Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05186337 |
| Other study ID # |
PI20/00060 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2023 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
August 2023 |
| Source |
Consorcio Centro de Investigación Biomédica en Red (CIBER) |
| Contact |
Jose Sanchez-Moreno |
| Phone |
+34932275400 |
| Email |
jose.sanchez.moreno[@]cibersam.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
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.
