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

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.

Study Overview

• Status: Completed
• Conditions: To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder
• Intervention / Treatment: Other: Counseling and Coaching

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma
    • Rome, Roma, Italy, 00168
      • Fondazione Policlinico Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients with Bipolar Disorder

Other: Counseling 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: February 26, 2023
• First Submitted That Met QC Criteria: February 26, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: 3275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No