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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06296784
Other study ID # PG/2021/8551
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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