Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in Times of COVID-19.
Primary Purpose
To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Counseling and Coaching
Sponsored by
About this trial
This is an interventional screening trial for To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder
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-5. Patients who are unable to express consent and who do not have a caregiver who can give it for them.
Sites / Locations
- Fondazione Policlinico Gemelli IRCCS
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with Bipolar Disorder
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05747612
First Posted
February 26, 2023
Last Updated
February 27, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05747612
Brief Title
Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in Times of COVID-19.
Official Title
Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with Bipolar Disorder
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Counseling and Coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Administration of psychometric scales
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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.
Description
Administration of psychometric scales
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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-5.
Patients who are unable to express consent and who do not have a caregiver who can give it for them.
Facility Information:
Facility Name
Fondazione Policlinico Gemelli IRCCS
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in Times of COVID-19.
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