Evaluation of Efficiency of One Day Patient/Caregiver Psychoeducation on the Caregiver's Burden

NCT ID: NCT05178966

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-09
• Study Completion Date: 2025-11-30

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.

Conditions

Bipolar Disorder; Caregiver Burden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Bp OneDay programm

The BP One-Day program is based on a single day of psychoeducation .

Group Type: EXPERIMENTAL

Bp OneDay psychoeducation program

Intervention Type: BEHAVIORAL

The BP One-Day Psychoeducation program is based on a single day of psychoeducation . This program was carried out by members of the bipolar expert center network in various hospitals of the network and included :

• Representation of BD
• Definition, diagnosis and awareness of the disorder
• Depressive, hypo / manic symptoms
• Vulnerability to BD causes of BD, risk factors for relapses
• Drug treatments, drug compliance and non-drug treatments
• Early detection of prodromal signs
• Communication techniques

Each BP One-Day psychoeducation session welcomes an average of ten participants (5 patients / 5 caregivers). At the end of the day, participants receive a booklet containing the main information of the day.

BP One-Day program is delivered by a nurse and a psychologist specialized in both BD and therapy group facilitation. A specialized psychiatrist intervenes in the section "Medication treatments and medication adherence" for a period of approximately one hour.

Waiting List

Patients assigned in control group will be placed in waiting list and will benefit from the program after their participation to this study. During study participation, they will receive treatment as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bp OneDay psychoeducation program

The BP One-Day Psychoeducation program is based on a single day of psychoeducation . This program was carried out by members of the bipolar expert center network in various hospitals of the network and included :

• Representation of BD
• Definition, diagnosis and awareness of the disorder
• Depressive, hypo / manic symptoms
• Vulnerability to BD causes of BD, risk factors for relapses
• Drug treatments, drug compliance and non-drug treatments
• Early detection of prodromal signs
• Communication techniques

Each BP One-Day psychoeducation session welcomes an average of ten participants (5 patients / 5 caregivers). At the end of the day, participants receive a booklet containing the main information of the day.

BP One-Day program is delivered by a nurse and a psychologist specialized in both BD and therapy group facilitation. A specialized psychiatrist intervenes in the section "Medication treatments and medication adherence" for a period of approximately one hour.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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;

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Kathlyne DUPUIS MAURIN

Role: CONTACT

k-dupuis@chu-montpellier.fr

+33467335663

Maude SENEQUE

Role: CONTACT

m-senequehaize@chu-montpellier.fr

+33467335663

Facility Contacts

Gaëlle MARTINEZ-TARQUINI

Role: primary

Other Identifiers

2021-A01317-34

Identifier Type: OTHER

Identifier Source: secondary_id

2021-A01317-34

Identifier Type: -

Identifier Source: org_study_id