Improving functioning in older adults with bipolar disorder
Efficacy of Functional Remediation for Older-Age Patients With Bipolar Disorder (FROA-BD) as Adjuntive to Pharmacological Treatment Versus Treatment as Usual (TAU)
This study is testing a new therapy called FROA-BD to see if it can help older adults with bipolar disorder improve their daily functioning and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Consorcio Centro de Investigación Biomédica en Red (CIBER) Government |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05186337 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of a new psychological intervention called FROA-BD for older adults over 60 years with bipolar disorder. It is a single-center, single-blind, randomized controlled study comparing the intervention to treatment as usual. Participants will undergo a comprehensive assessment before being randomly assigned to either the experimental group receiving FROA-BD or the control group. The study aims to enhance functional outcomes and quality of life for older adults suffering from bipolar disorder.
Who should consider this trial
Good fit: Ideal candidates are individuals over 60 years old diagnosed with bipolar disorder who are in partial or full remission and experiencing mild to moderate functional impairment.
Not a fit: Patients with an IQ lower than 85 or those who have received structured psychological intervention in the past six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the cognitive functioning and overall quality of life for older adults with bipolar disorder.
How similar studies have performed: While there is limited research specifically targeting older adults with bipolar disorder, similar interventions have shown promise in improving outcomes in younger populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. meeting diagnostic criteria according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for bipolar disorder, either subtype I or II; 2. being aged over 60 years old; 3. 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; 4. presence of mild to moderate functional impairment as measured by the Functional Assessment Short Test (FAST) ≥ 11 5. providing written informed consent to participate. Exclusion Criteria: 1. presenting an Intelligence Quotient (IQ) lower than 85; 2. having been received any kind of structured psychological intervention in the six previous months; 3. 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); 4. presenting any other comorbid psychiatric condition except for sleep and/or anxiety disorders, and 5. having received electroconvulsive therapy in the prior six months.
Where this trial is running
Barcelona
- Hospital Clinic of Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Jose Sanchez-Moreno — Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Study coordinator: Jose Sanchez-Moreno
- Email: jose.sanchez.moreno@cibersam.es
- Phone: +34932275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.