Bipolar Disorder, COVID-19 Pandemic, Psychoeducation
Conditions
Keywords
Bipolar Disorder, Psychoeducation, COVID-19 Pandemic
Brief summary
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
Detailed description
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.
Interventions
OTHERe-health psychoeducation
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.
Sponsors
Alessandra Perra
University of Cagliari
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label cross-over randomized controlled trial (two arms)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder (GAD-7) | T0 (0 weeks); T1 (8 weeks); T2 (16 weeks) | GAD-7 is 7 item self-administered questionnaire evaluates symptoms of an anxiety disorder |
| Hamilton Depression Rating Scale (HDRS21) | T0 (0 weeks); T1 (8 weeks); T2 (16 weeks) | Depressive symptoms were assessed using HDRS21 consists of 21 items, and the total score allows for the assignment of severity scores for the symptoms |
| Short Form Health Survey (SF-12) | T0 (0 weeks); T1 (8 weeks); T2 (16 weeks) | SF12 is a self-administered questionnaire consisting of 12 items that assess two dimensions: physical health and mental health to establish poor/good QoL. |
| Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) | T0 (0 weeks); T1 (8 weeks); T2 (16 weeks) | 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. |
Countries
Italy
Outcome results
None listed