An E-health Psychoeducation Program to Manage Symptoms During COVID-19 Pandemic for People With Bipolar Disorders: a Randomized Controlled Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- University of Cagliari
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Generalized Anxiety Disorder (GAD-7)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Mauro Giovanni Carta
Principal Investigator
University of Cagliari
Eligibility Criteria
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
Outcomes
Primary Outcomes
Generalized Anxiety Disorder (GAD-7)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.