Status:
UNKNOWN
Functional Remediation for Older Adults With Bipolar Disorder
Lead Sponsor:
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Conditions:
Bipolar Disorder
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
Bipolar Disorder (BD) is a chronic and severe mental illness characterized by the emergence of alternating mood episodes which range from extreme depression to manic states. Beyond affective episodes,...
Detailed Description
Study design: This is a single-center, single-blind, randomized, controlled test-retest clinical study to evaluate the efficacy of the FROA-BD in a representative sample of patients with BD over 60 ye...
Eligibility Criteria
Inclusion
- meeting diagnostic criteria according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for bipolar disorder, either subtype I or II;
- being aged over 60 years old;
- being in full or partial remission Young Mania Rating Scale (YMRS) ≤ 10, Hamilton Depression Rating Scale (HDRS) ≤ 14) at the time of the inclusion and assessment;
- presence of mild to moderate functional impairment as measured by the Functional Assessment Short Test (FAST) ≥ 11
- providing written informed consent to participate.
Exclusion
- presenting an Intelligence Quotient (IQ) lower than 85;
- having been received any kind of structured psychological intervention in the six previous months;
- presence of central nervous system (CNS) condition, other than psychiatric, than may influence neurocognitive performance, (such as neurological diseases) or any physical condition that may hamper participation or correct assimilation of the contents of the intervention, (such as severe visual and/or hearing impairment);
- presenting any other comorbid psychiatric condition except for sleep and/or anxiety disorders, and
- having received electroconvulsive therapy in the prior six months.
Key Trial Info
Start Date :
March 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05186337
Start Date
March 15 2023
End Date
June 1 2025
Last Update
July 18 2024
Active Locations (1)
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1
Hospital Clinic of Barcelona
Barcelona, Spain, 08036