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| Name | Class |
|---|---|
| Alessandra Perra | UNKNOWN |
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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
Biological rhythms significantly impact individuals' quality of life (QoL). During the COVID-19 pandemic, social rhythm dysregulation was identified as a contributing factor to relapses in Bipolar Disorder (BD). This trial aims to present data on the efficacy of an e-health psychoeducational intervention for BD in improving anxiety, depressive symptoms, QoL, biological rhythms, and the correlations between QoL and biorhythms.
This study employs a cross-over randomized controlled trial design. Inclusion criteria include a diagnosis of BD according to Diagnostic and Statistical Manual of mental disorders (DSM-V) criteria, age over 18, and obtaining informed consent.
The intervention consists of e-health psychoeducation aimed at reducing distress levels associated with the Covid-19 pandemic and the implemented restrictive measures (lockdown). The focus is on strategies to manage the dysregulation of biological rhythms, with one session per week over two months. Each session lasts approximately an hour and a half and is conducted by a team comprising psychologists, psychiatric rehabilitation technicians, and professional health educators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| e-health psychoeducation | Experimental |
| |
| waiting list | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-health psychoeducation | Other | e-health psychoeducation intervention provides information about BD clinical condition and symptoms, as well as identifying effective coping strategies to manage symptoms and the dysregulation of biological rhythms. The content covered the impact of the pandemic and its related restrictions on mental health, particularly on anxiety and depressive symptoms. The intervention comprised one session per week for two months, and each session lasted approximately an hour and a half. It was conducted by healthcare professionals. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Giovanni di Dio Hospital | Cagliari | CA | 09100 | Italy |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
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Open-label cross-over randomized controlled trial (two arms)
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|
| D011014 |
| Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |