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
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.
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.
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.
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.
For the objective assessment of neurocognitive function two different batteries of tests
have been selected depending of time-point assessment:
(I) Extended battery: Overall cognition will be assessed by means of the Mini Mental
Status Examination (MMSE) and the Spanish version of the Screen for Cognitive Impairment
in Psychiatry (SCIP-S). Both of these brief scales were specifically designed for
detecting cognitive deficits, being the latter specific for psychiatric population. The
SCIP-S has three alternative forms as three different time-points of the study in order
to avoid learning effect bias.
The estimated Intelligence quotient (IQ) will be calculated based on the results in the
Vocabulary subtest from the Wechsler Adult Intelligence Scale (WAIS-III).
The Executive functions will be measured through the computerized Wisconsin Card Sorting
Test (WSCT), the Stroop Color-Word Test (SCWT); the Phonemic (F-A-S) component of the
Controlled Oral Word Association Test (COWAT) the copy of the Rey Osterrieth Complex
Figure (ROCF) and the Trail Making Test-Part B (TMT-B).
Attention will be assessed by using the computerized version of the Continuous
Performance Test (CPT-II) and the Trail Making Test-Part A (TMT-A).
The Working memory index (WM) will be calculated based on the performance in three
subtest from the WAIS-III: Arithmetic, Digits, and Letter-Number sequencing.
The assessment of the Processing speed index will comprise two subtests of the WAIS-III:
the Symbol Search and the Digit-symbol Coding subtests from the WAIS-III.
Verbal Learning and Memory performance will be evaluated through the California Verbal
Learning Test (CVLT).
To examine visual memory The Rey Osterrieth Complex Figure-inmediate recall (ROCF) will
be administered.
Language domain will be examined by means of the Boston Naming Test (BNT) and the
Categorical (Animal Naming) component of the COWAT.
Visuoespatial domain will be assessed by the Juice Line Orientation (JLO). This battery
will be administered at baseline visit (V0) and 12-month follow-up visit after inclusion
(V2), with the exception of vocabulary subtest which only will be applied at baseline
visit since it is a measure of estimated IQ.
(II) Brief cognitive battery: In order to avoid potential learning effects, we selected a
brief cognitive battery consisting of the SCIP-S form 2, the SCWT, the TMT part A and B,
the CPT-II, and the semantic and phonemic components of the COWAT. This brief battery of
test will be administered at post-intervention visit (V1), four months after inclusion.