Efficacy of Functional Remediation for Older-Age Patients With Bipolar Disorder (FROA-BD) as Adjuntive to Pharmacological Treatment Versus Treatment as Usual (TAU)

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 years old. This study will be carried out in the Bipolar and Depressive Disorders Unit at the Hospital Clinic of Barcelona, which takes part of the Spanish network Center for Biomedical Research in Mental Health (CIBERSAM0029. It will include two parallel arms (1:1) in order to assess the efficacy of a new psychological intervention as add-on therapy compared with treatment as usual to enhance functional outcome in OABD. This project has been approved by the Ethical Comittee of the Hospital Clinic of Barcelona and it will be carried up in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice in compliance with the data protection law in force and anonymization of the collected information.

Procedure All participants will be examined at baseline prior to inclusion in the study, using an extensive battery of questionnaires and tools aimed to assess main demographic, clinical, functioning, quality of life, well-being, and neurocognitive variables. Once the baseline assessment has been carried out, patients will be randomly allocated into the experimental group, which will receive the FROA-BD programme, or to the control group, which will be treated as usual (TAU). Four months later, when the intervention will be finished, all study participants will be assessed, especially on those areas that are supposed to be targeted by the FROA-BD programme (functional outcome as the main outcome, and neurocognitive performance, clinical symptoms, and quality of life and well-being as secondary outcomes), trying to avoid potential re-assessment learning effect by using alternative versions or tests. Finally, one year after inclusion (8 months after completion of the intervention), a complete assessment, mostly identical to which was used at baseline, will be performed (See Figure 1). In addition to the aforementioned assessment visits, all participants will also be followed up pharmacologically at the Bipolar and Depressive Disorder Unit of the Hospital Clinic of Barcelona, following the guidelines of good clinical practice. Research members involved in assessment will be blind to condition group (FROA-BD or TAU). Two clinical neuropsychologist (therapist and co-therapist) blind to baseline assessment results will conduct the FROA-BD intervention.

Data collection

1. Demographic, clinical variables and comorbidity A semi-structured clinical interview based on the SCID-5 will be administered to gather main demographic and clinical variables. The HDRS and the YMRS will be used to evaluate the presence of depressive and manic symptomatology, respectively. The Cumulative Illness Rating Scale-Geriatrics (CIRS-G) Spanish version will be administered in order to assess the presence of any somatic comorbid condition. Medical records will be also reviewed and considered.
2. Psychosocial functioning, quality of life and well-being Functional outcome will be assessed by the means of the FAST. This interviewer-administered brief scale, which comprises 24 items, was specifically designed to explore functional difficulties in psychiatric population among six specific functional domains (autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time). Overall scores range from 0 to 72, being higher scores indicators of a worse functional impairment.

Quality of life and well-being will be assessed using the Spanish version of the Short Form-36 Health Survey (SF-36) and the Spanish version of the World Health Organisation-Five Well-Being Index (WHO-5), respectively. The SF-36 is self-administered questionnaire which consists of 36 questions measuring eight separate dimensions related to quality of life (physical functioning, role limitation-physical, role limitation-emotional, vitality, mental health, social functioning, pain, and general health). Higher scores indicate better quality of life. WHO-5 is a self-administered short test consisting of 5 items rated on a 6-point scale assessing how the individual has been feeling over the last two weeks. Raw score ranges from 0 to 25. The higher scores the better perceived subjective well-being. In order to obtain the feedback from the patients, we also will consider the patient's satisfaction with the intervention through a self-applied instrument measured in likert scale (from 0 to 10) where the maximum score corresponds to completely satisfied. 3. Cognitive Reserve The Cognitive Reserve Assessment Scale in Health (CRASH) is an interviewer-administered, quick and easy-to-apply tool which was designed to evaluate cognitive reserve in psychiatric patients, especially in those suffering from severe mental conditions. This 23-item scale assess the three domains: education, occupation and intellectual and leisure activities, which are the main domains involved in cognitive reserve. This scale provides an overall score as well as a score for each assessed domain. The maximum score is 90. Higher scores indicate higher cognitive reserve. 4. Neuropsychological assessment In this study we will to assess cognitive performance both from the subjective and objective perspective. For gathering data regarding subjective cognitive complaints, we will use the Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA). This self-administered instrument consist of 16 items which are rated on a 4-point scale ((0) never; (1) sometimes; (2) frequently; (3) always). COBRA total score results is calculated by totaling all item scores and higher scores indicate a worse subjective cognitive performance.