Bipolar DisorderNCT06296784
An E-health Psychoeducation for People With Bipolar Disorders
A study testing e-health psychoeducation in people with Bipolar Disorder and Psychoeducation, run by University of Cagliari at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Psychoeducation, COVID-19 Pandemic
- What is being tested?
- e-health psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 26 May 2021to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of BD according to DSM-V, over 18 years old
Who cannot join
- do not have bipolar disorder, refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An E-health Psychoeducation Program to Manage Symptoms During COVID-19 Pandemic for People With Bipolar Disorders: a Randomized Controlled Study
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
Read the 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.
- Conditions
- Bipolar Disorder, Psychoeducation, COVID-19 Pandemic
- Being tested
- e-health psychoeducation
- Keywords
- Bipolar Disorder, Psychoeducation, COVID-19 Pandemic
- Medical subject headings
- Bipolar Disorder, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-health psychoeducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| e-health psychoeducation | Experimental | Not described Receives: Other: e-health psychoeducation |
| waiting list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder (GAD-7)
GAD-7 is 7 item self-administered questionnaire evaluates symptoms of an anxiety disorder
Measured: 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
Measured: 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.
Measured: 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.
Measured: T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start26 May 2021
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open-label cross-over randomized controlled trial (two arms)
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- Alessandra Perra
- Responsible party
- Principal investigator, Mauro Giovanni Carta, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296784
- Sponsor's protocol ID
- PG/2021/8551
- Status last verified
- Apr 2024
- First submitted
- 29 Feb 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An E-health Psychoeducation Program to Manage Symptoms During COVID-19 Pandemic for People With Bipolar Disorders: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06296784
- Acronym / sponsor ID
- PG/2021/8551
- Conditions
- Bipolar Disorder, Psychoeducation, COVID-19 Pandemic
- Keywords
- Bipolar Disorder, Psychoeducation, COVID-19 Pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- Alessandra Perra
- Study start
- 26 May 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label cross-over randomized controlled trial (two arms)
| Arm | Type | Receives |
|---|---|---|
| e-health psychoeducation | Experimental | Other: e-health psychoeducation |
| waiting list | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of BD according to DSM-V, over 18 years old
Key exclusion criteria (1 listed)
- do not have bipolar disorder, refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-health psychoeducatione-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. | Other | e-health psychoeducation |
Primary outcome
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-health psychoeducation in people with Bipolar Disorder and Psychoeducation, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder (GAD-7) (time frame: T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.