NCT05186337Active, not recruiting
Functional Remediation for 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)
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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 50 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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 15 Dec 2021
- Start date
- Mar 2023
- Primary completion date
- Oct 2026
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Diseases
- Bipolar disorder
- NCT number
- NCT05186337
What you commit to
- Study type: Interventional
- Planned participants: 84
- From Mar 2023 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- having been received any kind of structured psychological intervention in the six previous months;
- having received electroconvulsive therapy in the prior six months.
Other illness
- 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
Other
- presenting an Intelligence Quotient (IQ) lower than 85;
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic of Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.