Clinical Trials Directory

Trials / Completed

CompletedNCT06296784

An E-health Psychoeducation for People With Bipolar Disorders

An E-health Psychoeducation Program to Manage Symptoms During COVID-19 Pandemic for People With Bipolar Disorders: a Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
University of Cagliari · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERe-health psychoeducatione-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.

Timeline

Start date
2021-05-26
Primary completion
2021-11-15
Completion
2021-11-15
First posted
2024-03-06
Last updated
2024-04-05

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06296784. Inclusion in this directory is not an endorsement.