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Active, Not Recruiting

NCT Number: NCT03245593

Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Charles Perrens, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Standard care

Other

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

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.

    Time frame: 12 months

    Clinician Rating Scale (1-7)

Secondary outcomes

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

    Time frame: 3 months

    Clinician Rating Scale (1-7)

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

    Time frame: 6 months

    Clinician Rating Scale (1-7)

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

    Time frame: 9 months

    Clinician Rating Scale (1-7)

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

    Time frame: 3 months

    Medication Adherence Rating Scale( 0-10),

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

    Time frame: 6 months

    Medication Adherence Rating Scale( 0-10),

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

    Time frame: 9 months

    Medication Adherence Rating Scale( 0-10),

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

    Time frame: 12 months

    Medication Adherence Rating Scale( 0-10),

  8. Clinical evaluation of the difference between the 2 groups in medication adherence

    Time frame: 3 months

    Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants

  9. Clinical evaluation of the difference between the 2 groups in medication adherence

    Time frame: 6 months

    Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants

  10. Clinical evaluation of the difference between the 2 groups in medication adherence

    Time frame: 9 months

    Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants

  11. Clinical evaluation of the difference between the 2 groups in medication adherence

    Time frame: 12 months

    Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants

  12. Compare difference in the adherence to personalized follow-up between groups

    Time frame: 3 months

    percentage of consultations missed

  13. Compare difference in the adherence to personalized follow-up between groups

    Time frame: 6 months

    percentage of consultations missed

  14. Compare difference in the adherence to personalized follow-up between groups

    Time frame: 9 months

    percentage of consultations missed

  15. Compare difference in the adherence to personalized follow-up between groups

    Time frame: 12 months

    percentage of consultations missed

  16. Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups

    Time frame: 3 months

    decisional conflict scale (0-100)

  17. Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups

    Time frame: 6 months

    decisional conflict scale (0-100)

  18. Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups

    Time frame: 9 months

    decisional conflict scale (0-100)

  19. Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups

    Time frame: 12 months

    decisional conflict scale (0-100)

  20. Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups

    Time frame: 3 months

    adapted QSH-45: 3 questions scored 1-5

  21. Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups

    Time frame: 6 months

    adapted QSH-45: 3 questions scored 1-5

  22. Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups

    Time frame: 9 months

    adapted QSH-45: 3 questions scored 1-5

  23. Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups

    Time frame: 12 months

    adapted QSH-45: 3 questions scored 1-5

  24. Compare difference in patient satisfaction concerning the decision-making process between groups

    Time frame: 3 months

    Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5

  25. Compare difference in patient satisfaction concerning the decision-making process between groups

    Time frame: 6 months

    Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5

  26. Compare difference in patient satisfaction concerning the decision-making process between groups

    Time frame: 9 months

    Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5

  27. Compare difference in patient satisfaction concerning the decision-making process between groups

    Time frame: 12 months

    Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5

  28. Compare difference in therapeutic alliance between groups

    Time frame: 3 months

    4-Point ordinal Alliance Scale

  29. Compare difference in therapeutic alliance between groups

    Time frame: 6 months

    4-Point ordinal Alliance Scale

  30. Compare difference in therapeutic alliance between groups

    Time frame: 9 months

    4-Point ordinal Alliance Scale

  31. Compare difference in therapeutic alliance between groups

    Time frame: 12 months

    4-Point ordinal Alliance Scale

  32. Compare difference in knowledge of disease and treatment necessary to making decisions between groups

    Time frame: 3 months

    Knowledge questionnaire: % correct answers

  33. Compare difference in knowledge of disease and treatment necessary to making decisions between groups

    Time frame: 6 months

    Knowledge questionnaire: % correct answers

  34. Compare difference in knowledge of disease and treatment necessary to making decisions between groups

    Time frame: 9 months

    Knowledge questionnaire: % correct answers

  35. Compare difference in knowledge of disease and treatment necessary to making decisions between groups

    Time frame: 12 months

    Knowledge questionnaire: % correct answers

  36. Compare difference in patient attitude towards the treatment between groups

    Time frame: 3 months

    Beliefs about Medicines Questionnaire: 18 questions 1-5

  37. Compare difference in patient attitude towards the treatment between groups

    Time frame: 6 months

    Beliefs about Medicines Questionnaire: 18 questions 1-5

  38. Compare difference in patient attitude towards the treatment between groups

    Time frame: 9 months

    Beliefs about Medicines Questionnaire: 18 questions 1-5

  39. Compare difference in patient attitude towards the treatment between groups

    Time frame: 12 months

    Beliefs about Medicines Questionnaire: 18 questions 1-5

  40. Compare number and duration of mood episodes between groups months

    Time frame: 3 months

    number of events; number of days

  41. Compare number and duration of mood episodes between groups months

    Time frame: 6 months

    number of events; number of days

  42. Compare number and duration of mood episodes between groups months

    Time frame: 9 months

    number of events; number of days

  43. Compare number and duration of mood episodes between groups months

    Time frame: 12 months

    number of events; number of days

  44. Compare number and duration of hospitalizations in psychiatric service between groups

    Time frame: 3 months

    number of events; number of days

  45. Compare number and duration of hospitalizations in psychiatric service between groups

    Time frame: 6 months

    number of events; number of days

  46. Compare number and duration of hospitalizations in psychiatric service between groups

    Time frame: 9 months

    number of events; number of days

  47. Compare number and duration of hospitalizations in psychiatric service between groups

    Time frame: 12 months

    number of events; number of days

  48. Compare manic symptomatology during evaluations between groups

    Time frame: 3 months

    Young Mania Rating Scale

  49. Compare manic symptomatology during evaluations between groups

    Time frame: 6 months

    Young Mania Rating Scale

  50. Compare manic symptomatology during evaluations between groups

    Time frame: 9 months

    Young Mania Rating Scale

  51. Compare manic symptomatology during evaluations between groups

    Time frame: 12 months

    Young Mania Rating Scale

  52. Compare the depressive symptomatology during evaluations between groups

    Time frame: 3 months

    Montgomery-Asberg Depression Rating Scale

  53. Compare the depressive symptomatology during evaluations between groups

    Time frame: 6 months

    Montgomery-Asberg Depression Rating Scale

  54. Compare the depressive symptomatology during evaluations between groups

    Time frame: 9 months

    Montgomery-Asberg Depression Rating Scale

  55. Compare the depressive symptomatology during evaluations between groups

    Time frame: 12 months

    Montgomery-Asberg Depression Rating Scale

  56. Compare severity and intensity of suicidal ideas between groups

    Time frame: 3 months

    Columbia-Suicide Severity Rating Scale

  57. Compare severity and intensity of suicidal ideas between groups

    Time frame: 6 months

    Columbia-Suicide Severity Rating Scale

  58. Compare severity and intensity of suicidal ideas between groups

    Time frame: 9 months

    Columbia-Suicide Severity Rating Scale

  59. Compare severity and intensity of suicidal ideas between groups

    Time frame: 12 months

    Columbia-Suicide Severity Rating Scale

  60. Compare the psychosocial functioning between groups

    Time frame: 3 months

    Functioning Assessment Short Test (0-72)

  61. Compare the psychosocial functioning between groups

    Time frame: 6 months

    Functioning Assessment Short Test (0-72)

  62. Compare the psychosocial functioning between groups

    Time frame: 9 months

    Functioning Assessment Short Test (0-72)

  63. Compare the psychosocial functioning between groups

    Time frame: 12 months

    Functioning Assessment Short Test (0-72)

  64. Compare quality of life between groups

    Time frame: 3 months

    WHOQOL-BREF (0-100)

  65. Compare quality of life between groups

    Time frame: 6 months

    WHOQOL-BREF (0-100)

  66. Compare quality of life between groups

    Time frame: 9 months

    WHOQOL-BREF (0-100)

  67. Compare quality of life between groups

    Time frame: 12 months

    WHOQOL-BREF (0-100)

  68. Compare length of consultations between groups

    Time frame: every consultation for 12 months

    minutes

  69. Clinician satisfaction concerning the therapeutic decisions taken between groups

    Time frame: 3 months

    adapted QSH-45 doctor version 3 questions scored 1-5

  70. Clinician satisfaction concerning the therapeutic decisions taken between groups

    Time frame: 6 months

    adapted QSH-45 doctor version 3 questions scored 1-5

  71. Clinician satisfaction concerning the therapeutic decisions taken between groups

    Time frame: 9 months

    adapted QSH-45 doctor version 3 questions scored 1-5

  72. Clinician satisfaction concerning the therapeutic decisions taken between groups

    Time frame: 12 months

    adapted QSH-45 doctor version 3 questions scored 1-5

  73. Clinician satisfaction concerning the decision-making process between groups

    Time frame: 3 months

    Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5

  74. Clinician satisfaction concerning the decision-making process between groups

    Time frame: 6 months

    Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5

  75. Clinician satisfaction concerning the decision-making process between groups

    Time frame: 9 months

    Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5

  76. Clinician satisfaction concerning the decision-making process between groups

    Time frame: 12 months

    Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5

  77. Clinician perceptions related to the uncertainty of the medical decisions taken between groups

    Time frame: 3 months

    decisional conflict scale doctor version (0-100)

  78. Clinician perceptions related to the uncertainty of the medical decisions taken between groups

    Time frame: 6 months

    decisional conflict scale doctor version (0-100)

  79. Clinician perceptions related to the uncertainty of the medical decisions taken between groups

    Time frame: 9 months

    decisional conflict scale doctor version (0-100)

  80. Clinician perceptions related to the uncertainty of the medical decisions taken between groups

    Time frame: 12 months

    decisional conflict scale doctor version (0-100)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: ShareD-BD

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Aug 10, 2017
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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