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

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Completed
• CT.gov ID: NCT05747612
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Actual Duration (Months): 32
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder	Other: Counseling and Coaching	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Jan 25, 2022
• Actual Study Completion Date: Feb 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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. [12 months]

   Administration of psychometric scales

Secondary Outcome Measures

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. [12 months]

   Administration of psychometric scales

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Gemelli IRCCS	Rome	Roma	Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mazza Marianna, Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05747612
• Other Study ID Numbers: 3275
• First Posted: Feb 28, 2023
• Last Update Posted: Mar 1, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bipolar Disorder

Study Results

No Results Posted as of Mar 1, 2023