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Completed

NCT Number: NCT06296784

An E-health Psychoeducation for People With Bipolar Disorders

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

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders COVID-19 COVID-19 Pandemic Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Mood Disorders Nidovirales Infections Pneumonia Pneumonia, Viral Psychoeducation RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Giovanni di Dio Hospital

Cagliari, CA, 09100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Generalized Anxiety Disorder (GAD-7)

    Time frame: T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)

    GAD-7 is 7 item self-administered questionnaire evaluates symptoms of an anxiety disorder

  2. Hamilton Depression Rating Scale (HDRS21)

    Time frame: 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

  3. Short Form Health Survey (SF-12)

    Time frame: 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.

  4. Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Collaborators

  • Alessandra Perra

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 6, 2024
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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