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

NCT05178966 | Recruiting

• 1 other identifier: 2021-A01317-34
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Caregiver Burden

Keywords

bipolar disorder; psychoeducation; caregivers; burden; stigmatization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• caregivers stigmatization

  Day44 for experimental group, Day14 for control group

• caregivers stigmatization

  Day65 for experimental group, Day35 for control group

• Internalized Stigma of patients

  Day44 for experimental group, Day14 for control group

• Internalized Stigma of patients

  Day65 for experimental group, Day35 for control group

• Patient quality of life

  Day44 for experimental group, Day14 for control group

Study Arms (2)

Bp OneDay programm

EXPERIMENTAL

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

Behavioral: Bp OneDay psychoeducation program

Waiting List

NO INTERVENTION

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.

Interventions

Bp OneDay psychoeducation program 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.

Bp OneDay programm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 not having signed an informed consent
• Subject not affiliated with a social security scheme or such a scheme
• 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;
• 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 not having signed an informed consent
• Subject not affiliated with a social security scheme or such a scheme

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder; Caregiver Burden; Stereotyping

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Social Behavior

Central Study Contacts

Kathlyne DUPUIS MAURIN

CONTACT

+33467335663; k-dupuis@chu-montpellier.fr

Maude SENEQUE

CONTACT

+33467335663; m-senequehaize@chu-montpellier.fr

Study Design

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

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: January 5, 2022
• Study Start: November 9, 2022
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

FR (1)