Skip to main content
Clinical Trials/NCT05747612
NCT05747612CompletedNot 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 enrollmentStarted: June 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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.

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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-
  • •Patients who are unable to express consent and who do not have a caregiver who can give it for them.

Arms & Interventions

Patients with Bipolar Disorder

Other

Intervention: Counseling and Coaching (Other)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mazza Marianna

Medical Doctor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Sites (1)

Loading locations...

Similar Trials