Clinical trial NCT05178966: Evaluation of Efficiency of One Day Patient/Caregiver Psychoeducation on the Caregiver's Burden
Official title: Evaluation of the Effectiveness of a Day Patient-caregiver Psychoeducationnal Program on the Burden of Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Caregiver Burden
Keywords: bipolar disorder
psychoeducation
caregivers
burden
stigmatization
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Bipolar disorder (BD) has a huge impact on the lives of patient and their relatives. Psychoeducation programs on BD has been shown to be effective on the burden of patients and their caregivers. However, actual programs appear to be incompatible with patients obligations and services requirements of the service. The development of "minute" programs (in one day) is justified.

Detailed description: Bipolar disorder (BD) has a huge impact on patient lives and their relatives. BD psychoeducation has been shown to be effective on patient disease course and caregivers burden. However, the programs offered appear to be incompatible with the participants obligations and services requirements. In this context we wanted to develop a "minute" program (Bp one day).

Study participation includes 3 visits : inclusion visit and 2 follow up visits.

The main objective is to assess the effectiveness of day psychoeducational program (BP OneDay) on caregiver burden at one month according to the Zarit Caregiver Burden Interview (ZCBI) total score.

This study also aims to assess the effectiveness of BP OneDay on caregiver stigma, patient self-stigma and medication adherence, quality of life, and bipolar disorder knowledge.

The study is an open-label randomized controlled trial with two arms

Overall, 120 dyads will be recruited randomly affected in 2 groups :

* the interventional group will benefit from a day psychoeducational program : Bp oneDay
* the control group will be placed on the waiting list

The benefits expected from Bp OneDay are to reduce caregiver burden and stigma and improve knowledge about BD. For patients, we expect improve disease understanding, drug adherence and reduce self-stigmatization. If the results are promising, this program can be widely disseminated and thus increase cares' solution for patients and relatives in large urban centers.

Eligibility criteria: Patient inclusion Criteria:

* Be over 18 years old;
* Meet the criteria for bipolar disorder (I, II, unspecified) according to the DSM-5 criteria;
* Be able to understand the nature, purpose and methodology of the study;
* Presence of a caregiver

Patient Exclusion Criteria:

* Subject unable to adhere to the group requirements (cognitive disorder, decompensated mood state ...);
* Subject protected by law (subject under guardianship and / or guardianship) or deprived of liberty by a judicial or administrative decision;
* Subject unable to understand, speak and write French;
* Subject in a period of exclusion from another protocol.
* Subject not having signed an informed consent
* Subject not affiliated with a social security scheme or such a scheme

Caregiver inclusion criteria ;

* Subject over 18 years old;
* Subject designated as a regular caregiver of a patient with bipolar disorder. A regular caregiver is a trusted person designated by the patient as being one of his main support, having knowledge of the diagnosis of bipolar disorder and who can be called upon in the context of care.
* Subject able to understand the nature, purpose and methodology of the study;

Caregiver exclusion criteria :

* Subject unable to adhere to the groupre quirements (cognitive disorder, decompensated mood state ...);
* Subject protected by law (subject under guardianship and / or curatorship) or deprived of liberty by a judicial or administrative decision ;
* Subject unable to understand, speak and write French;
* Subject in a period of exclusion from another protocol.
* Subject not having signed an informed consent
* Subject not affiliated with a social security scheme or such a scheme

Primary outcomes:
measure: caregivers burden
timeFrame: Day65 for experimental group, Day35 for control group
Secondary outcomes:
measure: caregivers stigmatization
timeFrame: Day44 for experimental group, Day14 for control group
measure: caregivers stigmatization
timeFrame: Day65 for experimental group, Day35 for control group
measure: Internalized Stigma of patients
timeFrame: Day44 for experimental group, Day14 for control group
measure: Internalized Stigma of patients
timeFrame: Day65 for experimental group, Day35 for control group
measure: Patient quality of life
timeFrame: Day44 for experimental group, Day14 for control group
measure: Patient quality of life
timeFrame: Day65 for experimental group, Day35 for control group
measure: caregivers quality of life
timeFrame: Day44 for experimental group, Day14 for control group
measure: caregivers quality of life
timeFrame: Day65 for experimental group, Day35 for control group
measure: Medication Adherence
timeFrame: Day44 for experimental group, Day14 for control group
measure: Medication Adherence
timeFrame: Day65 for experimental group, Day35 for control group
measure: Bipolar disorder Knowledge in patients
timeFrame: Day44 for experimental group, Day14 for control group
measure: Bipolar disorder Knowledge in patients
timeFrame: Day65 for experimental group, Day35 for control group
measure: Bipolar disorder Knowledge in caregivers
timeFrame: Day44 for experimental group, Day14 for control group
measure: Bipolar disorder Knowledge in caregivers
timeFrame: Day65 for experimental group, Day35 for control group
measure: Patient satisfaction
timeFrame: Day44 for experimental group, Day14 for control group
measure: caregiver satisfaction
timeFrame: Day44 for experimental group, Day14 for control group
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
References: