Compare the depressive symptomatology during evaluations between groups	Montgomery-Asberg Depression Rating Scale	6 months
Compare the depressive symptomatology during evaluations between groups	Montgomery-Asberg Depression Rating Scale	9 months
Compare the depressive symptomatology during evaluations between groups	Montgomery-Asberg Depression Rating Scale	12 months
Compare severity and intensity of suicidal ideas between groups	Columbia-Suicide Severity Rating Scale	3 months
Compare severity and intensity of suicidal ideas between groups	Columbia-Suicide Severity Rating Scale	6 months
Compare severity and intensity of suicidal ideas between groups	Columbia-Suicide Severity Rating Scale	9 months
Compare severity and intensity of suicidal ideas between groups	Columbia-Suicide Severity Rating Scale	12 months
Compare the psychosocial functioning between groups	Functioning Assessment Short Test (0-72)	3 months
Compare the psychosocial functioning between groups	Functioning Assessment Short Test (0-72)	6 months
Compare the psychosocial functioning between groups	Functioning Assessment Short Test (0-72)	9 months
Compare the psychosocial functioning between groups	Functioning Assessment Short Test (0-72)	12 months
Compare quality of life between groups	WHOQOL-BREF (0-100)	3 months
Compare quality of life between groups	WHOQOL-BREF (0-100)	6 months
Compare quality of life between groups	WHOQOL-BREF (0-100)	9 months
Compare quality of life between groups	WHOQOL-BREF (0-100)	12 months
Compare length of consultations between groups	minutes	every consultation for 12 months
Clinician satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45 doctor version 3 questions scored 1-5	3 months
Clinician satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45 doctor version 3 questions scored 1-5	6 months
Clinician satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45 doctor version 3 questions scored 1-5	9 months
Clinician satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45 doctor version 3 questions scored 1-5	12 months
Clinician satisfaction concerning the decision-making process between groups	Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5	3 months
Clinician satisfaction concerning the decision-making process between groups	Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5	6 months
Clinician satisfaction concerning the decision-making process between groups	Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5	9 months
Clinician satisfaction concerning the decision-making process between groups	Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5	12 months
Clinician perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale doctor version (0-100)	3 months
Clinician perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale doctor version (0-100)	6 months
Clinician perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale doctor version (0-100)	9 months
Clinician perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale doctor version (0-100)	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Ludovic SAMALIN, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• Samalin L, Honciuc M, Boyer L, de Chazeron I, Blanc O, Abbar M, Llorca PM. Efficacy of shared decision-making on treatment adherence of patients with bipolar disorder: a cluster randomized trial (ShareD-BD). BMC Psychiatry. 2018 Apr 13;18(1):103. doi: 10.1186/s12888-018-1686-y.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Bipolar Disorder; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: PREPS/2016/LS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No