To Determine the Incidence of Depression in Subjects Affected by Bipolar DisorderNCT05747612
Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in Times of COVID-19.
A study testing Counseling and Coaching in people with To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The goal of this interventional study is to evaluate some outcome parameters at the time of enrollment (T0), during the treatment (T1 and T2) and at the end (T3) of the subjects who will have carried out an individual counseling intervention or mental coaching. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder
- What is being tested?
- Counseling and Coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2020to 1 Feb 2023
- 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
- Recruited subjects have a diagnosis of Bipolar Disorder and are 18 years of age or older.
Who cannot join
- Previous or current intellectual disability in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.
- Patients who are unable to express consent and who do not have a caregiver who can give it for them.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in
The goal of this interventional study is to evaluate some outcome parameters at the time of enrollment (T0), during the treatment (T1 and T2) and at the end (T3) of the subjects who will have carried out an individual counseling intervention or mental coaching. The aim is to determine the incidence of depression, trait anxiety, state anxiety, sleep disorders, resilience, defense mechanisms, distress caused by stressful events in a sample of subjects affected by Bipolar Disorder.
- Being tested
- Counseling and Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling and CoachingOther
Counseling is "the art of helping yourself", that is, a helping relationship based on a series of interventions and stimuli for creativity, aimed at pursuing and maintaining an ever better relational, social and existential quality of life. Coaching is a fundamentally action-oriented method, aimed at concrete changes, the improvement of performance and the achievement of objectives.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Bipolar Disorder | Other | Not described Receives: Other: Counseling and Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of depression, trait anxiety, state anxiety, sleep disorders, resilience, defense mechanisms, distress caused by stressful events in a sample of subjects affected by Bipolar Disorder.
Administration of psychometric scales
Measured: 12 months
Secondary outcomes (1)
To ascertain the presence of evolutionary and maturational trends in the defensive structure especially in the face of a totally unpredictable and unexpected situation such as the COVID-19 pandemic.
Administration of psychometric scales
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Jun 2020
- Primary completion25 Jan 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine the Incidence of Depression in Subjects Affected by Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mazza Marianna, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747612
- Sponsor's protocol ID
- 3275
- Status last verified
- Feb 2023
- First submitted
- 26 Feb 2023
- Last updated
- 1 Mar 2023
- 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 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in
- ClinicalTrials.gov ID
- NCT05747612
- Acronym / sponsor ID
- 3275
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 28 Feb 2023 (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.
The goal of this interventional study is to evaluate some outcome parameters at the time of enrollment (T0), during the treatment (T1 and T2) and at the end (T3) of the subjects who will have carried out an individual counseling intervention or mental coaching. The aim is to determine the incidence of depression, trait anxiety, state anxiety, sleep disorders, resilience, defense mechanisms, distress caused by stressful events in a sample of subjects affected by Bipolar Disorder.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Bipolar Disorder | Other | Other: Counseling and Coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recruited subjects have a diagnosis of Bipolar Disorder and are 18 years of age or older.
Key exclusion criteria (2 listed)
- Previous or current intellectual disability in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.
- Patients who are unable to express consent and who do not have a caregiver who can give it for them.
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 |
|---|---|---|
| Counseling and CoachingCounseling is "the art of helping yourself", that is, a helping relationship based on a series of interventions and stimuli for creativity, aimed at pursuing and maintaining an ever better relational, social and existential quality of life. Coaching is a fundamentally action-oriented method, aimed at concrete changes, the improvement of performance and the achievement of objectives. | Other | Patients with Bipolar Disorder |
Primary outcome
To determine the incidence of depression, trait anxiety, state anxiety, sleep disorders, resilience, defense mechanisms, distress caused by stressful events in a sample of subjects affected by Bipolar Disorder.
Time frame: 12 months
Administration of psychometric scales
1 secondary outcome
To ascertain the presence of evolutionary and maturational trends in the defensive structure especially in the face of a totally unpredictable and unexpected situation such as the COVID-19 pandemic.
Time frame: 12 months
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 1 Mar 2023.
- Individual participant dataSharing planned: No
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 Counseling and Coaching in people with To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 2 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 1 Mar 2023. 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?
To determine the incidence of depression, trait anxiety, state anxiety, sleep disorders, resilience, defense mechanisms, distress caused by stressful events in a sample of subjects affected by Bipolar Disorder. (time frame: 12 months). 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 1 Mar 2023.