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CompletedNCT05747612Updated Mar 1, 2023

Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in Times of COVID-19.

An interventional study of Counseling and Coaching in To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Jun 2020, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder

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03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 50 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Recruited subjects have a diagnosis of Bipolar Disorder and are 18 years of age or older.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Other
    Patients with Bipolar Disorder

    Other: Counseling and Coaching

Interventions

  • OtherCounseling and Coaching

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 12 months

07

Study locations

1 site
  • Fondazione Policlinico Gemelli IRCCS
    Rome, Roma 00168, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05747612
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Mazza Marianna (Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Feb 28, 2023
Start date
Jun 1, 2020
Primary completion
Jan 25, 2022
Completion
Feb 1, 2023
Last update
Mar 1, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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