Trials / Recruiting
RecruitingNCT05178966
Evaluation of Efficiency of One Day Patient/Caregiver Psychoeducation on the Caregiver's Burden
Evaluation of the Effectiveness of a Day Patient-caregiver Psychoeducationnal Program on the Burden of Caregivers
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- University Hospital, Montpellier · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-11-09
- Primary completion
- 2025-11-30
- Completion
- 2025-11-30
- First posted
- 2022-01-05
- Last updated
- 2024-08-09
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05178966. Inclusion in this directory is not an endorsement.