Evaluation of Efficiency of One Day Patient/Caregiver Psychoeducation on the Caregiver's Burden (BP ONEDAY)

Evaluation of the Effectiveness of a Day Patient-caregiver Psychoeducationnal Program on the Burden of Caregivers

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder; Caregiver Burden
• Intervention / Treatment: Behavioral: Bp OneDay psychoeducation program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathlyne DUPUIS MAURIN; Phone Number: +33467335663; Email: k-dupuis@chu-montpellier.fr
• Study Contact Backup: Name: maude SENEQUE; Phone Number: +33467335663; Email: m-senequehaize@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • University Hospital of Montpellier
    • Contact: Gaëlle MARTINEZ-TARQUINI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bp OneDay programm; The BP One-Day program is based on a single day of psychoeducation .	Behavioral: 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.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
caregivers burden	evaluation of caregiver burden based on the Zarit Caregiver Burden Interview total score. The Zarit Caregiver Burden Interview is a self-administered questionnaire assessing caregiver burden using 22 items. Five themes are examined: psychological and physical suffering, financial, relational and social difficulties. For each of the 22 items, the caregiver determines how often he feels a given emotion in the helping relationship. This frequency ranges from 0 "never" to 4 "Almost always". The overall score is obtained by adding all the items together, it varies from 0 to 88. The higher the score, the greater the burden felt by the caregiver.	Day65 for experimental group, Day35 for control group

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
caregivers stigmatization	évaluation of caregivers stigmatization using Affiliate stigma scale on caregivers of people with mental illness The Affiliate stigma scale on caregivers of people with mental illness is a self-questionnaire composed of 22 items assessing 3 dimensions of stigma : the cognitive, affective and behavioral dimension. Participants are asked to rate their level of agreement with the statements on a 4-point Likert scale (ranging from 1 "Strongly disagree" to 4 "Strongly agree). The total score ranges from 22 to 88. The higher the score, the more severe the stigma.	Day44 for experimental group, Day14 for control group
caregivers stigmatization	évaluation of caregivers stigmatization using Affiliate stigma scale on caregivers of people with mental illness The Affiliate stigma scale on caregivers of people with mental illness is a self-questionnaire composed of 22 items assessing 3 dimensions of stigma : the cognitive, affective and behavioral dimension. Participants are asked to rate their level of agreement with the statements on a 4-point Likert scale (ranging from 1 "Strongly disagree" to 4 "Strongly agree). The total score ranges from 22 to 88. The higher the score, the more severe the stigma.	Day65 for experimental group, Day35 for control group
Internalized Stigma of patients	evaluation of Internalized Stigma according to the Internalized Stigma of Mental Illness total score This self-questionnaire consists of 29 items. Each item is rated using a 4-points Likert scale ranging from 1 "Strongly disagree" to 4 "Strongly agree". The 29 items are grouped according to 5 themes: alienation (the fact of not feeling a full member of the society in which we live), approval of stereotypes, perceived discrimination, social withdrawal, and resistance to stigma. The higher the score, the more severe the self-stigma.	Day44 for experimental group, Day14 for control group
Internalized Stigma of patients	evaluation of Internalized Stigma according to the Internalized Stigma of Mental Illness total score This self-questionnaire consists of 29 items. Each item is rated using a 4-points Likert scale ranging from 1 "Strongly disagree" to 4 "Strongly agree". The 29 items are grouped according to 5 themes: alienation (the fact of not feeling a full member of the society in which we live), approval of stereotypes, perceived discrimination, social withdrawal, and resistance to stigma. The higher the score, the more severe the self-stigma.	Day65 for experimental group, Day35 for control group
Patient quality of life	Evaluation of patient quality of life according to the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form total score. This 16-items self-administered questionnaire assesses the quality of life through the assessment of physical health, social relationships, family relationships, mood, libido, the ability to function on a daily basis, the ability to invest and enjoy leisure time, to work, the economic level, the place of life and the general feeling of well-being. The last two items assess satisfaction with treatment as well as satisfaction with life and are treated independently of the others. Each item is scored on a 5-point Likert scale and represents the level of satisfaction experienced over the last week. A calculation of the overall score is performed for items 1 to 14 (ranging from 14 to 70) and is expressed as a percentage (0-100). The higher the score, the better the quality of life.	Day44 for experimental group, Day14 for control group
Patient quality of life	Evaluation of patient quality of life according to the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form total score. This 16-items self-administered questionnaire assesses the quality of life through the assessment of physical health, social relationships, family relationships, mood, libido, the ability to function on a daily basis, the ability to invest and enjoy leisure time, to work, the economic level, the place of life and the general feeling of well-being. The last two items assess satisfaction with treatment as well as satisfaction with life and are treated independently of the others. Each item is scored on a 5-point Likert scale and represents the level of satisfaction experienced over the last week. A calculation of the overall score is performed for items 1 to 14 (ranging from 14 to 70) and is expressed as a percentage (0-100). The higher the score, the better the quality of life.	Day65 for experimental group, Day35 for control group
caregivers quality of life	Evaluation of caregivers quality of life according to the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form total score. This 16-items self-administered questionnaire assesses the quality of life through the assessment of physical health, social relationships, family relationships, mood, libido, the ability to function on a daily basis, the ability to invest and enjoy leisure time, to work, the economic level, the place of life and the general feeling of well-being. The last two items assess satisfaction with treatment as well as satisfaction with life and are treated independently of the others. Each item is scored on a 5-point Likert scale and represents the level of satisfaction experienced over the last week. A calculation of the overall score is performed for items 1 to 14 (ranging from 14 to 70) and is expressed as a percentage (0-100). The higher the score, the better the quality of life.	Day44 for experimental group, Day14 for control group
caregivers quality of life	Evaluation of caregivers quality of life according to the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form total score. This 16-items self-administered questionnaire assesses the quality of life through the assessment of physical health, social relationships, family relationships, mood, libido, the ability to function on a daily basis, the ability to invest and enjoy leisure time, to work, the economic level, the place of life and the general feeling of well-being. The last two items assess satisfaction with treatment as well as satisfaction with life and are treated independently of the others. Each item is scored on a 5-point Likert scale and represents the level of satisfaction experienced over the last week. A calculation of the overall score is performed for items 1 to 14 (ranging from 14 to 70) and is expressed as a percentage (0-100). The higher the score, the better the quality of life.	Day65 for experimental group, Day35 for control group
Medication Adherence	Evaluation of patient medication adherence according to Medication Adherence Rating Scale total score. This self-questionnaire has 10 yes / no items. The total score varies between 0 and 10. The higher the score, the better the compliance. This scale was created and is widely used in the psychiatric population.	Day44 for experimental group, Day14 for control group
Medication Adherence	Evaluation of patient medication adherence according to Medication Adherence Rating Scale total score. This self-questionnaire has 10 yes / no items. The total score varies between 0 and 10. The higher the score, the better the compliance. This scale was created and is widely used in the psychiatric population.	Day65 for experimental group, Day35 for control group
Bipolar disorder Knowledge in patients	Evaluation of Bipolar Disorde knowledge in patients according to "Quizz BP" total score. This self-administered questionnaire is composed of twenty true or false questions. It addresses different themes: occurrence, etiology, semiology, factors triggering episodes, comorbidities, treatments. The overall score fluctuates between 0 and 20. Although this test has not been validated, it has already been used in several published works	Day44 for experimental group, Day14 for control group
Bipolar disorder Knowledge in patients	Evaluation of Bipolar Disorde knowledge in patients according to "Quizz BP" total score. This self-administered questionnaire is composed of twenty true or false questions. It addresses different themes: occurrence, etiology, semiology, factors triggering episodes, comorbidities, treatments. The overall score fluctuates between 0 and 20. Although this test has not been validated, it has already been used in several published works	Day65 for experimental group, Day35 for control group
Bipolar disorder Knowledge in caregivers	Evaluation of Bipolar Disorde knowledge in caregivers according to "Quizz BP" total score. This self-administered questionnaire is composed of twenty true or false questions. It addresses different themes: occurrence, etiology, semiology, factors triggering episodes, comorbidities, treatments. The overall score fluctuates between 0 and 20. Although this test has not been validated, it has already been used in several published works	Day44 for experimental group, Day14 for control group
Bipolar disorder Knowledge in caregivers	Evaluation of Bipolar Disorde knowledge in caregivers according to "Quizz BP" total score. This self-administered questionnaire is composed of twenty true or false questions. It addresses different themes: occurrence, etiology, semiology, factors triggering episodes, comorbidities, treatments. The overall score fluctuates between 0 and 20. Although this test has not been validated, it has already been used in several published works	Day65 for experimental group, Day35 for control group
Patient satisfaction	Evaluation of patient satisfaction with the group according to a liker score ranged from 0 "absolutely not satisfied" to 10 "Extremely satisfied"	Day44 for experimental group, Day14 for control group
caregiver satisfaction	Evaluation of caregiver satisfaction with the group according to a liker score ranged from 0 "absolutely not satisfied" to 10 "Extremely satisfied"	Day44 for experimental group, Day14 for control group

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2022
• Primary Completion (ANTICIPATED): May 31, 2024
• Study Completion (ANTICIPATED): May 31, 2024

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (ACTUAL): January 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: bipolar disorder; caregivers; psychoeducation; burden; stigmatization
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Stress, Psychological; Bipolar and Related Disorders; Bipolar Disorder; Caregiver Burden
• Other Study ID Numbers: 2021-A01317-34 (OTHER: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No