Bipolar Disorder Clinical Trial
Official title:
An E-health Psychoeducation Program to Manage Symptoms During COVID-19 Pandemic for People With Bipolar Disorders: a Randomized Controlled Study
Verified date | April 2024 |
Source | University of Cagliari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to present data on the improvement of Quality of life (QoL), biological rhythms, anxiety, depressive symptoms and the correlations between QoL and biorhythms following an e-health psychoeducational intervention for Bipolar Disoirder (BD) during Covid-19 pandemic
Status | Completed |
Enrollment | 36 |
Est. completion date | November 15, 2021 |
Est. primary completion date | November 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - diagnosis of BD according to DSM-V, over 18 years old Exclusion Criteria: - do not have bipolar disorder, refusal to participate in the study |
Country | Name | City | State |
---|---|---|---|
Italy | San Giovanni di Dio Hospital | Cagliari | CA |
Lead Sponsor | Collaborator |
---|---|
University of Cagliari | Alessandra Perra |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Generalized Anxiety Disorder (GAD-7) | GAD-7 is 7 item self-administered questionnaire evaluates symptoms of an anxiety disorder | T0 (0 weeks); T1 (8 weeks); T2 (16 weeks) | |
Primary | Hamilton Depression Rating Scale (HDRS21) | Depressive symptoms were assessed using HDRS21 consists of 21 items, and the total score allows for the assignment of severity scores for the symptoms | T0 (0 weeks); T1 (8 weeks); T2 (16 weeks) | |
Primary | Short Form Health Survey (SF-12) | SF12 is a self-administered questionnaire consisting of 12 items that assess two dimensions: physical health and mental health to establish poor/good QoL. | T0 (0 weeks); T1 (8 weeks); T2 (16 weeks) | |
Primary | Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) | BRIAN is a interview consisting of 18 items that investigate four main areas related to the dysregulation of biological rhythms: sleeping, activity, social rhythms, and eating. | T0 (0 weeks); T1 (8 weeks); T2 (16 weeks) |
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