Functional Remediation for Older Adults With Bipolar Disorder

NCT05186337 | Unknown

• 1 other identifier: PI20/00060
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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, there is consensus considering that cognitive and functional impairment are also core features in a substantial proportion of patients suffering from this mental condition, being both of them responsible of a negative impact on perceived quality of life (QoL). Despite, the association between cognitive performance, clinical and functioning outcomes in patients with BD has been largely explored among adult and middle-aged patients, there is a dearth of research about aging process among older adults with bipolar disoder (OABD) as well as in the design of tailored intervention targeting older individuals. Due to the longer life expectancy and subsequent aging of the world's population, is becoming increasingly common that people presenting with chronic health condition, including BD, survives longer. Currently, it has been estimated roughly the 25% of whole BD population is over 60 years old and it is expected that this percentage will increase up to 50% by 2030. Consequently, there is an urgent need not only to explore specific implication in clinical and neurocognitive course and to investigate symptom development throughout this vital stage elder-life phase, but also to design specific interventions aimed to cope with special needs in this specific population.

Conditions

Bipolar Disorder

Keywords

older adults; bipolar disorder; functional remediation; cognition; functioning; interventions

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be changes in functioning assessed by means of the FAST from baseline to endpoint, post-intervention

  The scale is interviewer-administered, designed for the assessment of psychosocial functioning. The 24 items of the scale are divided among 6 specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. Each individual item is scored from 0 to 3. The global score (0-72) is obtained when the scores of each item are added up. The higher the score, the more serious the difficulties.

  15 days

Study Arms (2)

Experimental

EXPERIMENTAL

Functional Remediation for Older-Age Patients With Bipolar Disorder (FROA-BD)

Behavioral: FROA-BD programme

Control

NO INTERVENTION

The control group (42 patients) will not receive any type of add-on psychotherapy.

Interventions

FROA-BD programme BEHAVIORAL

The experimental group (n=42) will receive a 4-month intervention consisting of 32 sessions of treatment.

Experimental

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• presence of mild to moderate functional impairment as measured by the Functional Assessment Short Test (FAST) ≥ 11
• providing written informed consent to participate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorcio Centro de Investigación Biomédica en Red (CIBER): lead

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Jose Sanchez-Moreno

  Consorcio Centro de Investigación Biomédica en Red (CIBER)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Sanchez-Moreno

CONTACT

+34932275400; jose.sanchez.moreno@cibersam.es

Esther Jimenez

CONTACT

+34932275400; ejimene1@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 11, 2022
• Study Start: March 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 18, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)