An E-health Psychoeducation for People With Bipolar Disorders

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06296784
• Other study ID #: PG/2021/8551
• Status: Completed
• Phase: N/A
• Start date: May 26, 2021
• Est. completion date: November 15, 2021

Study information

• Verified date: April 2024
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bipolar Disorder
• COVID-19
• COVID-19 Pandemic
• Psychoeducation

Intervention

Other:
• e-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.

Locations

Country	Name	City	State
Italy	San Giovanni di Dio Hospital	Cagliari	CA

Sponsors (2)

Lead Sponsor	Collaborator
University of Cagliari	Alessandra Perra

Country where clinical trial is conducted

Italy, 

Outcome

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)