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

Not Applicable

Completed

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

• Registration Number: NCT05747612
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2022-01-25
• Status Verified: 2023-02
• Study Completion: 2023-02-01
• Study First Submitted: 2023-02-26
• Study First Submitted QC: 2023-02-26
• Last Update Submitted: 2023-02-27
• Study First Posted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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-5.
• Patients who are unable to express consent and who do not have a caregiver who can give it for them.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	12 months	Administration of psychometric scales

Secondary Outcome Measures

Name	Time	Method
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	Administration of psychometric scales

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Rome, Roma, Italy