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Clinical Trials/NCT05747612
NCT05747612
Completed
Not Applicable

Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country50 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
50
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
February 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mazza Marianna

Medical Doctor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Previous or current intellectual disability in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-
  • Patients who are unable to express consent and who do not have a caregiver who can give it for them.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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.(12 months)

Study Sites (1)

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