One-day psychoeducation program for caregivers of bipolar disorder patients
Evaluation of the Effectiveness of a Day Patient-caregiver Psychoeducationnal Program on the Burden of Caregivers
This study tests whether a one-day education program can help caregivers of people with bipolar disorder feel less burdened and more informed about the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05178966 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a one-day psychoeducational program designed for caregivers of individuals with bipolar disorder. The program aims to reduce caregiver burden and stigma while improving knowledge about bipolar disorder, medication adherence, and quality of life. Participants will be randomly assigned to either the intervention group, which receives the psychoeducation, or a control group on a waiting list. The effectiveness will be measured using the Zarit Caregiver Burden Interview and other relevant assessments over a one-month period.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who have a diagnosis of bipolar disorder and have a designated caregiver.
Not a fit: Patients who are unable to adhere to group requirements or have cognitive disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly alleviate the burden and stigma faced by caregivers of bipolar disorder patients.
How similar studies have performed: Previous studies have shown that psychoeducation can effectively reduce caregiver burden, suggesting that this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier
- University Hospital of Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Kathlyne DUPUIS MAURIN
- Email: k-dupuis@chu-montpellier.fr
- Phone: +33467335663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.