An E-health Psychoeducation for People With Bipolar Disorders

NCT06296784 | Completed

• 1 other identifier: PG/2021/8551
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Bipolar Disorder; Psychoeducation; COVID-19 Pandemic

Keywords

Bipolar Disorder; Psychoeducation; COVID-19 Pandemic

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

e-health psychoeducation

EXPERIMENTAL

Other: e-health psychoeducation

waiting list

NO INTERVENTION

Interventions

e-health psychoeducation OTHER

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.

e-health psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of BD according to DSM-V, over 18 years old

You may not qualify if:

• do not have bipolar disorder, refusal to participate in the study

Sponsors & Collaborators

• University of Cagliari: lead
• Alessandra Perra: collaborator

Study Sites (1)

San Giovanni di Dio Hospital

Cagliari, CA, 09100, Italy

Location

MeSH Terms

Conditions

Bipolar Disorder; COVID-19

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open-label cross-over randomized controlled trial (two arms)

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: May 26, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)