An E-health Psychoeducation for People With Bipolar Disorders

Not Applicable

Completed

• Conditions: Bipolar Disorder; COVID-19 Pandemic; Psychoeducation
• Interventions: Other: e-health psychoeducation

• Registration Number: NCT06296784
• Lead Sponsor: University of Cagliari

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.

Study Timeline

• Study Start: 2021-05-26
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
e-health psychoeducation	e-health psychoeducation	-

Primary Outcome Measures

Name	Time	Method
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
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.
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
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.

Trial Locations

Locations (1)

San Giovanni di Dio Hospital; 🇮🇹 Cagliari, CA, Italy