Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

NCT03245593 | Active Not Recruiting

• 1 other identifier: PREPS/2016/LS-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (80)

• Study the clinician-reported difference between the 2 groups in medication adherence

  3 months

• Study the clinician-reported difference between the 2 groups in medication adherence

  6 months

• Study the clinician-reported difference between the 2 groups in medication adherence

  9 months

• Study the self-reported difference between the 2 groups in medication adherence

  3 months

• Study the self-reported difference between the 2 groups in medication adherence

  6 months

Study Arms (2)

Shared Decision making for care

EXPERIMENTAL

Other: Shared-decision making process

Standard decision making for care

OTHER

Other: standard care

Interventions

Shared-decision making process OTHER

Completion of the Ottawa Personal Decision Guide to help guide care with the support of online and printed material describing the therapeutic options available

Shared Decision making for care

standard care OTHER

Care of patients according to standard practice of managing patients with bipolar disorder

Standard decision making for care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The subject is participating in an interventional study, or has participated in another interventional study within the previous 3 months
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (16)

Ch Beziers

Béziers, 34500, France

Location

CH Charles Perrens

Bordeaux, 33076, France

Location

CH le Vinatier

Bron, 69678, France

Location

CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

Clermont-Ferrand, 63003, France

Location

Chu Gabriel Montpied Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

CH Sainte-Marie de Clermont-Ferrand

Clermont-Ferrand, 63037, France

Location

APHP - Centre Hospitalier Henri Mondor

Créteil, 94010, France

Location

CHU de Grenoble - Hôpital Albert Michallon

Grenoble, 38043, France

Location

CH Limoges

Limoges, 87025, France

Location

APHM - Hôpital Sainte-Marguerite

Marseille, 13274, France

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHU Nancy

Nancy, 54000, France

Location

CHU Nantes

Nantes, 44000, France

Location

Clinique des troubles thymiques

Nîmes, 30000, France

Location

CHU Nimes

Nîmes, 30029, France

Location

APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal

Paris, 75475, France

Location

Related Publications (1)

• 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.

  PMID: 29653535 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ludovic Samalin

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Study Start: April 24, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-02

Locations

FR (16)