- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06296784
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
CA
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Cagliari, CA, Italy, 09100
- San Giovanni di Dio Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: waiting list
|
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Experimental: e-health psychoeducation
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
|
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
|
T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
|
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.
|
T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
|
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.
|
T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Mood Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Bipolar and Related Disorders
- COVID-19
- Bipolar Disorder
Other Study ID Numbers
- PG/2021/8551
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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